阅读说明：本技术 包含菊粉和蛋白质的组合物 (Composition comprising inulin and protein ) 是由 H.雅各布斯 J.萨尔斯 S.瓦尔朗 C.西格诺雷特 于 2020-05-22 设计创作，主要内容包括：本发明涉及包含菊粉和蛋白质的的组合物,其用于减少肌肉质量损失。本发明还涉及包含菊粉和蛋白质的组合物,其中所述菊粉与所述蛋白质的比率以重量计介于5/95至75/25之间。因此,本发明还涉及包含菊粉和蛋白质的组合物用于制备食物或药物的用途。(The present invention relates to a composition comprising inulin and protein for use in reducing muscle mass loss. The invention also relates to a composition comprising inulin and protein, wherein the ratio of inulin to protein is between 5/95 and 75/25 by weight. The invention therefore also relates to the use of a composition comprising inulin and protein for the preparation of a food or a medicament.)

1. A composition comprising inulin and protein for use in preventing and/or reducing loss of muscle mass.

2. A composition comprising inulin and protein for increasing biological value, net protein utilization and/or nitrogen balance.

3. Composition according to any one of claims 1 to 2, in which the ratio of inulin to protein is between 5/95 and 75/25 by weight.

4. A composition according to any one of claims 1 to 3, wherein the inulin is obtained from a plant selected from the group comprising: elecampane, dandelion, dahlia, wild yam, artichoke, jerusalem artichoke, chicory, burdock, onion, garlic, agave, yacon, banana, leek, asparagus, clematis terniflora or a mixture thereof.

5. The composition according to any one of claims 1 to 4, wherein the protein is selected from animal proteins, plant proteins, alone or in mixtures thereof.

6. Composition according to claim 5, wherein the protein is a vegetable protein, more preferably a legume protein, even more preferably a pea protein.

7. The composition according to claim 5, wherein the protein is an animal protein, more preferably a whey protein.

8. The composition according to any one of claims 1 or 3-7, wherein the loss of muscle mass is caused by insufficient physical activity, chronic diseases such as diabetes, obesity, sarcopenia.

9. The composition according to claim 8, wherein the loss of muscle mass is caused by sarcopenia.

10. A composition according to any one of claims 1 to 9, wherein inulin and protein have a synergistic effect.

11. A composition comprising inulin and protein, wherein the ratio of inulin to protein is between 5/95 and 75/25 by weight, and comprises at least 65%, preferably at least 75%, more preferably at least 85%, even more preferably at least 95%, most preferably at least 98% by weight of dry matter of protein and inulin.

12. Food or beverage or food supplement comprising between 0.1 and 40g of the composition according to any one of claims 1 to 11 per serving of said food or beverage or food supplement, and/or comprising between 5% and 75%, preferably between 10% and 65% by weight of dry matter of the composition according to any one of claims 1 to 11.

13. Use of a composition according to any one of claims 1 to 11 as a food additive or feed additive in the manufacture of a food or beverage product or food supplement comprising between 0.1 and 40g of said composition per serving of said food or beverage product or food supplement, and/or comprising between 5% and 75%, preferably between 10% and 65% by weight of dry matter of said composition.

Technical Field

The present invention relates to a composition comprising fiber and protein for use in reducing muscle mass loss. The invention also relates to a composition comprising soluble fiber and protein, wherein the ratio of the soluble fiber to the protein is between 5/95 to 75/25 by weight. Thus, the invention also relates to the use of a composition comprising soluble fiber and protein for the preparation of a food or a medicament.

Background

Loss of muscle mass can occur in different situations, such as physical inactivity, chronic diseases (e.g., diabetes, obesity, sarcopenia).

Muscle mass loss is associated with a net balance of protein. Protein net balance (NPB) is defined as Muscle Protein Synthesis (MPS) minus Muscle Protein Breakdown (MPB), or NPB ═ MPS-MPB. Thus, a significant increase in skeletal MPS (anabolism) and/or decrease in MPB (catabolism) such that NPB remaining positive may result in increased skeletal muscle mass accumulation. Conversely, negative NPB resulting from a decrease in MPS and/or an increase in MPB will result in a loss of muscle mass. It has been clearly shown that acute, repeated short-duration, high intensity rounds of intermittent motion of the heavy resistance exercise stimulate a significant increase in MPS.

