阅读说明：本技术 玛卡组合物和使用方法 (Maca compositions and methods of use ) 是由 J·R·科莫罗夫斯基 S·P·奥哈尔沃 于 2017-10-24 设计创作，主要内容包括：本申请涉及包含多种玛卡提取物的组合物以及这些组合物用于治疗某些疾病、病症和病况的用途。(The present application relates to compositions comprising various maca extracts and the use of these compositions for treating certain diseases, disorders, and conditions.)

1. A composition comprising an amount of black maca and an amount of red maca, wherein the amounts have a ratio of black maca to red maca.

2. The composition of claim 1, wherein the ratio is about 4: 1.

3. The composition of claim 1, wherein the amount of black maca and the amount of red maca are provided in a synergistic ratio.

4. The composition of claim 1, wherein the composition is for improving mitochondrial function.

5. The composition of claim 1, wherein the composition is for increasing energy.

6. The composition of claim 1, wherein the composition is for reducing fatigue.

7. The composition of claim 1, wherein the composition is for increasing physical endurance.

8. The composition of claim 1, wherein the composition is for increasing anaerobic working capacity.

9. The composition of claim 1, wherein the composition is for reducing the formation of lactic acid.

10. The composition of claim 1, wherein the composition comprises about 15 to about 40 grams total sugar per 100 grams of the composition.

11. The composition of claim 1, wherein the composition comprises from about 10 to about 15 grams of protein per 100 grams of the composition.

12. The composition of claim 1, wherein the composition comprises from about 9000 to about 12000mg of total amino acids per 100 grams of the composition.

13. The composition of claim 1, wherein the composition has a pH of less than 5.4.

14. A composition consisting essentially of an amount of black maca and an amount of red maca, wherein the amount has a ratio of black maca to red maca, wherein the ratio is about 4: 1.

Background

The present disclosure relates to novel compositions of maca root (also known as peruvian ginseng) and methods of use thereof. Such compositions may be used in improved methods such as: enhancing sexual desire, improving sexual dysfunction caused by antidepressants, reducing inflammation, increasing energy levels, increasing endurance, increasing motor performance, improving memory, improving menstrual-related discomfort, improving symptoms of hormonal imbalance, HIV/AIDS, cancer (including discomfort caused by treatment of cancer with chemotherapy), menopause, andropause, anemia, osteoporosis, and chronic fatigue syndrome, increasing fertility, reducing symptoms of tuberculosis, improving mood (e.g., reducing depression), and increasing immune function.

More specifically, the present disclosure relates to the surprising and unexpected discovery that a particular maca root variety combination is more effective in reducing inflammatory markers (e.g., cytokines) than other maca root varieties alone or in other combinations, and thus may be more effective and/or provide more beneficial results to subjects ingesting the compositions disclosed herein than prior products containing maca root.

Maca is used as a food, similar to sweet potatoes, but also has many medicinal properties. Traditionally, maca is processed by boiling, roasting and drying the roots, and then grinding the dried root material into a powder. Various maca root powders are commercially available. Fresh maca roots have different colors due to genetic variation resulting in different phytochemical characteristics in different maca phenotypes. The different genotypes reflected in the root color phenotype include yellow, red, purple, blue, black and green. The yellow maca taste is the largest and sweet and is most commonly grown for food, while red and black macas are generally considered more efficacious (e.g., to reduce inflammation).

Inflammation is part of a non-specific immune response that occurs in response to physical injury. Among other factors, cytokines are modulators of inflammatory processes. Cytokines are small secreted proteins that have specific roles in cell-cell interactions and communication. There are both pro-inflammatory cytokines and anti-inflammatory cytokines.

For example, interleukin 6(IL-6) has a wide range of physiological effects, including pro-inflammatory and anti-inflammatory, depending on the biological background. IL-6 is involved in a number of disease processes, including chronic inflammation, diabetes and rheumatoid arthritis. Although IL-6 is a promising target for clinical intervention, its complex signal transduction pathways make such intervention challenging.

Inflammation may also lead to sexual problems (or sexual dysfunction). These conditions are common and have a negative impact on mood, well-being and interpersonal relationships. Most sexual problems are associated with sexual craving (libido) and male Erectile Dysfunction (ED) in both women and men. Current pharmacological interventions for treating sexual problems include medications, intraperitoneal therapy, and male penile prosthesis implantation, as well as female hormonal therapy. There are also problems with the treatment of female sexual problems, and pharmacological treatment often results in serious, undesirable side effects. Non-pharmacological treatments include vaginal myoelectrical biofeedback, pelvic floor physiotherapy, cognitive behavioral therapy, transcutaneous electrical nerve stimulation, and vestibulectomy. Postmenopausal women may also suffer from decreased libido, in part due to decreased estrogen and testosterone levels. Decreased libido remains a significant sexual problem for both men and women.

Brief description of the invention

The present application is based, in part, on the surprising discovery that certain maca root mixtures provide an unexpected increase in the reduction of the anti-inflammatory response of cells. In some aspects, the maca root mixture may be used to treat, ameliorate and/or prevent an inflammatory response. In some aspects, the maca root mixtures disclosed herein may be used to increase libido and/or treat, ameliorate or prevent symptoms of sexual dysfunction. After considering this disclosure, and particularly after reading the section entitled "detailed description" one will understand how the features of the compositions and methods disclosed herein provide advantages over other known compositions and methods.

Embodiments disclosed herein relate to compositions comprising, consisting essentially of, or consisting of a mixture of one or more maca roots. Such compositions are useful, for example, for reducing an inflammatory response in an individual. In some aspects, the composition comprises a maca root mixture of one or more of the phenotypes (colors) of maca roots. In some aspects, one or more maca root phenotypes are pulverized into a powder. In some aspects, the composition comprises a macamide-macaene (macamene) mixture. In some embodiments, the maca roots used in the maca composition are selected based on their macamide and/or macaene (macamene) content.

Other embodiments disclosed herein relate to the use of such compositions. These compositions are particularly useful for increasing anti-inflammatory properties and reducing the production of inflammatory cytokines, which would necessarily affect many of the pathways affected by anti-inflammatory pathways, including but not limited to increasing libido and reducing the effects of chronic inflammation. In some embodiments, the compositions disclosed herein can be used to treat or enhance sexual motivation in individuals experiencing menopause or other hormonal imbalances.

Some embodiments provide methods for increasing sexual motivation in an individual with a hormonal imbalance. For example, the method may comprise administering to the subject an effective amount of a maca root mixture. The subject's desire to participate in sexual activity may be increased relative to not providing maca root or other maca root blends.

In another aspect, embodiments relate to methods of treating a subject with a composition disclosed herein. The terms "subject", "patient" or "individual" as used herein refer to a vertebrate, preferably a mammal, more preferably a human. "mammal" may refer to any animal classified as a mammal, including humans, domestic and farm animals, and zoo, sports, or pet animals, such as horses, sheep, cattle, pigs, dogs, cats, and the like. Preferably, the mammal is a human.

In some embodiments, the composition comprises black maca root, yellow maca root, red maca root, or any combination of the foregoing.

In some embodiments, the maca root mixture comprises a combination of black maca and yellow maca. In some embodiments, the maca root mixture comprises some combination of black maca and red maca. In some embodiments, the maca root mixture comprises some combination of red and yellow macas. In some embodiments, the maca root mixture is a one-to-one ratio of the two maca root phenotypes. In some embodiments, the maca root mixture is a two to one ratio of the two maca root phenotypes. In some embodiments, the maca root mixture is a four-to-one ratio of two maca root phenotypes.

Some embodiments are formulated as nutritional supplements. These supplements may be formulated for daily consumption. For example, a nutritional supplement containing maca may be formulated to deliver from about 1 to about 40 grams of maca root per day to each individual subject. This may occur in one, two, three or more doses during the day, and may occur daily over a period of one, two, three or more days or weeks, as well as longer periods as contemplated by those skilled in the art.

In some embodiments, the maca root is present in an effective amount. In some embodiments, the supplement is a solid. In some embodiments, the solid is a powder. In some embodiments, the supplement is a liquid. In some embodiments, the liquid is a concentrated formulation. In some embodiments, the supplement further comprises at least one of a sweetener and a flavoring agent.

Some embodiments provide methods of making a composition comprising a maca root mixture and an excipient. The method may include boiling, baking and drying the maca root and mixing with some amount of excipients.

Some embodiments provide methods of making a composition comprising a maca root mixture and an excipient. In some embodiments, the composition is further formulated for oral administration to a subject.

In some embodiments, the nutritional supplement further comprises a second agent. In some embodiments, the second agent is selected from the group consisting of hormones, non-steroidal anti-inflammatory drugs, vitamins, minerals, and combinations of the foregoing.

Some embodiments provide a composition comprising an amount of black maca root and an amount of red maca root, wherein the amount has a ratio of black maca root to red maca root, and the ratio is about 1: 1 to about 4: 1. some embodiments provide a composition comprising an amount of maca root and an amount of maca root, wherein the amount has an amount of maca root: the proportion of red maca root, and the proportion is about 1: 1 to about 4: 1. some embodiments provide a composition comprising an amount of black maca root and an amount of yellow maca root, wherein the amount has a ratio of black maca root: a proportion of yellow maca root, and the proportion is about 2: 1 to 1: 2.

some embodiments provide a method of increasing sexual desire in a subject in need thereof, comprising co-administering to the subject a composition comprising synergistically effective amounts of black maca root and red maca root. Some embodiments provide a method of increasing sexual desire in a subject in need thereof, comprising co-administering to the subject a composition comprising synergistically effective amounts of black maca root and yellow maca root.

Some embodiments provide a method of reducing cytokine activity in a subject in need thereof, comprising administering to the subject a composition comprising synergistically effective amounts of black maca root to red maca root, wherein the cytokine is selected from the group consisting of IL-1 β, IL-6, IL-8, and combinations thereof. Some embodiments provide a method of reducing cytokine activity in a subject in need thereof, comprising administering to the subject a composition comprising synergistically effective amounts of black maca root to yellow maca root, wherein the cytokine is selected from the group consisting of IL-1 β, IL-6, IL-8, IP-10, IL-4, IFN- γ, and combinations thereof.

Some embodiments provide for the use of a composition comprising a first amount of maca root and a second amount of maca root, the first and second amounts being provided in a synergistic ratio, for improving the treatment of sexual dysfunction in a human. Some embodiments provide for the use of a composition comprising a first amount of black maca root and a second amount of yellow maca root, the first and second amounts being provided in a synergistic ratio, for improving treatment of sexual dysfunction in a human.

Some embodiments provide a composition consisting essentially of from about 1: 4 ratio of black maca root to red maca root for use in the treatment of sexual dysfunction. Some embodiments provide a composition comprising an amount of black maca root and an amount of jute root, wherein the amount has a ratio of black maca root to jute root and the ratio is from about 1: 1. some embodiments provide a composition consisting essentially of from about 1: a composition of black maca root and yellow maca root in a ratio of 1 for use in the treatment of sexual dysfunction.

Some embodiments provide improved methods of increasing libido. Some embodiments provide improved methods of ameliorating sexual dysfunction caused by antidepressants. Some embodiments provide improved methods of reducing inflammation. In some embodiments, the methods comprise providing a composition comprising an effective amount of at least two of black maca root, yellow maca root, and red maca root. In some embodiments, the ratio of the two phenotypes is about 1: 1 to about 4: 1.

some embodiments provide improved methods of increasing energy levels. Some embodiments provide improved methods of increasing endurance. Some embodiments provide improved methods of improving athletic performance. In some embodiments, the methods comprise providing a composition comprising an effective amount of at least two of black maca root, yellow maca root, and red maca root. In some embodiments, the ratio of the two phenotypes is about 1: 1 to about 4: 1.

some embodiments provide improved methods of improving memory. In some embodiments, the methods comprise providing a composition comprising an effective amount of at least two of black maca root, yellow maca root, and red maca root. In some embodiments, the ratio of the two phenotypes is about 1: 1 to about 4: 1.

some embodiments provide improved methods of ameliorating menstrual-related discomfort. Some embodiments provide improved methods of ameliorating symptoms of hormonal imbalance. Some embodiments provide improved methods of ameliorating menopausal symptoms. Some embodiments provide improved methods of ameliorating male climacteric symptoms. Some embodiments provide improved methods of ameliorating the symptoms of osteoporosis. Some embodiments provide improved methods of improving symptoms of increased fertility. In some embodiments, the methods comprise providing a composition comprising an effective amount of at least two of black maca root, yellow maca root, and red maca root in a ratio. In some embodiments, the ratio is about 1: 1 to about 4: 1.

some embodiments provide improved methods of ameliorating the symptoms of HIV/AIDS. Some embodiments provide improved methods of ameliorating the symptoms of cancer. Some embodiments provide improved methods of ameliorating the discomfort associated with administration of chemotherapy to treat cancer. In some embodiments, the methods comprise providing a composition comprising an effective amount of at least two of black maca root, yellow maca root, and red maca root. In some embodiments, the ratio of the two phenotypes is about 1: 1 to about 4: 1.

some embodiments provide improved methods of ameliorating symptoms of anemia. Some embodiments provide improved methods of ameliorating the symptoms of chronic fatigue syndrome. Some embodiments provide improved methods of reducing the symptoms of tuberculosis. Some embodiments provide improved methods of improving mood (e.g., reducing depression). Some embodiments provide improved methods of enhancing immune function. In some embodiments, the methods comprise providing a composition comprising an effective amount of at least two of black maca root, yellow maca root, and red maca root. In some embodiments, the ratio of the two phenotypes is about 1: 1 to about 4: 1.

some embodiments provide improved mitochondrial function. Some embodiments provide improved methods of improving mitochondrial function. Some embodiments provide improved methods of increasing energy. In some embodiments, these compositions and methods comprise providing a composition comprising an effective amount of at least two of black maca root, yellow maca root, and red maca root. In some embodiments, the ratio of the two phenotypes is about 1: 1 to about 4: 1.

some embodiments provide a composition comprising an amount of maca root and an amount of maca root, wherein the amount has an amount of maca root: the proportion of red maca root, and the proportion is about 1: 1 to about 4: 1.

some embodiments provide a method of increasing sexual desire in a subject in need thereof, comprising co-administering to the subject a composition comprising synergistically effective amounts of black maca root and red maca root.

Some embodiments provide a method of reducing cytokine activity in a subject in need thereof, comprising administering to the subject a composition comprising synergistically effective amounts of maca root and maca root, wherein the cytokine is selected from the group consisting of IL-1 β, IL-6, IL-8, and combinations thereof.

Some embodiments provide a method of treating sexual dysfunction in a human comprising administering a composition comprising a first amount of maca root and a second amount of maca root, the first and second amounts being provided in a synergistic ratio.

Some embodiments provide for the use of a composition for improving treatment of sexual dysfunction in a human comprising administering a composition comprising a first amount of maca root and a second amount of maca root, the first and second amounts being provided in a synergistic ratio.

Some embodiments provide for the use of a composition for reducing muscle fatigue in a human comprising administering a composition comprising a first amount of maca root and a second amount of maca root, the first and second amounts being provided in a synergistic ratio. Some embodiments provide for the use of a composition for reducing mental fatigue in a human comprising administering a composition comprising a first amount of maca root and a second amount of maca root, the first and second amounts being provided in a synergistic ratio. Some embodiments provide a use of a composition for increasing physical performance in a human, comprising administering a composition comprising a first amount of black maca root and a second amount of red maca root, the first and second amounts being provided in a synergistic ratio. In some embodiments, physical, mental, or muscle fatigue may be reduced during physical activity. Some embodiments provide for the use of a composition as described herein to increase endurance (such as, but not limited to, physical endurance) in a human. Some embodiments provide for the use of a composition as described herein to increase the ability of a human to apply physical force, such as, but not limited to, during exercise. Some embodiments provide for the use of a composition as described herein to increase the aerobic capacity of a human. Some embodiments provide for the use of a composition as described herein to increase the anaerobic working capacity of a human. Some embodiments provide for the use of a composition as described herein to increase the length of time that a person may apply physical force (e.g., without limitation, during exercise).

Some embodiments provide for the use of a composition as described herein for reducing the effects of physical activity in a human, comprising administering a composition as described herein. Reducing effects may include, but are not limited to, reducing lactate (lactate) formation, reducing liver glycogen, reducing serum malondialdehyde, reducing muscle malondialdehyde, reducing liver malondialdehyde, reducing alanine aminotransferase, reducing aspartate aminotransferase, and/or reducing cytokine activity. Reducing the effect of a physical activity may mean that the effect experienced by a subject (e.g., a person) is reduced or improved during or after the physical activity for a period of time that may be readily determined by one skilled in the art depending on the context in which it is used.

Some embodiments provide a use of a composition for reducing lactic acid in a human comprising administering a composition comprising a first amount of maca root and a second amount of maca root, the first and second amounts being provided in a synergistic ratio. In certain embodiments, reducing lactic acid in a human may be performed during physical activity. In some embodiments, the lactic acid may be reduced by about 10 to about 50%, about 15 to about 45%, about 25 to about 50%, about 20 to about 50%, about 45%, about 50%, and ranges therebetween.

Some embodiments provide a use of a composition for reducing liver glycogen in a human, comprising administering a composition comprising a first amount of maca root and a second amount of maca root, the first and second amounts provided in a synergistic ratio. In certain embodiments, reducing liver glycogen in a human may be performed during physical activity. In some embodiments, liver glycogen can be reduced by about 10 to about 40%, about 15 to about 35%, about 25 to about 35%, about 20 to about 40%, about 25%, about 35%, and ranges therebetween.

Some embodiments provide a use of a composition for reducing serum Malondialdehyde (MDA) in a human, comprising administering a composition comprising a first amount of black maca root and a second amount of red maca root, the first and second amounts provided in a synergistic ratio. In certain embodiments, reducing serum MDA in a human may be performed during physical activity. In some embodiments, serum MDA may be reduced by about 20 to about 40%, about 25 to about 35%, about 20 to about 35%, about 25%, about 35%, and ranges therebetween.

Some embodiments provide a use of a composition for reducing human muscle MDA in a human comprising administering a composition comprising a first amount of maca root and a second amount of maca root, the first and second amounts being provided in a synergistic ratio. In certain embodiments, reducing muscle MDA in a human may be performed during physical activity. In some embodiments, muscle MDA may be reduced by about 15% to about 30%, about 20% to about 25%, about 20% to about 30%, about 25%, about 20%, and ranges therebetween.

Some embodiments provide for use of a composition for reducing hepatic MDA in a human comprising administering a composition comprising a first amount of maca root and a second amount of maca root, the first and second amounts provided in a synergistic ratio. In certain embodiments, reducing hepatic MDA in a human may be performed during physical activity. In some embodiments, liver MDA may be reduced by about 20% to about 25%, about 15% to about 25%, about 20% to about 30%, about 22%, about 23%, and ranges therebetween.

Some embodiments provide a use of a composition for increasing liver superoxide dismutase (SOD) in a human comprising administering a composition comprising a first amount of maca root and a second amount of maca root, the first and second amounts provided in a synergistic ratio. In certain embodiments, increasing liver SOD in a human may be performed during physical activity. In some embodiments, the liver SOD may be increased by about 5% to about 15%, about 5% to about 10%, about 7%, about 10%, and ranges therebetween.

Some embodiments provide for the use of a composition for increasing muscle SOD in a human comprising administering a composition comprising a first amount of maca root and a second amount of maca root, the first and second amounts being provided in a synergistic ratio. In certain embodiments, increasing muscle SOD in a human may be performed during physical activity. In some embodiments, the muscle SOD may be increased by about 5% to about 10%, about 5% to about 15%, about 7% to about 10%, about 7%, about 6%, and ranges therebetween.

Some embodiments provide a use of a composition for increasing hepatic glutathione peroxidase (GSH-Px) in a human, comprising administering a composition comprising a first amount of black maca root and a second amount of red maca root, the first and second amounts provided in a synergistic ratio. In certain embodiments, increasing liver GSH-Px in a human may be performed during physical activity. In some embodiments, the liver GSH-Px may be increased by about 2% to about 10%, about 3% to about 5%, about 3% to about 8%, about 4%, about 6%, and ranges therebetween.

Some embodiments provide for the use of a composition for increasing muscle GSH-Px in a human, comprising administering a composition comprising a first amount of maca root and a second amount of maca root, the first and second amounts being provided in a synergistic ratio. In certain embodiments, increasing muscle GSH-Px in a human may be performed during physical activity. In some embodiments, the muscle GSH-Px is increased by about 20% to about 50%, about 25% to about 30%, about 25% to about 45%, about 35% to about 50%, about 40% to about 50%, about 25%, about 45%, about 27%, about 44%, and ranges therebetween.

Some embodiments provide a use of a composition for reducing alanine Aminotransferase (ALT) in a human comprising administering a composition comprising a first amount of black maca root and a second amount of red maca root, the first and second amounts provided in a synergistic ratio. In certain embodiments, reducing ALT in a human may be performed during physical activity. In some embodiments, ALT may be reduced by up to about 10%, about 5% to about 10%, about 5%, about 4%, about 1%, and ranges therebetween.

Some embodiments provide a use of a composition for reducing aspartate Aminotransferase (AST) in a human comprising administering a composition comprising a first amount of black maca root and a second amount of red maca root, the first and second amounts provided in a synergistic ratio. In certain embodiments, reducing AST in a human may be performed during physical activity. In some embodiments, AST may be reduced by about 5% to about 20%, about 10% to about 20%, about 15% to about 20%, about 13%, about 15%, and ranges therebetween.

Some embodiments provide a use of a composition for reducing total cholesterol in a human comprising administering a composition comprising a first amount of maca root and a second amount of maca root, the first and second amounts being provided in a synergistic ratio. In certain embodiments, reducing total cholesterol in a human may be performed during a physical activity. In some embodiments, total cholesterol may be reduced by about 10% to about 25%, about 15% to about 25%, about 20%, about 15%, about 22%, about 14%, and ranges therebetween.

Some embodiments provide a use of a composition for reducing triglycerides in a human comprising administering a composition comprising a first amount of maca root and a second amount of maca root, the first and second amounts being provided in a synergistic ratio. In certain embodiments, reducing triglycerides in a human may be performed during physical activity.

Some embodiments provide a use of a composition for reducing nuclear factor NF- κ B in a human, comprising administering a composition comprising a first amount of black maca root and a second amount of red maca root, the first and second amounts provided in a synergistic ratio. In certain embodiments, reducing NF- κ B in a human may be performed during physical activity. In some embodiments, the NF- κ B may be reduced by about 15% to about 25%, about 10% to about 20%, about 25%, and ranges therebetween.

Some embodiments provide methods of modulating a Sirtuin pathway using a composition as described herein. Some embodiments provide a use of a composition for increasing SIRT-1 in a human comprising administering a composition comprising a first amount of maca root and a second amount of maca root, the first and second amounts being provided in a synergistic ratio. In certain embodiments, increasing SIRT-1 in a human may be performed during physical activity. In some embodiments, SIRT-1 may be increased by about 25% to about 50%, up to about 50%, about 25% to about 70%, about 25%, about 35%, about 45%, about 50%, about 60%, and ranges therebetween.

Some embodiments provide a use of a composition for increasing mitochondrial transcription factor a (tfam) in a human, comprising administering a composition comprising a first amount of black maca root and a second amount of red maca root, the first and second amounts provided in a synergistic ratio. In certain embodiments, increasing TFAM in a human may be performed during physical activity. In some embodiments, TFAM is increased by about 25% to about 50%, up to about 50%, about 25% to about 70%, about 25%, about 35%, about 45%, about 50%, about 60%, and ranges therebetween.

Some embodiments provide a use of a composition for increasing nuclear respiratory factor 1(Nrf-1) in a human comprising administering a composition comprising a first amount of black maca root and a second amount of red maca root, the first and second amounts being provided in a synergistic ratio. In certain embodiments, increasing Nrf-1 in a human may be performed during physical activity. In some embodiments, Nrf-1 may be increased by about 50% to about 100%, about 25% to about 75%, about 50% to about 75%, about 75% to about 100%, about 50%, about 75%, about 100%, about 150%, about 100% to about 150%, about 200%, about 100% to about 200%, about 200% to about 300%, about 200%, about 300%, and ranges therebetween.

Some embodiments provide a use of a composition for increasing nuclear factor red blood cell 2(Nrf-2) in a human, comprising administering a composition comprising a first amount of black maca root and a second amount of red maca root, the first and second amounts being provided in a synergistic ratio. In certain embodiments, increasing Nrf-2 in a human may be performed during physical activity. In some embodiments, Nrf-2 may be increased by about 25% to about 50%, up to about 50%, about 25% to about 70%, about 25%, about 35%, about 45%, about 50%, about 60%, and ranges therebetween.

Some embodiments provide a use of a composition for increasing peroxisome proliferator activated receptor-gamma coactivator (PGC-1) in a human comprising administering a composition comprising a first amount of black maca root and a second amount of red maca root, the first and second amounts being provided in a synergistic ratio. In certain embodiments, increasing PGC-1 in a human may be performed during physical activity. In some embodiments, PGC-1 is increased by about 25% to about 50%, up to about 50%, about 25% to about 70%, about 25%, about 35%, about 45%, about 50%, about 60%, and ranges therebetween.

Some embodiments provide a composition consisting essentially of from about 1: 4 ratio of black to red maca root.

Some embodiments provide a use of a composition for improving therapeutic sexual dysfunction in a human comprising administering a composition consisting essentially of about 1: 4 proportion of the composition consisting of black maca root and red maca root.

Some embodiments provide a composition comprising an amount of black maca root and an amount of yellow maca root, wherein the amount has a ratio of black maca root: a proportion of yellow maca root, and the proportion is about 1: 1.

some embodiments provide a method of increasing sexual desire in a subject in need thereof, comprising co-administering to the subject a composition comprising synergistically effective amounts of black maca root and yellow maca root.

Some embodiments provide a method of reducing cytokine activity in a subject in need thereof, comprising administering to the subject a composition comprising synergistically effective amounts of black maca root and yellow maca root, wherein the cytokine is selected from the group consisting of IL-1 β, IL-6, IL-8, IP-10, IL-4, IFN- γ, and combinations thereof.

Some embodiments provide a method of treating sexual dysfunction in a human comprising administering a composition comprising a first amount of black maca root and a second amount of yellow maca root, the first and second amounts provided in a synergistic ratio.

Some embodiments provide for the use of a composition for improving treatment of sexual dysfunction in a human comprising administering a composition comprising a first amount of black maca root and a second amount of yellow maca root, the first and second amounts provided in a synergistic ratio.