Aging is characterized by significant changes in body composition, particularly a decrease in muscle mass. The latter phenomenon, recognized as sarcopenia, is a decline in skeletal muscle mass with age. With age, progressive loss of muscle mass can reach up to 11kg between the ages of 30 and 80 years and lead to many functional and metabolic consequences. It is accompanied by a weakening of strength and thus causes loss of autonomy and risks in the elderly. Muscle is a reservoir of amino acids that can move in situations where it is needed. In fact, sarcopenia contributes to a reduction in the ability of elderly people to adapt to environmental stresses (bacterial infections, inflammation) in a proper way. Muscle loss is also involved in the reduction of physical activity and thus in the development of obesity, insulin resistance and osteoporosis in the elderly. Although many mechanisms have been described with respect to the etiology of this syndrome, with age, muscle mass loss is primarily caused by a net loss of protein and thus an imbalance between the rate of muscle protein synthesis and degradation. During aging, resistance to certain anabolic factors occurs, particularly to the stimulation of muscle protein synthesis by dietary intake.

Human food consumption is characterized by its discontinuous nature (2-3 staple foods intermittently throughout the day), thus defining the circadian rhythm of the nutritional state. This consumption profile includes several successive states: postprandial status and postabsorptive status. During the day, various parameters of muscle protein metabolism fluctuate according to a cyclic profile that relates to the nutritional state. During fasting, the balance between synthesis and protein degradation is negative and results in a net loss of protein compensated by an increase in protein in response to food intake (the anabolic period characterized by a positive net balance between protein synthesis rate and protein degradation rate). This alternation between catabolic and anabolic phases allows for the maintenance of protein homeostasis. The decrease in muscle protein mass with age is caused by an imbalance between synthesis and protein degradation that can develop especially during the postprandial period. The increase in protein after meals will no longer compensate for the loss during fasting, and this permanent imbalance will eventually lead to a progressive loss of muscle protein.

Thus, in the case of dietary intake, the muscle protein synthesis rate will be physiologically increased. However, the regulation of food intake is blunted with age and is involved in the progression of sarcopenia.

This hyperaminosis can be obtained by consuming high nutritional value animal proteins (i.e. balanced amino acid composition and rapid digestion). However, epidemiological studies have shown that the consumption of proteins from animal sources (such as meat products) drops dramatically in the elderly. As a result, the manufacture of novel foods for the elderly and the assessment of their nutritional quality can become important over the next decades.

There is therefore still a need to develop compositions with improved physiological and/or pharmacological and/or therapeutic activity to reduce muscle mass loss. It is therefore an object of the present invention to overcome or ameliorate at least one of the disadvantages of the prior art or to provide a useful alternative.

Disclosure of Invention

The present inventors have unexpectedly found that the combination of soluble fibre and protein reduces the loss of muscle mass, preferably the combination of soluble fibre and pea protein.

Accordingly, the present invention relates to a composition comprising soluble fibre and protein for use in reducing loss of muscle mass, preferably in a sarcopenia disorder.

The inventors have found that the compositions of the present invention synergistically increase nitrogen balance and biological value.

In particular, consumption of pea protein with accompanying soluble fibres, such as inulin, causes an increase in (skeletal) muscle mass, which is particularly evident in comparison with pea protein without accompanying soluble fibres.

Furthermore, systemic increases in concentrations of anti-inflammatory factors such as interleukin-10 have been observed without wishing to be bound by theory of one of the mechanisms of action of pea proteins on protein metabolism with or without fibers potentially signaling.

Although the digestibility of pea protein is lower, a significant effect of this protein type on nitrogen balance has been shown, and when pea protein is consumed together with soluble fibres (such as inulin), a higher nitrogen balance is observed. Thus, the retention of pea protein is still effective despite the lower digestibility. This is also evident from the biological value, which is higher for foods with pea proteins and even higher when pea proteins are combined with soluble fibres (such as inulin).

It was further observed that the rate of muscle protein synthesis was increased in the postprandial state compared to the postabsorptive state after administration of pea protein, and the presence of soluble fiber (such as inulin) in the diet could increase the likelihood of postprandial stimulation of muscle anabolism by food proteins, particularly in muscle-reducing subjects. Thus, soluble fibres (such as inulin), in particular in combination with pea protein, allow for an increase in protein synthesis and muscle anabolism. Thus, soluble fibre (such as inulin) increases the effect of pea protein on muscle anabolism and thus increases muscle mass.