Some embodiments provide a composition consisting essentially of from about 1: 1 proportion of the composition consisting of black maca root and yellow maca root.

Some embodiments provide a use of a composition for improving therapeutic sexual dysfunction in a human comprising administering a composition consisting essentially of about 1: 1 proportion of the composition consisting of black maca root and yellow maca root.

A composition consisting essentially of about 1: a composition of black maca root and yellow maca root in a ratio of 1 for use in the treatment of sexual dysfunction.

A more complete understanding of the composition, methods, and uses of the compositions will be obtained by those skilled in the art, and additional advantages and objects will be realized by consideration of the following detailed description.

Brief Description of Drawings

The accompanying drawings disclose illustrative embodiments. Not all embodiments are shown. Other embodiments may additionally or alternatively be used. It should be understood that these drawings depict only several embodiments in accordance with the disclosure and are not to be considered limiting of its scope; the present disclosure will be described with additional specificity.

FIG. 1 shows the change in IL-1 β levels in PBMC (peripheral blood mononuclear cells) culture supernatants treated with serial dilutions of the test product in the presence of bacterial Lipopolysaccharide (LPS) for 24 hours. Data are shown as group mean plus or minus standard deviation for each replicate data set when compared to mean cytokine production for LPS-treated cultures in the absence of test product.

FIG. 2 shows the change in IL-4 levels in supernatants of PBMC cultures treated with serial dilutions of the test product for 24 hours in the presence of bacterial Lipopolysaccharide (LPS). Data are shown as group mean plus or minus standard deviation for each replicate data set when compared to mean cytokine production for LPS-treated cultures in the absence of test product.

FIG. 3 shows the change in IL-6 levels in supernatants of PBMC cultures treated with serial dilutions of the test product for 24 hours in the presence of bacterial Lipopolysaccharide (LPS). Data are shown as group mean plus or minus standard deviation for each replicate data set when compared to mean cytokine production for LPS-treated cultures in the absence of test product.

FIG. 4 shows the change in IL-8 levels in supernatants of PBMC cultures treated with serial dilutions of the test product for 24 hours in the presence of bacterial Lipopolysaccharide (LPS). Data are shown as group mean plus or minus standard deviation for each replicate data set when compared to mean cytokine production for LPS-treated cultures in the absence of test product.

FIG. 5 shows the change in IL-10 levels in supernatants of PBMC cultures treated with serial dilutions of the test product for 24 hours in the presence of bacterial Lipopolysaccharide (LPS). Data are shown as group mean plus or minus standard deviation for each replicate data set when compared to mean cytokine production for LPS-treated cultures in the absence of test product.

FIG. 6 shows the change in IFN- γ levels in supernatants of PBMC cultures treated with serial dilutions of the test product for 24 hours in the presence of bacterial Lipopolysaccharide (LPS). Data are shown as group mean plus or minus standard deviation for each replicate data set when compared to mean cytokine production for LPS-treated cultures in the absence of test product.

FIG. 7 shows the change in TNF-. alpha.levels in supernatants of PBMC cultures treated with serial dilutions of the test product for 24 hours in the presence of bacterial Lipopolysaccharide (LPS). Data are shown as group mean plus or minus standard deviation for each replicate data set when compared to mean cytokine production for LPS-treated cultures in the absence of test product.

Figure 8 shows the change in RANTES (stimulated modulation, normal T cell expression and secretion) levels in supernatants of PBMC cultures treated with serial dilutions of the test products in the presence of bacterial Lipopolysaccharide (LPS) for 24 hours. Data are shown as group mean plus or minus standard deviation for each replicate data set when compared to mean cytokine production for LPS-treated cultures in the absence of test product.

FIG. 9 shows the change in IP-10 levels in supernatants of PBMC cultures treated with serial dilutions of the test product for 24 hours in the presence of bacterial Lipopolysaccharide (LPS). Data are shown as group mean plus or minus standard deviation for each replicate data set when compared to mean cytokine production for LPS-treated cultures in the absence of test product.

FIG. 10 shows the change in IL-2 levels in supernatants of PBMC cultures treated with serial dilutions of the test product for 24 hours in the presence of bacterial Lipopolysaccharide (LPS). Data are shown as group mean plus or minus standard deviation for each replicate data set when compared to mean cytokine production for LPS-treated cultures in the absence of test product.

FIG. 11 shows changes in mitochondrial function in PBMC cultures treated with serial dilutions of test product in the presence of bacterial Lipopolysaccharide (LPS) for 24 hours. Data are shown as group mean plus or minus standard deviation for each replicate data set when compared to mean cytokine production for LPS-treated cultures in the absence of test product.

Figure 12 shows the increase in forced swimming time achieved by rats subjected to the protocol of example 4. The increased forced swimming time was measured after application of a maca composition comprising black maca and red maca in a ratio of 4: a ratio of 1 is present.

FIG. 13 shows the decrease in NF- κ B measured in rats in the protocol of example 4. The reduction in NF- κ B was measured after application of a maca composition comprising black maca and red maca, wherein the black maca and red maca are mixed at a ratio of 4: a ratio of 1 is present.

FIG. 14 shows the increase in SIRT-1 measured in rats in the protocol of example 4. The increase in SIRT-1 was measured after applying a maca composition comprising black maca and red maca, wherein the black maca and red maca were mixed at a ratio of 4: a ratio of 1 is present.

FIG. 15 shows the increase in mitochondrial Transcription Factor A (TFAM) measured in rats in the protocol of example 4. The increase in TFAM was measured after application of a maca composition comprising black maca and red maca, wherein the black maca and red maca are mixed at a ratio of 4: a ratio of 1 is present.

FIG. 16 shows the increase in nuclear respiratory factor 1(Nrf-1) measured in rats in the protocol of example 4. The increase in Nrf-1 was measured after application of a maca composition comprising black maca and red maca, wherein the black maca and red maca are mixed at a ratio of 4: a ratio of 1 is present.

FIG. 17 shows the increase of the nuclear factor erythroid 2(Nrf-2) measured in rats in the protocol of example 4. The increase in Nrf-2 was measured after application of a maca composition comprising black maca and red maca, wherein the black maca and red maca were mixed at a ratio of 4: a ratio of 1 is present.

FIG. 18 shows the increase of peroxisome proliferator activated receptor- γ coactivator (PGC-1) measured in rats in the protocol of example 4. The increase in PGC-1 activity was measured after administration of a maca composition comprising black maca and red maca, wherein the black maca and red maca are mixed at a ratio of 4: a ratio of 1 is present.

Detailed Description

Definition of

The terminology used in the description presented herein is not intended to be interpreted in any limited or restrictive manner, simply because it is being utilized in conjunction with a detailed description of certain specific embodiments described herein. Furthermore, the embodiments described herein may include several novel features, no single one of which is solely responsible for its desirable attributes or which is essential to practicing the inventions herein described. The meanings of the various terms and phrases used herein are to be interpreted illustratively as follows. Note that the precise meaning of a particular term or phrase can vary depending upon the context in which it is used.

Embodiments disclosed herein relate to the use of a composition comprising, consisting essentially of, or consisting of maca root powder. The maca root may be provided as red maca, yellow maca or black maca or combinations thereof, including pharmaceutically acceptable salts, hydrates, solvates or mixtures thereof, for use in the treatment or prevention of an inflammatory disorder.

The term "treating" or "treatment" does not necessarily mean a complete cure. Alleviating any undesired signs or symptoms of disease, or slowing the progression, or even preventing the disease or disorder to any extent, can be considered as a treatment. As used herein, the term "providing" (a substance) refers to supplying, causing or administering the substance. As used herein, the term "subject" includes animals, preferably mammals, and most preferably humans. The term "subject" is used interchangeably with "patient".

Some embodiments provide compositions comprising, consisting essentially of, or consisting of an effective amount of maca and methods of treating a subject with a composition. Some embodiments provide compositions and methods of treating a subject with a composition comprising, consisting essentially of, or consisting of an effective amount of maca and an effective amount of a second agent.

As used herein, "maca composition" generally refers to a composition comprising at least two different maca root phenotypes (although in certain embodiments it may refer to a single maca root phenotype), wherein the different phenotypes are specifically represented by different colors resulting from specific compositional characteristics. Examples of maca compositions with different phenotypes include, but are not limited to, yellow and black, black and red, and red and yellow. In some aspects, the maca compositions may comprise different maca root phenotypes provided in different molar, weight, or volume ratios. Maca compositions may include a proportion of red, black, purple, green, yellow, blue maca root phenotypes and combinations thereof, which proportions may be contemplated by one of skill in the art in light of the disclosure contained herein.

As used herein, the term "sexual dysfunction" refers to the difficulty that a subject encounters during any phase of normal sexual activity, including, but not limited to, physical pleasure, desire, preference, arousal, or orgasm. Sexual dysfunction also includes desire disorder-lack of libido or interest in sex; arousal disorder-inability to be aroused or excited by the body during sexual activity; orgasm disorder-delayed or no orgasm (orgasm); and pain disorder-pain during intercourse.

Identifying an individual having or in need of treatment for sexual dysfunction or symptoms thereof can include, for example, identifying one or more of the following Disorders according to the fourth edition of Diagnostic and Statistical Manual of Mental Disorders: hypoactive sexual desire disorder, sexual aversion disorder, female sexual arousal disorder, male erectile disorder, female orgasmic disorder, male orgasmic disorder, sexual dysfunction, dyspareunia, and/or vaginismus. Identifying an individual having or in need of treatment for sexual dysfunction or a symptom thereof can be performed by or with the aid of a medical professional. In some aspects, identifying an individual having or in need of treatment for sexual dysfunction or a symptom thereof comprises self-identification of the patient.

As used herein, the term "libido" refers to the overall libido or desire for sexual activity of a subject. Subjects in need of increased libido may include persons diagnosed with or self-diagnosed with one or more sexual dysfunction or disorder.

As used herein, the term "mitochondrial function" refers to the ability of the mitochondria of a subject to synthesize Adenosine Triphosphate (ATP), measured and determined by methods known to those skilled in the art.

As used herein, "effective amount" includes within its meaning a non-toxic but sufficient amount of the compound active ingredient or composition comprising the same, for use in the embodiments disclosed herein to provide the desired therapeutic effect. The exact amount of active ingredient disclosed herein that is required will vary from subject to subject, depending on factors such as the species being treated, the age and general condition of the subject, the severity of the condition being treated, the particular agent being administered, the weight of the subject and the mode of administration. Thus, embodiments may not specify an exact "effective amount". For any particular case; those skilled in the art can envision an appropriate "effective amount" based on the terminology and the context of the disclosure contained herein.

The term "physical activity" as used herein may refer to exercise such as, but not limited to, anaerobic exercise, aerobic exercise, weight lifting, cross training, athletic competitions, tasks involving muscle movement (e.g., physical labor), and the like, as well as combinations of these. As used herein, "physical activity" may refer to such activities undertaken by a mammal (e.g., a human). "physical activity" may also refer to an undesirable effect experienced by a mammal (e.g., a human) shortly after the activity in this paragraph. The meaning and scope of this term will be immediately envisaged by the skilled person when considering the scope of its use.

In some aspects, an "effective amount" of total maca roots provided in one, two or more maca phenotypes disclosed herein can be, for example, 1mg/kg, 2mg/kg, 3mg/kg, 4mg/kg, 5mg/kg, 6mg/kg, 7mg/kg, 8mg/kg, 9mg/kg, 10mg/kg, 15mg/kg, 20mg/kg, 25mg/kg, 30mg/kg, 35mg/kg, 40mg/kg, 45mg/kg, 50mg/kg, 55mg/kg, 60mg/kg, 65mg/kg, 70mg/kg, 75mg/kg, 80mg/kg, 85mg/kg, 90mg/kg, 95mg/kg, 100mg/kg, 105mg/kg, 110mg/kg, 115mg/kg, or, 120mg/kg, 125mg/kg, 130mg/kg, 135mg/kg, 140mg/kg, 145mg/kg, 150mg/kg, 155mg/kg, 160mg/kg, 165mg/kg, 170mg/kg, 175mg/kg, 180mg/kg, 185mg/kg, 190mg/kg, 195mg/kg, 200mg/kg or more, or any amount therebetween. Thus, in some embodiments, an effective amount of total maca root in a composition disclosed herein may be (preferably daily) from about 1mg to about 5 g. For example, the amount of total maca root may be 1mg, 10mg, 100mg, 500mg, 1g, 1.5g, 2g, 2.5g, 3g, 3.5g, 4g, 4.5g, or 5g or more, or any range or amount between any two of the foregoing values. In some aspects, an "effective amount" of total maca roots is about 3 grams of maca roots per person per day, provided to an individual in two or more maca phenotypes, regardless of the individual's weight.

For example, an "effective amount" of black maca root disclosed herein can be, e.g., 1mg/kg, 2mg/kg, 3mg/kg, 4mg/kg, 5mg/kg, 6mg/kg, 7mg/kg, 8mg/kg, 9mg/kg, 10mg/kg, 15mg/kg, 20mg/kg, 25mg/kg, 30mg/kg, 35mg/kg, 40mg/kg, 45mg/kg, 50mg/kg, 55mg/kg, 60mg/kg, 65mg/kg, 70mg/kg, 75mg/kg, 80mg/kg, 85mg/kg, 90mg/kg, 95mg/kg, 100mg/kg, 105mg/kg, 110mg/kg, 115mg/kg, 120mg/kg, 125mg/kg, 130mg/kg, 135mg/kg, 140mg/kg, 145mg/kg, 150mg/kg, 155mg/kg, 160mg/kg, 165mg/kg, 170mg/kg, 175mg/kg, 180mg/kg, 185mg/kg, 190mg/kg, 195mg/kg, 200mg/kg or more, or any amount therebetween. Thus, in some embodiments, an effective amount of maca root in a composition disclosed herein may be (preferably daily) from about 1mg to about 5 g. For example, the amount of maca root can be 1mg, 10mg, 100mg, 500mg, 1g, 1.5g, 2g, 2.5g, 3g, 3.5g, 4g, 4.5g, or 5g or more, or any range or amount between any two of the foregoing values.

For example, an "effective amount" of red maca root disclosed herein can be, e.g., 1mg/kg, 2mg/kg, 3mg/kg, 4mg/kg, 5mg/kg, 6mg/kg, 7mg/kg, 8mg/kg, 9mg/kg, 10mg/kg, 15mg/kg, 20mg/kg, 25mg/kg, 30mg/kg, 35mg/kg, 40mg/kg, 45mg/kg, 50mg/kg, 55mg/kg, 60mg/kg, 65mg/kg, 70mg/kg, 75mg/kg, 80mg/kg, 85mg/kg, 90mg/kg, 95mg/kg, 100mg/kg, 105mg/kg, 110mg/kg, 115mg/kg, 120mg/kg, 125mg/kg, 130mg/kg, 135mg/kg, 140mg/kg, 145mg/kg, 150mg/kg, 155mg/kg, 160mg/kg, 165mg/kg, 170mg/kg, 175mg/kg, 180mg/kg, 185mg/kg, 190mg/kg, 195mg/kg, 200mg/kg or more, or any amount therebetween. Thus, in some embodiments, an effective amount of red maca root in a composition disclosed herein may be (preferably daily) from about 1mg to about 5 g. For example, the amount of red maca root may be (preferably daily) from about 1mg to about 5 g. For example, the amount of red maca root may be 1mg, 10mg, 100mg, 500mg, 1g, 1.5g, 2g, 2.5g, 3g, 3.5g, 4g, 4.5g, or 5 g. Or more, or any range or amount between any two of the preceding values.

For example, an "effective amount" of the root of Xanthomonas disclosed herein can be, e.g., 1mg/kg, 2mg/kg, 3mg/kg, 4mg/kg, 5mg/kg, 6mg/kg, 7mg/kg, 8mg/kg, 9mg/kg, 10mg/kg, 15mg/kg, 20mg/kg, 25mg/kg, 30mg/kg, 35mg/kg, 40mg/kg, 45mg/kg, 50mg/kg, 55mg/kg, 60mg/kg, 65mg/kg, 70mg/kg, 75mg/kg, 80mg/kg, 85mg/kg, 90mg/kg, 95mg/kg, 100mg/kg, 105mg/kg, 110mg/kg, 115mg/kg, 120mg/kg, 125mg/kg, 130mg/kg, 135mg/kg, 140mg/kg, 145mg/kg, 150mg/kg, 155mg/kg, 160mg/kg, 165mg/kg, 170mg/kg, 175mg/kg, 180mg/kg, 185mg/kg, 190mg/kg, 195mg/kg, 200mg/kg or more, or any amount therebetween. Thus, in some embodiments, an effective amount of the root of maca in the compositions disclosed herein may be (preferably daily) from about 1mg to about 5 g. For example, the amount of root of maca may be (preferably daily) from about 1mg to about 5 g. For example, the amount of the root of maca may be 1mg, 10mg, 100mg, 500mg, 1g, 1.5g, 2g, 2.5g, 3g, 3.5g, 4g, 4.5g, or 5g or more, or any range or amount between any two of the foregoing values.

For example, an "effective amount" of a root of Bluemaca disclosed herein can be, e.g., 1mg/kg, 2mg/kg, 3mg/kg, 4mg/kg, 5mg/kg, 6mg/kg, 7mg/kg, 8mg/kg, 9mg/kg, 10mg/kg, 15mg/kg, 20mg/kg, 25mg/kg, 30mg/kg, 35mg/kg, 40mg/kg, 45mg/kg, 50mg/kg, 55mg/kg, 60mg/kg, 65mg/kg, 70mg/kg, 75mg/kg, 80mg/kg, 85mg/kg, 90mg/kg, 95mg/kg, 100mg/kg, 105mg/kg, 110mg/kg, 115mg/kg, 120mg/kg, 125mg/kg, 130mg/kg, 135mg/kg, 140mg/kg, 145mg/kg, 150mg/kg, 155mg/kg, 160mg/kg, 165mg/kg, 170mg/kg, 175mg/kg, 180mg/kg, 185mg/kg, 190mg/kg, 195mg/kg, 200mg/kg or more, or any amount therebetween. Thus, in some embodiments, an effective amount of blue maca root in a composition disclosed herein may be (preferably daily) from about 1mg to about 5 g. For example, the amount of blue maca root may be (preferably daily) from about 1mg to about 5 g. For example, the amount of blue maca root may be 1mg, 10mg, 100mg, 500mg, 1g, 1.5g, 2g, 2.5g, 3g, 3.5g, 4g, 4.5g, or 5g or more, or any range or amount between any two of the foregoing values.

For example, an "effective amount" of purple maca root disclosed herein can be, e.g., 1mg/kg, 2mg/kg, 3mg/kg, 4mg/kg, 5mg/kg, 6mg/kg, 7mg/kg, 8mg/kg, 9mg/kg, 10mg/kg, 15mg/kg, 20mg/kg, 25mg/kg, 30mg/kg, 35mg/kg, 40mg/kg, 45mg/kg, 50mg/kg, 55mg/kg, 60mg/kg, 65mg/kg, 70mg/kg, 75mg/kg, 80mg/kg, 85mg/kg, 90mg/kg, 95mg/kg, 100mg/kg, 105mg/kg, 110mg/kg, 115mg/kg, 120mg/kg, 125mg/kg, 130mg/kg, 135mg/kg, 140mg/kg, 145mg/kg, 150mg/kg, 155mg/kg, 160mg/kg, 165mg/kg, 170mg/kg, 175mg/kg, 180mg/kg, 185mg/kg, 190mg/kg, 195mg/kg, 200mg/kg or more, or any amount therebetween. Thus, in some embodiments, an effective amount of the purple mahima root in the compositions disclosed herein may be (preferably daily) from about 1mg to about 5 g. For example, the amount of purple maca root may be (preferably daily) from about 1mg to about 5 g. For example, the amount of purple maca root may be 1mg, 10mg, 100mg, 500mg, 1g, 1.5g, 2g, 2.5g, 3g, 3.5g, 4g, 4.5g, or 5g or more, or any range or amount between any two of the foregoing values.

For example, an "effective amount" of a green maca root disclosed herein can be, e.g., 1mg/kg, 2mg/kg, 3mg/kg, 4mg/kg, 5mg/kg, 6mg/kg, 7mg/kg, 8mg/kg, 9mg/kg, 10mg/kg, 15mg/kg, 20mg/kg, 25mg/kg, 30mg/kg, 35mg/kg, 40mg/kg, 45mg/kg, 50mg/kg, 55mg/kg, 60mg/kg, 65mg/kg, 70mg/kg, 75mg/kg, 80mg/kg, 85mg/kg, 90mg/kg, 95mg/kg, 100mg/kg, 105mg/kg, 110mg/kg, 115mg/kg, 120mg/kg, 125mg/kg, 130mg/kg, 135mg/kg, 140mg/kg, 145mg/kg, 150mg/kg, 155mg/kg, 160mg/kg, 165mg/kg, 170mg/kg, 175mg/kg, 180mg/kg, 185mg/kg, 190mg/kg, 195mg/kg, 200mg/kg or more, or any amount therebetween. Thus, in some embodiments, an effective amount of green maca root in a composition disclosed herein may be (preferably daily) from about 1mg to about 5 g. For example, the amount of green maca root may be (preferably daily) from about 1mg to about 5 g. For example, the amount of green maca root may be 1mg, 10mg, 100mg, 500mg, 1g, 1.5g, 2g, 2.5g, 3g, 3.5g, 4g, 4.5g, or 5g or more, or any range or amount between any two of the foregoing values.

In some embodiments, examples of therapeutically effective amounts listed above may be administered on an hourly basis, e.g., each, two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, sixteen, seventeen, eighteen, nineteen, twenty-one, twenty-two, twenty-three hours, or any interval therebetween, or on a daily, every two days, every three days, every four days, every five days, every six days, weekly, every eight days, every nine days, every ten days, every two weeks, every month, or more or less frequent basis as described elsewhere herein, to achieve a desired therapeutic effect, as desired.

As used herein, "second agent" refers to an additional active compound or compounds (i.e., not an excipient, diluent, or carrier). Exemplary second agents include vitamins, minerals, hormones, non-steroidal anti-inflammatory drugs, and antidepressants.

In some embodiments, the maca composition is provided in combination with a second agent, e.g., within a single dosage form (e.g., a single oral dosage form or an oral suspension dosage form). In some embodiments, the maca composition and the second agent are provided in a multiple unit dosage form. In some embodiments, the maca composition is suspended in a solution of the second agent. Thus, provided herein are compositions comprising, consisting essentially of, or consisting of maca and a second agent.

The terms "macamide" and "macaene (macamene)" as used herein refer to a specific class of compounds found in maca root.

The term "physiologically acceptable" defines a carrier, diluent or excipient that does not abrogate the biological activity and properties of the compound.

As used herein, "carrier" refers to a compound that facilitates incorporation of the compound into a cell or tissue. For example, but not limited to, dimethyl sulfoxide (DMSO) is a commonly used carrier that aids in the uptake of many organic compounds into cells or tissues of a subject.

As used herein, "diluent" refers to an ingredient in a composition that lacks pharmacological activity but may be pharmaceutically necessary or desirable. For example, diluents may be used to increase the volume of effective drug that is too small in mass to be manufactured and/or administered. It may also be a dissolved liquid for a drug to be administered by injection, ingestion or inhalation. A common form of diluent in the art is an aqueous buffered solution such as, but not limited to, phosphate buffered saline that mimics the composition of human blood.

As used herein, "excipient" refers to an inert substance added to a pharmaceutical composition to provide, but not limited to, bulk, consistency, stability, binding capacity, lubrication, disintegration capacity, and the like to the composition. A "diluent" is one of the excipients.

The pharmaceutical compositions disclosed herein may be manufactured in a manner that is itself known, e.g., by means of conventional mixing, dissolving, granulating, dragee-making, levigating, emulsifying, encapsulating, entrapping or tableting processes. In addition, the active ingredient is included in an effective amount to achieve its intended purpose. Many of the compounds used in the pharmaceutical combinations disclosed herein can be provided as salts with pharmaceutically compatible counterions.

There are a variety of techniques in the art for administering compounds, including, but not limited to, oral, rectal, topical, aerosol, injection, and parenteral delivery, including intramuscular, subcutaneous, intravenous, intramedullary injections, intrathecal, direct intraventricular, intraperitoneal, intranasal, and intraocular injections.

Some embodiments provide maca compositions comprising at least two maca root phenotypes. Some embodiments provide maca compositions comprising at least three maca root phenotypes. Some embodiments provide maca compositions comprising at least four maca root phenotypes. Some embodiments provide maca compositions comprising at least five maca root phenotypes. Some embodiments provide maca compositions comprising two, three, four or five maca root phenotypes.

In some embodiments, the composition comprises an effective amount of black maca and an effective amount of yellow maca. In some embodiments, the composition comprises an effective amount of black maca and an effective amount of red maca. In some embodiments, the composition comprises an effective amount of black maca and an effective amount of purple maca. In some embodiments, the composition comprises an effective amount of black maca and an effective amount of green maca. In some embodiments, the composition comprises an effective amount of black maca and an effective amount of blue maca.

In some embodiments, the composition comprises an effective amount of red maca and an effective amount of yellow maca. In some embodiments, the composition comprises an effective amount of red maca and an effective amount of green maca. In some embodiments, the composition comprises an effective amount of red maca and an effective amount of purple maca. In some embodiments, the composition comprises an effective amount of red maca and an effective amount of blue maca.

In some embodiments, the composition comprises an effective amount of red maca, an effective amount of yellow maca, and an effective amount of black maca.