In addition, it was shown that after eating pea protein and soluble fiber (such as inulin), the mitochondrial density and enzyme activity was higher, indicating an improvement in the ATP-producing capacity of the muscle.

Nitrogen balance is equal to nitrogen intake minus fecal and urinary nitrogen.

Nitrogen balance was measured by subtracting the excreted nitrogen from the ingested nitrogen. Urine and feces were collected for 48 hours and the food consumption of the animals was measured. Next, the nitrogen content in urine and feces was analyzed and the amount of nitrogen ingested was calculated.

The nitrogen balance was calculated by: uptake of nitrogen-excretion of nitrogen; expressed in g/day.

Nitrogen content (for ingested nitrogen and/or excreted nitrogen) can be determined by the Dumas method (Dumas method). (Dumas, A.Sticks to ffbestimmung. ach Dumas. die Praxis des org. Chemikes (N-Determination to Dumas), 41 th edition; Schrag: N ü rnberg, Germany,1962.)

Biological Value (BV) is a measure of the proportion of proteins absorbed from food that are incorporated into the proteins of an organism. It takes the ease with which the digested protein is used in protein synthesis in the cells of the organism. Protein is the major source of nitrogen in food. BV assumes that the protein is the only source of nitrogen and measures the proportion of absorbed nitrogen that remains in the body.

Biological values are expressed as%.

The Net Protein Utilization (NPU) corresponds to the nitrogen retention rate or the proportion of nitrogen uptake retained in the body. It is determined by the following formula:

NI-nitrogen intake; UN ═ urinary nitrogen; FN ═ fecal nitrogen; EFN ═ endogenous fecal nitrogen; EUN intrinsic urinary nitrogen

Net protein utilization is expressed in%.

The true nitrogen digestibility corresponds to the proportion of absorbed food nitrogen as determined by the rat balance method. It is determined by the following formula:

true digestibility is expressed in%.

Yet another aspect of the invention relates to a composition comprising, consisting essentially of, or consisting of soluble fiber and protein for use in preventing and/or reducing muscle loss.

Yet another aspect of the invention relates to a composition comprising, consisting essentially of, or consisting of soluble fiber and protein for (therapeutically) maintaining or increasing nitrogen balance.

Yet another aspect of the invention relates to a composition comprising, consisting essentially of, or consisting of soluble fiber and protein for (therapeutically) maintaining or increasing the nitrogen balance in a subject suffering from or at risk of muscle loss.

Yet another aspect of the invention relates to a composition comprising, consisting essentially of, or consisting of soluble fiber and protein for (therapeutically) maintaining or increasing nitrogen balance in a subject suffering from physical inactivity, chronic diseases (such as diabetes, obesity, sarcopenia, cachexia).

Yet another aspect of the invention relates to a composition comprising, consisting essentially of, or consisting of soluble fiber and protein for (therapeutically) maintaining or increasing the net protein utilization.

Yet another aspect of the invention relates to a composition comprising, consisting essentially of, or consisting of soluble fiber and protein for use in (therapeutically) maintaining or increasing the net utilization of protein in a subject suffering from or at risk of muscle loss.

Yet another aspect of the invention relates to a composition comprising, consisting essentially of, or consisting of soluble fiber and protein for use (therapeutically) in maintaining or increasing net protein utilization in a subject suffering from physical inactivity, chronic diseases (such as diabetes, obesity, sarcopenia, cachexia).

Yet another aspect of the invention relates to a composition comprising, consisting essentially of, or consisting of soluble fiber and protein for (therapeutically) maintaining or increasing biological value.

Yet another aspect of the invention relates to a composition comprising, consisting essentially of, or consisting of soluble fiber and protein for use in (therapeutically) maintaining or increasing the biological value of a subject suffering from or at risk of muscle loss.

Yet another aspect of the invention relates to a composition comprising, consisting essentially of, or consisting of soluble fiber and protein for use (therapeutically) in maintaining or increasing the biological value of a subject suffering from physical inactivity, chronic diseases (such as diabetes, obesity, sarcopenia, cachexia).

Yet another aspect of the invention relates to the (non-therapeutic) use of a composition comprising, consisting essentially of, or consisting of soluble fibres and proteins for maintaining or increasing the nitrogen balance.

Yet another aspect of the invention relates to the (non-therapeutic) use of a composition comprising, consisting essentially of, or consisting of soluble fiber and protein for maintaining or increasing the nitrogen balance in a subject suffering from or at risk of muscle loss.