In some embodiments, the maca root phenotype is present in the following ratio: 1: 1. 1: 2. 1: 3. 1: 4. 1: 5. 1: 6. 1: 7. 1: 8. 1: 9. 1: 10. 1: 15. 1: 20. 1: 30. 1: 40. 1: 50. 1: 1: 1. 1: 1: 2. 1: 1: 3. 1: 1: 4. 1: 1: 5. 1: 1: 6. 1: 1: 7. 1: 1: 8. 1: 1: 9. 1: 1: 10. 1: 2: 1. 1: 2: 2. 1: 2: 3. 1: 2: 4. 1: 2: 5. 1: 2: 6. 1: 2: 7. 1: 2: 8. 1: 2: 9. 1: 2: 10. 1: 3: 1. 1: 3: 2. 1: 3: 3. 1: 3: 4. 1: 3: 5. 1: 3: 6. 1: 3: 7. 1: 3: 8. 1: 3: 9. 1: 3: 10. 1: 4: 1. 1: 4: 2. 1: 4: 3. 1: 4: 4. 1: 4: 5. 1: 4: 6. 1: 4: 7. 1: 4: 8. 1: 4: 9. 1: 4: 10. 1: 5: 1. 1: 5: 2. 1: 5: 3. 1: 5: 4. 1: 5: 5. 1: 5: 6. 1: 5: 7. 1: 5: 8. 1: 5: 9. 1: 5: 10. 1: 6: 1. 1: 6: 2. 1: 6: 3. 1: 6: 4. 1: 6: 5. 1: 6: 6. 1: 6: 7. 1: 6: 8. 1: 6: 9. 1: 6: 10. 1: 7: 1. 1: 7: 2. 1: 7: 3. 1: 7: 4. 1: 7: 5. 1: 7: 6. 1: 7: 7. 1: 7: 8. 1: 7: 9. 1: 7: 10. 1: 8: 1. 1: 8: 2. 1: 8: 3. 1: 8: 4. 1: 8: 5. 1: 8: 6. 1: 8: 7. 1: 8: 8. 1: 8: 9. 1: 8: 10. 1: 9: 1. 1: 9: 2. 1: 9: 3. 1: 9: 4. 1: 9: 5. 1: 9: 6. 1: 9: 7. 1: 9: 8. 1: 9: 9. 1: 9: 10. 1: 10: 1. 1: 10: 2. 1: 10: 3. 1: 10: 4. 1: 10: 5. 1: 10: 6. 1: 10: 7. 1: 10: 8. 1: 109: 9. 1: 10: 10, or any ratio therebetween.

In some embodiments, the maca composition comprises 1: 1 black-red maca root. In some embodiments, the maca composition comprises 2: 1 black-red maca root. In some embodiments, the maca composition comprises 4:1 black-red maca root. In some embodiments, the maca composition comprises 1: 4 black-red maca root. In some embodiments, the maca composition comprises 1: 1 black-yellow maca root. In some embodiments, the maca composition comprises 1: 1 yellow-red maca root.

If desired, the compositions may be presented in a pack or dispenser device which may contain one or more unit dosage forms containing the active ingredient. The package may for example comprise a metal or plastic foil, such as a blister pack. The pack or dispenser device may be accompanied by instructions for administration. The package or dispenser may also be accompanied by a container-related notice in a form prescribed by a governmental agency regulating the manufacture, use or sale of pharmaceuticals, which notice is reflective of approval by the agency of the form of the drug for human or veterinary administration. For example, such a notification may be a label approved by the U.S. food and drug administration for prescription drugs or an approved product insert. Compositions may also be prepared that may contain a compound described herein formulated in a compatible pharmaceutical carrier, placed in a suitable container, and labeled for treatment of a designated condition.

In some embodiments, the compositions provided herein are formulated for intradermal, intramuscular, intraperitoneal, intravenous, subcutaneous, intranasal, epidural, oral, sublingual, intranasal, intracerebral, intravaginal, transdermal, rectal, ophthalmic, or topical delivery. The preferred mode of administration is at the discretion of the physician and will depend in part on the site of the medical condition. In most cases, administration will result in the release of the compounds of the embodiments disclosed herein into the bloodstream.

In some embodiments, the compositions provided herein comprise, consist essentially of, or consist of an effective amount of a combination of maca, which may be any one or combination of the phenotypes described herein. In embodiments, the compositions provided herein comprise, consist essentially of, or consist of a synergistically effective amount of a combination of macas, which may be any one or combination of the phenotypes described herein.

In some embodiments, maca is provided with a nutritionally acceptable carrier or a pharmaceutically acceptable carrier. As used herein, the phrase "nutritionally acceptable carrier," "nutritionally acceptable excipient," "pharmaceutically acceptable carrier," or "pharmaceutically acceptable excipient" refers to a nutritionally or pharmaceutically acceptable material, composition, or carrier suitable for administering the compounds of the embodiments disclosed herein to a mammal. Carriers may include liquid or solid fillers, diluents, excipients, solvents, or encapsulating materials involved in carrying or transporting an agent of interest from one organ or part of the body to another organ or part of the body. The carrier may be "acceptable" in the sense of being compatible with the other ingredients of the formulation and not injurious to the patient. Some examples of materials that can be used as a nutritionally or pharmaceutically acceptable carrier include, but are not limited to: sugars such as lactose, glucose and sucrose; starches, such as corn starch and potato starch; cellulose and its derivatives, such as sodium carboxymethyl cellulose, ethyl cellulose and cellulose acetate; powdered tragacanth; malt; gelatin; talc; excipients, such as cocoa butter and suppository waxes; oils such as peanut oil, cottonseed oil, safflower oil, sesame oil, olive oil, corn oil and soybean oil; glycols, such as propylene glycol; polyols such as glycerol, sorbitol, mannitol and polyethylene glycol; esters, such as ethyl oleate and ethyl laurate; agar; buffering agents such as magnesium hydroxide and aluminum hydroxide; alginic acid; pyrogen-free water; isotonic saline; ringer solution; ethanol; phosphate buffer; and other non-toxic compatible materials used in pharmaceutical formulations. In some embodiments, the nutritionally or pharmaceutically acceptable carrier may be suitable for intravenous administration. In some embodiments, the nutritionally or pharmaceutically acceptable carrier may be suitable for local area injection.

The term "composition" refers to a pharmaceutically and nutritionally acceptable formulation, and includes formulations suitable for administration to a subject (e.g., a human). When the compounds of the embodiments disclosed herein are administered to a subject (e.g., a human), they may be administered alone or as a composition containing, for example, 0.1 to 99.5% (more preferably 0.5 to 90%) of the active ingredient in association with a nutritionally or pharmaceutically acceptable carrier. The amount of active agent incorporated into the multiple unit dosage forms of the embodiments disclosed herein is an amount sufficient to achieve the desired effect.

For oral administration, the compositions disclosed herein may be provided as tablets, aqueous or oily suspensions, dispersible powders or granules, emulsions, hard or soft capsules, syrups, elixirs, chews or beverages. Solid dosage forms such as tablets and capsules may comprise an enteric coating. Compositions for oral use may be prepared according to any method known in the art for preparing compositions, and such compositions may include one or more of the following agents: sweetening agents, flavouring agents, colouring agents, coating agents and preserving agents. Sweetening agents and flavouring agents will increase the palatability of the formulation. Tablets containing the complex are acceptable in admixture with non-toxic pharmaceutically acceptable excipients suitable for tablet manufacture. Pharmaceutically acceptable carriers (e.g., excipients) are compatible with the other ingredients of the formulation (and not deleterious to the patient). Such excipients include inert diluents such as calcium carbonate, sodium carbonate, lactose, calcium phosphate or sodium phosphate; granulating and disintegrating agents, such as corn starch or alginic acid; binding agents such as starch, gelatin or acacia; and lubricating agents, such as magnesium stearate, stearic acid or talc. Tablets may be uncoated or they may be coated by known techniques to delay disintegration and absorption in the gastrointestinal tract and thereby provide a sustained action over a longer period. For example, a time delay material (e.g., glyceryl monostearate or glyceryl distearate) may be employed alone or with a wax.

Formulations for oral use may also be presented as hard gelatin or non-gelatinous capsules wherein the active ingredient is mixed with an inert solid diluent, for example calcium carbonate, calcium phosphate or kaolin, or as soft gelatin capsules wherein the active ingredient is mixed with water or an oil medium, for example peanut oil, liquid paraffin or olive oil. Aqueous suspensions may contain the complexes described herein in admixture with excipients suitable for the manufacture of aqueous suspensions. Such excipients include suspending agents, dispersing or wetting agents, one or more preservatives, one or more coloring agents, one or more flavoring agents, and one or more sweetening agents (e.g., sucrose or saccharin).

Chewable dosage forms can be made with a candy base such as rice syrup, maltitol syrup, sugar/corn syrup, and the like. The matrix may be sugar or sugarless. Additives such as palm oil, sunflower oil, soy lecithin and glycerin may be included to formulate the chewable. The chewable agent may be flavored with natural and/or artificial flavors.

Oil suspensions may be formulated by suspending the active ingredient in a vegetable oil, for example arachis oil, olive oil, sesame oil or coconut oil, or in a mineral oil such as liquid paraffin. The oil suspension may contain a thickening agent, for example beeswax, hard paraffin or cetyl alcohol. Sweetening agents, such as those set forth above, and flavoring agents may be added to provide a palatable oral preparation. These compositions may be preserved by the addition of an antioxidant such as ascorbic acid. Dispersible powders and granules suitable for preparation of an aqueous suspension by the addition of water provide the active ingredient in admixture with a dispersing or wetting agent, suspending agent and one or more preservatives. Additional excipients, for example sweetening, flavoring and coloring agents, may also be present.

Syrups and elixirs may be formulated with sweetening agents, for example glycerol, sorbitol or sucrose. Such formulations may also contain a demulcent, a preservative, a flavoring or a coloring agent.

It is understood that the amount of the compound can be combined with a carrier material to produce a single dosage form. These dosage forms will vary depending upon the host treated and the particular mode of administration.

The compositions disclosed herein are administered in isolated form or in isolated form in a therapeutic composition when administered to a subject, for example to an animal for veterinary use or for improving livestock, or to a human for therapeutic use. As used herein, "isolated" refers to the separation of a composition disclosed herein from (a) a natural source (e.g., plant or cell or food, preferably bacterial culture) or (b) other components of a synthetic organic chemical reaction mixture. Preferably, the compositions disclosed herein are purified by conventional techniques. As used herein, "purified" means that when isolated, the isolate contains at least 95%, preferably at least 98%, of the composition.

Aqueous suspensions may contain the compounds disclosed herein in admixture with excipients suitable for the manufacture of aqueous suspensions. Such excipients include suspending agents, dispersing or wetting agents, one or more preservatives, one or more coloring agents, one or more flavoring agents, and one or more sweetening agents (e.g., sucrose or saccharin).

Controlled release carriers are well known to those skilled in the art of pharmaceutical science. The techniques and products of the art are variably referred to as controlled release, sustained release, extended action, depot (depot), delayed action, delayed release and timed release; the word "controlled release" as used herein is intended to combine each of the foregoing techniques.

Many controlled release carriers are known, including biodegradable or bioerodible (bioerodable) polymers such as polylactic acid, polyglycolic acid, and regenerated collagen. Known controlled release drug delivery devices include creams, lotions, tablets, capsules, gels, microspheres, liposomes, ophthalmic inserts, micro-pumps and other infusion devices (e.g., pumps and syringes). Implantable or injectable polymer matrices and transdermal formulations in which the active ingredient is slowly released are also well known and may be used in the disclosed methods.

Controlled release formulations may be achieved by using polymers to form a complex with or absorb maca. Controlled delivery can be achieved by selecting suitable macromolecules such as polyesters, polyamino acids, polyvinylpyrrolidone, ethylene vinyl acetate, methylcellulose, carboxymethylcellulose, and protamine sulfate, and selecting the concentration of these macromolecules and the method of incorporation to control the release of the active complex.

Controlled release of the active complex may be considered to refer to any extended release dosage form. For the purposes of this disclosure, the following terms may be considered to be substantially equivalent to controlled release: continuous release, controlled release, delayed release, depot (depot), gradual release, extended release, programmed release, proper release, sustained release, depot (depot), delayed, sustained release, interval release, sustained release, timed coating, timed release, delayed action, extended action, stratified time action, long acting, extended action, sustained action drug and extended release, based on pH levels in the intestinal and digestive tract, breakdown of molecules and release based on absorption and bioavailability.

Hydrogels can be prepared by copolymerization of hydrophilic monoolefin monomers (e.g., ethylene glycol methacrylate) in which maca powder is dissolved in an aqueous component for gradual release over time. A matrix device may be used in which maca powder is dispersed in a matrix of carrier material. The carrier may be porous, non-porous, solid, semi-solid, permeable or impermeable. Alternatively, a device containing a central reservoir of maca powder surrounded by a rate controlling membrane may be used to control the release of the composite. The rate controlling membrane comprises an ethylene vinyl acetate copolymer or butylene terephthalate/polyethylene terephthalate. The use of silicone rubber or ethylene vinyl alcohol reservoirs is also contemplated.

Controlled release oral formulations are also well known. In one embodiment, the active complex is incorporated into a soluble or erodible matrix, such as a pill or lozenge. In another example, the oral formulation may be a liquid for sublingual administration. These liquid compositions may also be in the form of gels or pastes. Hydrophilic gums, such as hydroxymethylcellulose, are commonly used. Lubricants such as magnesium stearate, stearic acid or calcium stearate may be used to assist the tableting process.

Embodiments of the compositions described herein may be administered once, twice or three times daily. In some aspects, the composition is administered four times per day. For example, the composition may be administered before, after or during a meal. The dose for oral administration may be a regimen requiring a single daily dose, or once every other day dose, or a single dose within 72 hours of the first administered dose, or multiple spaced doses throughout the day. The active agents that may constitute a treatment may be administered simultaneously in a combined dosage form or separate dosage forms for substantially simultaneous oral administration. The active agents that make up the treatment may also be administered sequentially, with either active ingredient being administered by a regimen that requires two-step ingestion. Thus, the regimen may require sequential administration of the active agents by ingestion of the individual active agents at intervals. The time period between the multiple ingestion steps may range from several minutes up to about 72 hours, depending on the nature of each active agent, such as the potency, solubility, bioavailability, plasma half-life and kinetic characteristics of the agent, and on the age and condition of the patient. Therapeutically active agents, whether administered simultaneously, substantially simultaneously, or sequentially, may include regimens that require administration of one active agent by the oral route and the other active agent by the intravenous route. Whether the therapeutically active agents are administered by oral or intravenous routes, separately or together, each such active agent will be contained in a suitable pharmaceutical formulation of a pharmaceutically acceptable excipient, diluent or other formulation component.

The active ingredients (e.g., maca root and other pharmaceutical or supplemental ingredients, if present) may be administered by the oral route in solid dosage forms (e.g., tablets, capsules, and powders) or in liquid dosage forms (e.g., elixirs, syrups, and suspensions). Each active ingredient may be administered in liquid dosage form by parenteral route. The pharmaceutical compositions are preferably prepared in the form of dosage units containing specific amounts of each active ingredient.

In general, Pharmaceutical dosage forms of The compositions of The present application can be prepared by conventional techniques, such as Remington's Pharmaceutical Sciences, a standard reference in The art [ Gennaro AR, Ed. Remington: The Science and Practice of pharmacy.20th edition.Baltimore: Lippincott, Williams & Williams,2000 ]. For therapeutic purposes, the active ingredients of the combination therapy are usually combined with one or more adjuvants appropriate for the indicated route of administration. The components may be mixed with lactose, sucrose, starch powder, cellulose esters of alkanoic acids, cellulose alkyl esters, talc, stearic acid, magnesium stearate, gelatin, acacia, sodium alginate, polyvinylpyrrolidone and/or polyvinyl alcohol and then made into tablets, or enclosed in capsules for convenient administration. Such capsules or tablets may contain a controlled release formulation, which may be provided as a dispersion of the active compound in hydroxypropylmethylcellulose. Solid dosage forms can be made as sustained release products to continuously release drug over several hours. Compressed tablets may be sugar-coated or film-coated to mask any unpleasant taste and protect the tablet from the atmosphere, or enteric-coated to selectively disintegrate in the gastrointestinal tract. Both solid and liquid oral dosage forms may contain coloring and flavoring agents to increase patient acceptance. Other adjuvants and modes of administration are well known in the pharmaceutical art.

The compositions disclosed herein may preferably be formulated with other active ingredients (e.g., a slow or long acting agent in addition to the drug) before and/or after a meal, or formulated separately. Effective doses can be extrapolated from dose-response curves derived from in vitro or animal model test systems. These animal models and systems are well known in the art.

Synergistic composition of maca root

In some embodiments, the compositions provided herein comprise synergistically effective amounts of maca phenotypes selected together to provide a greater than additive effect. This greater than additive effect may include, but is not limited to, increased libido and/or decreased systemic inflammation. As used herein, "synergistically effective amounts" refer to the amount of one component of a composition necessary to produce a synergistic effect with another component present in the composition. As used herein, "synergistic effect" means unexpectedly superior to the results expected when either component is administered alone. The exact synergistically effective amounts of the active ingredients disclosed herein required will vary from subject to subject, depending on the following factors: such as the species being treated, the age and general condition of the subject, the complications, the severity of the condition being treated, the particular agent being administered, the weight and mode of administration of the subject, and the like. Thus, embodiments may not specify an exact "synergistic amount". However, for any given situation, one of skill in the art may envision an appropriate "synergistically effective amount" in light of the terms and context of the disclosure contained herein.

For example, a "synergistically effective amount" of black maca root disclosed herein can be, e.g., 01mg/kg, 2mg/kg, 3mg/kg, 4mg/kg, 5mg/kg, 6mg/kg, 7mg/kg, 8mg/kg, 9mg/kg, 10mg/kg, 15mg/kg, 20mg/kg, 25mg/kg, 30mg/kg, 35mg/kg, 40mg/kg, 45mg/kg, 50mg/kg, 55mg/kg, 60mg/kg, 65mg/kg, 70mg/kg, 75mg/kg, 80mg/kg, 85mg/kg, 90mg/kg, 95mg/kg, 100mg/kg, 105mg/kg, 110mg/kg, 115mg/kg, 120mg/kg, 125mg/kg, 130mg/kg, 135mg/kg, 140mg/kg, 145mg/kg, 150mg/kg, 155mg/kg, 160mg/kg, 165mg/kg, 170mg/kg, 175mg/kg, 180mg/kg, 185mg/kg, 190mg/kg, 195mg/kg, 200mg/kg or more, or any amount therebetween. Thus, in some embodiments, the synergistically effective amount of maca root in the compositions disclosed herein may be from about 1mg to about 5g (preferably per day). For example, the amount of maca root may be (preferably daily) from about 1mg to about 5 g. For example, the amount of maca root can be 1mg, 10mg, 100mg, 500mg, 1g, 1.5g, 2g, 2.5g, 3g, 3.5g, 4g, 4.5g, or 5g or more, or any range or amount between any two of the foregoing values.

For example, a "synergistically effective amount" of red maca root disclosed herein can be, e.g., 1mg/kg, 2mg/kg, 3mg/kg, 4mg/kg, 5mg/kg, 6mg/kg, 7mg/kg, 8mg/kg, 9mg/kg, 10mg/kg, 15mg/kg, 20mg/kg, 25mg/kg, 30mg/kg, 35mg/kg, 40mg/kg, 45mg/kg, 50mg/kg, 55mg/kg, 60mg/kg, 65mg/kg, 70mg/kg, 75mg/kg, 80mg/kg, 85mg/kg, 90mg/kg, 95mg/kg, 100mg/kg, 105mg/kg, 110mg/kg, 115mg/kg, 120mg/kg, 125mg/kg, 130mg/kg, 135mg/kg, 140mg/kg, 145mg/kg, 150mg/kg, 155mg/kg, 160mg/kg, 165mg/kg, 170mg/kg, 175mg/kg, 180mg/kg, 185mg/kg, 190mg/kg, 195mg/kg, 200mg/kg or more, or any amount therebetween. Thus, in some embodiments, the synergistically effective amount of red maca root in the compositions disclosed herein may be (preferably daily) from about 1mg to about 3 g. For example, the amount of red maca root may be (preferably daily) from about 1mg to about 5 g. For example, the amount of red maca root may be 1mg, 10mg, 100mg, 500mg, 1g, 1.5g, 2g, 2.5g, 3g, 3.5g, 4g, 4.5g, or 5g or more, or any range or amount between any two of the foregoing values.

For example, a "synergistically effective amount" of a root of Xanthomonas disclosed herein can be, e.g., 1mg/kg, 2mg/kg, 3mg/kg, 4mg/kg, 5mg/kg, 6mg/kg, 7mg/kg, 8mg/kg, 9mg/kg, 10mg/kg, 15mg/kg, 20mg/kg, 25mg/kg, 30mg/kg, 35mg/kg, 40mg/kg, 45mg/kg, 50mg/kg, 55mg/kg, 60mg/kg, 65mg/kg, 70mg/kg, 75mg/kg, 80mg/kg, 85mg/kg, 90mg/kg, 95mg/kg, 100mg/kg, 105mg/kg, 110mg/kg, 115mg/kg, 120mg/kg, 125mg/kg, 130mg/kg, 135mg/kg, 140mg/kg, 145mg/kg, 150mg/kg, 155mg/kg, 160mg/kg, 165mg/kg, 170mg/kg, 175mg/kg, 180mg/kg, 185mg/kg, 190mg/kg, 195mg/kg, 200mg/kg or more, or any amount therebetween. Thus, in some embodiments, a synergistically effective amount of the root of maca in the compositions disclosed herein may be (preferably daily) from about 1mg to about 5 g. For example, the amount of root of maca may be (preferably daily) from about 1mg to about 5 g. For example, the amount of the root of maca may be 1mg, 10mg, 100mg, 500mg, 1g, 1.5g, 2g, 2.5g, 3g, 3.5g, 4g, 4.5g, or 5g or more, or any range or amount between any two of the foregoing values.

For example, a "synergistically effective amount" of a green maca root disclosed herein can be, e.g., 1mg/kg, 2mg/kg, 3mg/kg, 4mg/kg, 5mg/kg, 6mg/kg, 7mg/kg, 8mg/kg, 9mg/kg, 10mg/kg, 15mg/kg, 20mg/kg, 25mg/kg, 30mg/kg, 35mg/kg, 40mg/kg, 45mg/kg, 50mg/kg, 55mg/kg, 60mg/kg, 65mg/kg, 70mg/kg, 75mg/kg, 80mg/kg, 85mg/kg, 90mg/kg, 95mg/kg, 100mg/kg, 105mg/kg, 110mg/kg, 115mg/kg, 120mg/kg, 125mg/kg, 130mg/kg, 135mg/kg, 140mg/kg, 145mg/kg, 150mg/kg, 155mg/kg, 160mg/kg, 165mg/kg, 170mg/kg, 175mg/kg, 180mg/kg, 185mg/kg, 190mg/kg, 195mg/kg, 200mg/kg or more, or any amount therebetween. Thus, in some embodiments, the synergistically effective amount of green maca root in the compositions disclosed herein may be (preferably daily) from about 1mg to about 5 g. For example, the amount of green maca root may be (preferably daily) from about 1mg to about 5 g. For example, the amount of green maca root may be 1mg, 10mg, 100mg, 500mg, 1g, 1.5g, 2g, 2.5g, 3g, 3.5g, 4g, 4.5g, or 5g or more, or any range or amount between any two of the foregoing values.

For example, a "synergistically effective amount" of a root of Blackia agalmainensis disclosed herein can be, e.g., 1mg/kg, 2mg/kg, 3mg/kg, 4mg/kg, 5mg/kg, 6mg/kg, 7mg/kg, 8mg/kg, 9mg/kg, 10mg/kg, 15mg/kg, 20mg/kg, 25mg/kg, 30mg/kg, 35mg/kg, 40mg/kg, 45mg/kg, 50mg/kg, 55mg/kg, 60mg/kg, 65mg/kg, 70mg/kg, 75mg/kg, 80mg/kg, 85mg/kg, 90mg/kg, 95mg/kg, 100mg/kg, 105mg/kg, 110mg/kg, 115mg/kg, 120mg/kg, 125mg/kg, 130mg/kg, 135mg/kg, 140mg/kg, 145mg/kg, 150mg/kg, 155mg/kg, 160mg/kg, 165mg/kg, 170mg/kg, 175mg/kg, 180mg/kg, 185mg/kg, 190mg/kg, 195mg/kg, 200mg/kg or more, or any amount therebetween. Thus, in some embodiments, a synergistically effective amount of blue maca root in a composition disclosed herein may be (preferably daily) from about 1mg to about 5 g. For example, the amount of blue maca root may be (preferably daily) from about 1mg to about 5 g. For example, the amount of blue maca root may be 1mg, 10mg, 100mg, 500mg, 1g, 1.5g, 2g, 2.5g, 3g, 3.5g, 4g, 4.5g, or 5g or more, or any range or amount between any two of the foregoing values.

For example, a "synergistically effective amount" of purple maca root disclosed herein can be, e.g., 1mg/kg, 2mg/kg, 3mg/kg, 4mg/kg, 5mg/kg, 6mg/kg, 7mg/kg, 8mg/kg, 9mg/kg, 10mg/kg, 15mg/kg, 20mg/kg, 25mg/kg, 30mg/kg, 35mg/kg, 40mg/kg, 45mg/kg, 50mg/kg, 55mg/kg, 60mg/kg, 65mg/kg, 70mg/kg, 75mg/kg, 80mg/kg, 85mg/kg, 90mg/kg, 95mg/kg, 100mg/kg, 105mg/kg, 110mg/kg, 115mg/kg, 120mg/kg, 125mg/kg, 130mg/kg, 135mg/kg, 140mg/kg, 145mg/kg, 150mg/kg, 155mg/kg, 160mg/kg, 165mg/kg, 170mg/kg, 175mg/kg, 180mg/kg, 185mg/kg, 190mg/kg, 195mg/kg, 200mg/kg or more, or any amount therebetween. Thus, in some embodiments, the synergistically effective amount of the purple maca root in the compositions disclosed herein may be from about 1mg to about 5g (preferably per day). For example, the amount of purple maca root may be (preferably daily) from about 1mg to about 5 g. For example, the amount of purple maca root may be 1mg, 10mg, 100mg, 500mg, 1g, 1.5g, 2g, 2.5g, 3g, 3.5g, 4g, 4.5g, or 5g or more, or any range or amount between any two of the foregoing values.

In some embodiments, the composition comprises a synergistically effective amount of black maca and a synergistically effective amount of yellow maca. In some embodiments, the composition comprises a synergistically effective amount of black maca and a synergistically effective amount of red maca. In some embodiments, the composition comprises a synergistically effective amount of black maca and a synergistically effective amount of yellow maca. In some embodiments, the composition comprises a synergistically effective amount of red maca and a synergistically effective amount of yellow maca.

In some embodiments, the composition comprises a synergistically effective amount of red maca, a synergistically effective amount of yellow maca, and a synergistically effective amount of black maca. Certain embodiments may comprise a synergistically effective amount of yellow, red, black, green, blue or purple maca and combinations thereof.

In some embodiments, the maca root phenotype is present in a synergistically effective amount in the following ratio: 1: 1. 1: 2. 1: 3. 1: 4. 1: 5. 1: 6. 1: 7. 1: 8: 1: 9. 1: 10. 1: 15. 1: 20. 1: 30. 1: 40. 1: 50. 1: 1: 1. 1: 1: 2. 1: 1: 3. 1: 1: 4. 1: 1: 5. 1: 1: 6. 1: 1: 7. 1: 1: 8. 1: 1: 9. 1: 1: 10. 1: 2: 1. 1: 2: 2. 1: 2: 3. 1: 2: 4. 1: 2: 5. 1: 2: 6. 1: 2: 7. 1: 2: 8. 1: 2: 9. 1: 2: 10. 1: 3: 1. 1: 3: 2. 1: 3: 3. 1: 3: 4. 1: 3: 5. 1: 3: 6. 1: 3: 7. 1: 3: 8. 1: 3: 9. 1: 3: 10. 1: 4: 1. 1: 4: 2. 1: 4: 3. 1: 4: 4. 1: 4: 5. 1: 4: 6. 1: 4: 7. 1: 4: 8. 1: 4: 9. 1: 4: 10. 1: 5: 1. 1: 5: 2. 1: 5: 3. 1: 5: 4. 1: 5: 5. 1: 5: 6. 1: 5: 7. 1: 5: 8. 1: 5: 9. 1: 5: 10. 1: 6: 1. 1: 6: 2. 1: 6: 3. 1: 6: 4. 1: 6: 5. 1: 6: 6. 1: 6: 7. 1: 6: 8. 1: 6: 9. 1: 6: 10. 1: 7: 1. 1: 7: 2. 1: 7: 3. 1: 7: 4. 1: 7: 5. 1: 7: 6. 1: 7: 7. 1: 7: 8. 1: 7: 9. 1: 7: 10. 1: 8: 1. 1: 8: 2. 1: 8: 3. 1: 8: 4. 1: 8: 5. 1: 8: 6. 1: 8: 7. 1: 8: 8. 1: 8: 9. 1: 8: 10. 1: 9: 1. 1: 9: 2. 1: 9: 3. 1: 9: 4. 1: 9: 5. 1: 9: 6. 1: 9: 7. 1: 9: 8. 1: 9: 9. 1: 9: 10. 1: 10: 1. 1: 10: 2. 1: 10: 3. 1: 10: 4. 1: 10: 5. 1: 10: 6. 1: 10: 7. 1: 10: 8. 1: 109: 9. 1: 10: 10, or any ratio therebetween.

In some embodiments, the synergistic maca composition comprises 1: 1 black-yellow maca root. In some embodiments, the synergistic maca composition comprises 1: 1 yellow-red maca root. In some embodiments, the synergistic maca composition comprises 1: 1 black-red maca root. In some embodiments, the synergistic maca composition comprises 2: 1 black-red maca root. In some embodiments, the synergistic maca composition comprises 4:1 black-red maca root. In some embodiments, the synergistic maca composition comprises 1: 4 black-red maca root.

Examples of embodiments of compositions of synergistic combinations of maca compared to compositions of maca of the prior art are shown in table 1 below:

TABLE 1

The composition of the synergistic combination of black and yellow maca consists of certain components including, but not limited to, those shown in table 1. The embodiments of the invention disclosed herein comprise specific isolated maca phenotypes which are then combined in the specific ratios described herein to achieve unique and unexpectedly superior results compared to those existing in the prior art. Without being bound by theory, the inventors have also determined that certain ranges of components of maca compositions are produced by a combination of certain isolated phenotypes, which are different from those present in the prior art. These differences are evidenced by the uniquely developed compositions and their uniquely configured chemical compositions as described herein. In some embodiments, the processing of maca compositions may be further used to obtain compositions including those shown in table 1. In some embodiments, further processing (which may include heating, or further extraction in water or alcohol) may be employed to alter (i.e., raise or lower) particular components of the maca composition (e.g., those components listed in table 1). In certain embodiments, the maca composition comprises from about 15 to about 40 grams of total sugar per 100 grams of maca composition. In certain embodiments, the maca composition may comprise about 15, about 20, about 25, about 30, about 35, about 40, about 25 to about 35, or about 30 to about 35 grams of total sugar per 100 grams of maca composition and ranges therebetween. Some embodiments of the maca composition may include greater than about 15 grams of total sugar per 100 grams of maca composition.

In certain embodiments, the maca composition comprises from about 10 to about 15 grams of protein per 100 grams of maca composition. In certain embodiments, the maca composition may comprise a range of about 10, about 12, about 15, about 10 to about 12, about 12 to about 15, or about 11 to about 15 grams of protein per 100 grams of maca composition and ranges therebetween. Some embodiments of the maca composition may include greater than about 10 grams of protein per 100 grams of maca composition.

In certain embodiments, the maca composition comprises from about 9000 to about 12000mg of total amino acids per 100 grams of maca composition. In certain embodiments, the maca composition comprises about 9000, about 9750, about 9800, about 10000, about 11000, about 11500, or about 12000mg total amino acids per 100 grams of maca composition, and ranges therebetween. In certain embodiments, the maca composition has a total number of amino acids per 100 grams of maca composition of between about 9800 and about 11750, between about 9500 and about 11500, between about 9000 and about 10000, or between about 10000 and about 11600mg, and ranges therebetween. Certain embodiments of the maca composition may comprise greater than about 9000mg of total amino acids per 100 grams of maca composition. Certain embodiments may comprise from about 3000mg to about 5000mg of proline per 100 grams of maca composition. Certain embodiments may comprise from about 2500mg to about 6000mg, from about 3500mg to about 4500mg of proline per 100 grams of maca composition, and ranges therebetween.

In certain embodiments, the pH of the maca composition is less than about 5.4. In certain embodiments, the pH of the maca composition may be from about 5.1 to about 5.3, from about 5.15 to about 5.26, from about 5.1 to about 5.4, and ranges therebetween.

In certain embodiments, the maca composition may comprise from about 0.3 to about 0.8 grams of free fatty acid as oleic acid per 100 grams of maca composition. In certain embodiments, the maca composition may comprise from about 0.3 to about 0.4, from about 0.34 to about 0.36, from about 0.35 to about 0.8, or from about 0.5 to about 0.8 grams of free fatty acid as oleic acid per 100 grams of maca composition, and ranges therebetween. In certain embodiments, the maca composition may comprise about 0.35, about 0.3, about 0.4, about 0.5, or about 0.8 grams of free fatty acids as oleic acid per 100 grams of maca composition and ranges therebetween. Some embodiments of the maca composition may include less than about 0.8 grams of free fatty acids as oleic acid per 100 grams of maca composition.

Certain embodiments of the maca composition may comprise a predetermined amount of total polyphenols. In some embodiments, the total polyphenols may comprise gallic acid equivalents. In certain embodiments, the maca composition may comprise from about 250 to about 450, from about 250 to about 300, from about 250 to about 350, from about 350 to about 400, from about 250 to about 375, or from about 350 to about 415mg total polyphenols per 100 grams of maca composition and ranges therebetween. In certain embodiments, the maca composition may comprise about 250, about 350, about 365, about 375, about 400, or about 415mg of total polyphenols per 100 grams of maca composition, and ranges therebetween. In some embodiments, the maca composition may comprise greater than about 250mg of total polyphenols per 100 grams of maca composition.

In certain embodiments, the maca composition may comprise from about 0.2 to about 0.35 μmol of glucostaphin per gram of maca composition. In certain embodiments, the maca composition may comprise from about 0.2 to about 0.3, from about 0.25 to about 0.35, or from about 0.30 to about 0.35 μmol of giycostin per gram of maca composition, and ranges therebetween. In certain embodiments, the maca composition may comprise about 0.2, about 0.3, or about 0.35 μmol of capsaicinoid per gram of maca composition. In some embodiments, the maca composition may comprise greater than about 0.2 μmol of capsamine glucosylcharaide per gram of maca composition.

In certain embodiments, the maca composition may comprise from about 0.2 to about 0.5 μmol of 4-hydroxyglucose brassin per gram of maca composition. In certain embodiments, the maca composition may comprise from about 0.2 to about 0.3, from about 0.25 to about 0.5, from about 0.4 to about 0.49, or from about 0.30 to about 0.4 μmol of 4-hydroxyglucose brassin per gram of maca composition, and ranges therebetween. In certain embodiments, the maca composition may comprise about 0.2, about 0.25, about 0.35, or about 0.49 μmol of 4-hydroxyglucose brassinol per gram of maca composition, and ranges therebetween. In some embodiments, the maca composition may comprise greater than about 0.2 μmol of 4-hydroxyglucose brassin per gram of maca composition.

In certain embodiments, the maca composition may comprise from about 5 to about 13 μmol of tropaeolum glucosinolates per gram of maca composition. In certain embodiments, the maca composition may comprise from about 7 to about 13, from about 8 to about 13, from about 5 to about 8, from about 10 to about 13, or from about 12 to about 13 μmol of tropaeolum glucosinolates per gram of maca composition, and ranges therebetween. In certain embodiments, the maca composition may comprise about 5, about 8, about 10, about 12, or about 13 μmol of tropaeolum glucosinolates per gram of maca composition, and ranges there between. In some embodiments, the maca composition may comprise greater than about 5 μmol of tropaeolum glucosinolates per gram of maca composition.

In certain embodiments, the maca composition may comprise a predetermined amount of glucosinolates. In some embodiments, the glucosinolate may be selected from the group consisting of glucomuslin, 4-hydroxyglucose brassin, and tropaeolum glucosinolate. In certain embodiments, the maca composition may comprise from about 200 to about 700mg of total glucosinolates per 100 grams of maca composition. In certain embodiments, the maca composition may comprise from about 200 to about 350, from about 330 to about 570, from about 500 to about 575, from about 500 to about 700, from about 600 to about 700, or from about 300 to about 350mg of total glucosinolates per 100g of maca composition, and ranges therebetween. In some embodiments, the maca composition may comprise about 200, about 340, about 350, about 500, about 570, about 575, about 600, about 650, or about 700mg of total glucosinolates per 100g of maca composition, and ranges therebetween. In certain embodiments, the maca composition may comprise greater than about 200mg of total glucosinolates per 100 grams of maca composition.

In certain embodiments, the maca composition may comprise from about 5 to about 14 μmol total glucosinolates per gram of maca composition. In certain embodiments, the maca composition may comprise from about 5 to about 8, from about 8 to about 14, from about 8 to about 8.25, from about 13 to about 14, or from about 8.5 to about 13.5 μmol total glucosinolates per gram of maca composition and ranges therebetween. In some embodiments, the maca composition may comprise about 5, about 8, about 8.5, about 8.25, about 13, or about 14 μmol total glucosinolates per gram maca composition, and ranges therebetween. In some embodiments, the maca composition may comprise greater than about 5 μmol total glucosinolates per gram of maca composition.

The following examples are provided for illustrative purposes and are not intended to limit the scope of the present application or claims in any way.

Examples

Aqueous and ethanol extracts of processed maca root and maca root mixtures were obtained using standard extraction methods. Aqueous extracts as shown in table 2 were used in the following examples.

Table 2: maca root preparation

Example 1: effect of maca composition under inflammatory conditions

Human Peripheral Blood Mononuclear Cell (PBMC) cultures were treated with highly inflammatory bacterial Lipopolysaccharide (LPS) from e. Cultures were incubated for 24 hours, then cells and culture supernatants were harvested and used to monitor the reactions in each culture. Using Luminex magnetic bead array andmultiple systems test selected cytokines, supernatants from each culture were used to test a panel of pro-inflammatory and anti-inflammatory cytokines and anti-viral chemokines, as shown in FIGS. 1-11.

Cell activation tests were performed such that all treatments (including each dose of test product and each positive and negative control) were tested in triplicate. Cytokine production assays were tested in duplicate. Cells from a healthy donor were tested.

The mean and standard deviation of each data set were calculated using Microsoft Excel and statistical comparison. Statistical analysis of in vitro data was performed by comparing the measurements of the specific test conditions (in duplicate for the Luminex cytokine test) with the relevant controls. Tail part: the two-tailed t-test is applied because the test material can induce or inhibit a particular assay result. Type (2): independent or "unpaired" tests were applied because each cell culture was unique, located in a different area of the microplate and slightly different in environmental exposure, and though uniform, not identical by assay treatment (e.g. pipetting). Statistical significance is indicated if p <0.05 and high levels of significance are indicated if p < 0.01.

The effect of maca roots and mixtures on PBMC cytokine production was tested according to the protocol described above. The following table lists 10 cytokines/chemokines and a brief description of their primary mode of action. This description is followed by the results of the test on PBMC culture supernatants and after administration of a 0.5mg/mL dose of the test product.

FIG. 1 shows the change in IL-1 β levels in PBMC (peripheral blood mononuclear cells) culture supernatants treated with serial dilutions of the test product in the presence of bacterial Lipopolysaccharide (LPS) for 24 hours. Data are shown as group mean plus or minus standard deviation for each replicate data set when compared to mean cytokine production for LPS-treated cultures in the absence of test product.

FIG. 2 shows the change in IL-4 levels in supernatants of PBMC cultures treated with serial dilutions of the test product for 24 hours in the presence of bacterial Lipopolysaccharide (LPS). Data are shown as group mean plus or minus standard deviation for each replicate data set when compared to mean cytokine production for LPS-treated cultures in the absence of test product.

FIG. 3 shows the change in IL-6 levels in supernatants of PBMC cultures treated with serial dilutions of the test product for 24 hours in the presence of bacterial Lipopolysaccharide (LPS). Data are shown as group mean plus or minus standard deviation for each replicate data set when compared to mean cytokine production for LPS-treated cultures in the absence of test product.

FIG. 4 shows the change in IL-8 levels in supernatants of PBMC cultures treated with serial dilutions of the test product for 24 hours in the presence of bacterial Lipopolysaccharide (LPS). Data are shown as group mean plus or minus standard deviation for each replicate data set when compared to mean cytokine production for LPS-treated cultures in the absence of test product.

FIG. 5 shows the change in IL-10 levels in supernatants of PBMC cultures treated with serial dilutions of the test product for 24 hours in the presence of bacterial Lipopolysaccharide (LPS). Data are shown as group mean plus or minus standard deviation for each replicate data set when compared to mean cytokine production for LPS-treated cultures in the absence of test product.

FIG. 6 shows the change in IFN- γ levels in supernatants of PBMC cultures treated with serial dilutions of the test product for 24 hours in the presence of bacterial Lipopolysaccharide (LPS). Data are shown as group mean plus or minus standard deviation for each replicate data set when compared to mean cytokine production for LPS-treated cultures in the absence of test product.

FIG. 7 shows the change in TNF-. alpha.levels in supernatants of PBMC cultures treated with serial dilutions of the test product for 24 hours in the presence of bacterial Lipopolysaccharide (LPS). Data are shown as group mean plus or minus standard deviation for each replicate data set when compared to mean cytokine production for LPS-treated cultures in the absence of test product.

Figure 8 shows the variation of RANTES levels in supernatants of PBMC cultures treated with serial dilutions of the test product for 24 hours in the presence of bacterial Lipopolysaccharide (LPS). Data are shown as group mean plus or minus standard deviation for each replicate data set when compared to mean cytokine production for LPS-treated cultures in the absence of test product.

FIG. 9 shows the change in IP-10 levels in supernatants of PBMC cultures treated with serial dilutions of the test product for 24 hours in the presence of bacterial Lipopolysaccharide (LPS). Data are shown as group mean plus or minus standard deviation for each replicate data set when compared to mean cytokine production for LPS-treated cultures in the absence of test product.

FIG. 10 shows the change in IL-2 levels in supernatants of PBMC cultures treated with serial dilutions of the test product for 24 hours in the presence of bacterial Lipopolysaccharide (LPS). Data are shown as group mean plus or minus standard deviation for each replicate data set when compared to mean cytokine production for LPS-treated cultures in the absence of test product.

FIG. 11 shows changes in mitochondrial function in PBMC cultures treated with serial dilutions of test product in the presence of bacterial Lipopolysaccharide (LPS) for 24 hours. These PBMC cultures were exposed to 6 4-fold serial dilutions of each product, starting at 2 mg/mL. Test conditions were performed in triplicate, and cultures were incubated at 37 ℃ and 5% CO₂And keeping for 24 hours. After 24 hours of incubation, the cultures were processed in a colorimetric MTT assay. MTT assay utilizes a dye, thereforThe dyes change color according to mitochondrial function, which is directly related to cellular metabolic activity and viability. Healthy cells metabolize the MTT dye and the culture becomes purple. When a decrease in color is measured, this is associated with a decrease in cell viability, either due to direct cell killing or inhibition of mitochondrial function leading to cell death. In this case, a measured increase in color was measured, indicating an increase in mitochondrial function (energy production) because unstimulated PBMCs did not undergo cell division within 24 hours, and the increased colorimetric readings observed in several maca-treated cell cultures were likely to be related to a direct effect on cellular energy production. Data are shown as group mean plus or minus standard deviation for each replicate data set when compared to mean cytokine production for LPS-treated cultures in the absence of test product.

These results show that the composition comprises 4:1, black maca root: red maca root and 1: 1, black maca root: the composition of the root of the yellow maca has a remarkable anti-inflammatory effect. For example, but not limiting of, IL-6(0.02g), IL-8(0.5 and 0.02g/L) and IL-1 β were all more reduced than black or red maca root alone. This result is either unexpected or predicted.

Example 2: effect of maca compositions on inflammation

A double-blind, randomized, parallel group dose finding trial study compared 40 outpatients (mean age 30 years; half female, half male) with the appropriate daily dose of maca composition as a daily regimen with placebo control. These patients have a diagnosed chronic inflammatory and/or autoimmune disease, disorder, or condition. The composition may, for example, comprise a predetermined amount of maca per kilogram of body weight of the subject. The subject is required to have exhibited symptoms of a chronic inflammatory and/or autoimmune disease, disorder, or condition for at least six months prior to the start of the trial, and may not have begun any new drug treatment within six months of the start of the trial.

The subjects were divided into 8 groups, group A, group B, group C, group D and group E. Group a is a control group, group B received only the yellow maca, group C received 1: 1 black to red maca, group D receives 4:1 black to red maca, group E received 1: 1 black to yellow maca. Blood samples were taken from each subject at weeks 0, 1, 4, 8, 12 and 16. Cytokine levels were measured in each sample. At each blood draw, subjects also completed a brief questionnaire regarding their symptoms.

Each group of subjects reported mild to moderate remission, with group B subjects reporting similarity to control group a. Group C, group D subjects reported the greatest improvement in symptoms relative to groups a and B, with group D subjects reporting the greatest improvement. Similarly, groups C and D also had the greatest reduction in cytokine levels, particularly at the level of IL-6.

Example 3: effect of maca compositions on sexual desire and function

A double-blind, randomized, parallel group dose discovery trial study was conducted to compare the appropriate daily dose of maca composition as a daily regimen (relative to placebo controls) in 40 outpatients (mean age 36 years; 17 women) who were diagnosed with sexual dysfunction. The composition may, for example, comprise a predetermined amount of maca per kilogram of body weight of the subject. The subject must meet one of the following criteria for at least 4 weeks: (1) inability to reach orgasm (anorgasmia) during sexual activity; (2) according to self-report, clinically significant orgasmic delay during masturbation or intercourse represents significant delay and interfering function compared to the time a subject usually reaches orgasm; (3) according to self-reporting, there is no adequate erectile or lubrication processes response to achieve or maintain sexual arousal prior to completion of sexual activity, i.e. interference with sexual function compared to prior antidepressant drug treatment; (4) according to self-reporting decreased libido.

Exclusion criteria included: primary or previous diagnosis of sexual abnormalities; sexual dysfunction secondary to general underlying medical conditions; no other primary psychiatric disorder is present; abuse or dependence on alcohol or drugs over the past 6 months; recent ongoing or anticipated change, disruption or confusion of primary relationships not related to sexual dysfunction, HAM-D-17 or HAM-A score (either) > 10; other drugs or other treatments or drugs for sexual dysfunction are currently used to treat sexual dysfunction; hormone replacement therapy, unless the patient has been on stable doses of hormone therapy for at least 3 months prior to antidepressant treatment, there is no sexual dysfunction in the same hormone treatment regimen and there is no change in hormone replacement therapy during the study; pregnancy, lactation or planned pregnancy during the study; any clinically significant screening physical abnormalities; any medical or psychological condition or social environment that impairs the ability of a subject to participate in a study trustworthily, or that may increase the risk to the subject or others as a result of participating in a study; testosterone was implanted 6 months before screening; receiving psychosexual or other treatment for sexual dysfunction and reluctant to stop treatment at screening; and/or objects that are not amenable to sexual activity.

The subjects were divided into 8 groups, group A, group B, group C, group D and group E. Group a was a control group, group B received yellow maca only, group C received 1: 1 black to red maca, group D receives 4:1 black to red maca, group E received 1: 1 black to yellow maca. Arizona Sexual expert Scale (ASEX) and Massachusetts General Hospital Sexual Function Questionaire (MGH-SFQ) were used to measure Sexual dysfunction. Subjects in group B reported similar results to control group a. C. Subjects in group D reported improved sexual function and libido relative to groups a and B, with the greatest improvement reported by subjects in group D.

Example 4 reduction of fatigue and improvement of metabolic Activity

Rats were randomly divided into 4 groups of similar body weight as follows: 1) control group (vehicle); 2) maca powder (40mg/kg body weight), 3) exercise; 4) exercise + maca powder (40mg/kg body weight), wherein the group administered a maca composition as described herein was given a composition comprising a mixture of maca and maca in a ratio of 4:1 maca composition of black and red macas. The control group was treated with a similar volume of vehicle without any maca. Those groups receiving doses of maca powder received maca powder in the stomach in a volume of 0.2g/10mL once a day for 21 consecutive days. The control group was treated with a similar volume of vehicle without any maca powder.

Rats were swim for 10 minutes without weight, twice a week, to acclimatize them for swimming. On day 14 of the experiment, a weight swimming test was used to evaluate the effect of maca powder on the endurance of the mice and to determine the effect on certain indicators related to physical exertion. After 30 minutes of oral administration of maca powder or maca powder-free vehicle, rats were individually dropped into acrylic plastic pools containing fresh water maintained at 27 + -1 deg.C and approximately 35 cm deep. Rats were loaded with lead blocks weighing approximately 5% of the body weight and attached to the tail. The swimming time to exhaustion is used as an index of the degree of fatigue. Rats were considered to be exhausted when they could not remove their nose from the water within 10 seconds.

After the weight-bearing swimming test, control and test rats were orally administered with the maca-free vehicle and the maca root composition-containing vehicle for 7 days, respectively. Each rat was sacrificed immediately 30 minutes after the last dose on day 21, after 90 minutes of swimming without load. The swimming time causing fatigue is selected according to methods known in the art. Blood, liver, muscle and brain samples were collected. Levels of serum glucose, Lactate (LD), Lactate Dehydrogenase (LDH), Blood Urea Nitrogen (BUN), and liver glycogen content were measured using commercially available kits according to the manufacturer's instructions.

Immediately after blood collection, the brain, liver and left gastrocnemius muscles were quickly excised and maintained at-80 ℃ until analysis. Each tissue was homogenized in ice-cold physiological saline. These tissue homogenates were centrifuged at 3000rpm for 10 minutes at 4 ℃ and the supernatants were evaluated for antioxidant status.

The activity of superoxide dismutase (SOD) and glutathione peroxidase (GSH-PX), the content of the lipid peroxidation product Malondialdehyde (MDA), was determined using commercially available kits according to the manufacturer's protocol. SIRT1, mitochondrial Transcription Factor A (TFAM), NF-. kappa.B and Nrf2 were analyzed in muscle samples by immunoblotting using methods known in the art.

TABLE 3 Experimental protocol

The experimental protocol used is given in table 3 above. The following table summarizes the experimental results obtained.

Table 4-by administration ratio 4:1 black color: experimental results obtained with red maca compositions.

The data in table 4 are given as mean ± SEM. Sample size was calculated based on 85% efficacy and p value of 0.05. In view of this assumption, a sample size of 7 per process is used. Data were analyzed using the GLM program of SAS (SAS Institute: SAS User's Guide: staticiscs), as is known to those skilled in the art. Unpaired t-test comparative treatment using ANOVA and students; p <0.05 was considered statistically significant.

Figure 12 shows the increase in forced swimming time achieved by rats subjected to the protocol of example 4. The increased forced swimming time was measured after application of a maca composition comprising black maca and red maca in a ratio of 4: a ratio of 1 is present.

FIG. 13 shows the decrease in NF- κ B measured in rats in the protocol of example 4. The reduction in NF- κ B was measured after application of a maca composition comprising black maca and red maca, wherein the black maca and red maca are mixed at a ratio of 4: a ratio of 1 is present.

FIG. 14 shows the increase in SIRT-1 measured in rats in the protocol of example 4. The increase in SIRT-1 was measured after applying a maca composition comprising black maca and red maca, wherein the black maca and red maca were mixed at a ratio of 4: a ratio of 1 is present.

FIG. 15 shows the increase in mitochondrial Transcription Factor A (TFAM) measured in rats in the protocol of example 4. The increase in TFAM was measured after administration of a maca composition comprising black maca and red maca, wherein the black maca and red maca are present in a ratio of 4: a ratio of 1 is present.

FIG. 16 shows the increase in nuclear respiratory factor 1(Nrf-1) measured in rats in the protocol of example 4. The increase in Nrf-1 was measured after application of a maca composition comprising black maca and red maca, wherein the black maca and red maca are mixed at a ratio of 4: a ratio of 1 is present.

FIG. 17 shows the increase of the nuclear factor erythroid 2(Nrf-2) measured in rats in the protocol of example 4. The increase in Nrf-2 was measured after application of a maca composition comprising black maca and red maca, wherein the black maca and red maca were mixed at a ratio of 4: a ratio of 1 is present.

FIG. 18 shows the increase of peroxisome proliferator activated receptor- γ coactivator (PGC-1) measured in rats in the protocol of example 4. The increase in PGC-1 activity was measured after administration of a maca composition comprising black maca and red maca, wherein the black maca and red maca are mixed at a ratio of 4: a ratio of 1 is present.

The methods, compositions, and apparatus described herein are presently representative of preferred embodiments and are exemplary and are not intended as limitations on the scope of the invention. Those skilled in the art will recognize modifications and other uses thereof that are within the spirit of the invention and are limited by the scope of the disclosure. Accordingly, it will be apparent to those skilled in the art that various substitutions and modifications may be made to the invention disclosed herein without departing from the scope and spirit of the invention.

The phrase "consisting essentially of, as used in the following claims and throughout this disclosure, is meant to include any elements listed after the phrase, and is limited to other elements that do not interfere with or contribute to the specified activity or effect of the elements listed in this disclosure. Thus, the phrase "consisting essentially of means that the listed elements are required or mandatory, but other elements are optional and may or may not be present, depending on whether they affect the activity or action of the listed elements.