Yet another aspect of the invention relates to the (non-therapeutic) use of a composition comprising, consisting essentially of, or consisting of soluble fiber and protein for maintaining or increasing the nitrogen balance in a subject suffering from physical inactivity, chronic diseases (such as diabetes, obesity, sarcopenia, cachexia).

Yet another aspect of the invention relates to the (non-therapeutic) use of a composition comprising, consisting essentially of, or consisting of soluble fiber and protein for maintaining or increasing the net protein utilization.

Yet another aspect of the invention relates to the (non-therapeutic) use of a composition comprising, consisting essentially of, or consisting of soluble fiber and protein for maintaining or increasing the net utilization of protein in a subject suffering from or at risk of muscle loss.

Yet another aspect of the invention relates to the (non-therapeutic) use of a composition comprising, consisting essentially of, or consisting of soluble fiber and protein for maintaining or increasing the net utilization of protein in a subject suffering from physical inactivity, chronic diseases (such as diabetes, obesity, sarcopenia, cachexia).

Yet another aspect of the invention relates to the (non-therapeutic) use of a composition comprising, consisting essentially of, or consisting of soluble fibres and proteins for maintaining or increasing biological value.

Yet another aspect of the invention relates to the (non-therapeutic) use of a composition comprising, consisting essentially of, or consisting of soluble fiber and protein for maintaining or increasing the biological value of a subject suffering from or at risk of muscle loss.

Yet another aspect of the invention relates to the (non-therapeutic) use of a composition comprising, consisting essentially of, or consisting of soluble fiber and protein for maintaining or increasing biological value in a subject suffering from physical inactivity, chronic diseases (such as diabetes, obesity, sarcopenia, cachexia).

Yet another aspect of the invention relates to a method of maintaining or increasing nitrogen balance comprising administering a composition comprising, consisting essentially of, or consisting of soluble fiber and protein.

Yet another aspect of the invention relates to a method of maintaining or increasing nitrogen balance in a subject having or at risk of muscle loss comprising administering a composition comprising, consisting essentially of, or consisting of soluble fiber and protein.

Yet another aspect of the invention relates to a method for maintaining or increasing nitrogen balance in a subject suffering from physical inactivity, chronic diseases (such as diabetes, obesity, sarcopenia, cachexia) comprising administering a composition comprising, consisting essentially of, or consisting of soluble fiber and protein.

Yet another aspect of the invention relates to a method of maintaining or increasing net protein utilization comprising administering a composition comprising, consisting essentially of, or consisting of soluble fiber and protein.

Yet another aspect of the invention relates to a method of maintaining or increasing the net rate of protein utilization in a subject having or at risk of muscle loss, comprising administering a composition comprising, consisting essentially of, or consisting of soluble fiber and protein.

Yet another aspect of the invention relates to a method of maintaining or increasing net protein utilization in a subject having physical inactivity, a chronic disease (e.g., diabetes, obesity, sarcopenia, cachexia) comprising administering a composition comprising, consisting essentially of, or consisting of soluble fiber and protein.

Yet another aspect of the invention relates to a method of maintaining or increasing biological value comprising administering a composition comprising, consisting essentially of, or consisting of soluble fiber and protein.

Yet another aspect of the invention relates to a method of maintaining or increasing the biological value of a subject having or at risk of muscle loss comprising administering a composition comprising, consisting essentially of, or consisting of soluble fiber and protein.

Yet another aspect of the invention relates to a method for maintaining or increasing the biological value of a subject suffering from physical inactivity, chronic diseases (such as diabetes, obesity, sarcopenia, cachexia) comprising administering a composition comprising, consisting essentially of, or consisting of soluble fiber and protein.

Yet another aspect of the invention relates to a composition comprising, consisting essentially of, or consisting of soluble fiber and protein, wherein the ratio of soluble fiber/protein ranges from 5 wt%/95 wt% to 75 wt%/25 wt%, such as from 5 wt%/95 wt% to 75 wt%/25 wt% or from 20 wt%/80 wt% to 50 wt%/50 wt%.

The invention also encompasses a food or beverage product or food supplement comprising between 0.1 and 40g, such as between 5 and 30g, of a composition according to the invention per serving of the food or beverage product or food supplement, or comprising between 5% and 75%, preferably between 10% and 65%, by weight of dry matter, of a composition according to the invention.

The invention also covers the use of a composition according to the invention as a food additive in the manufacture of a food or beverage product or food supplement comprising between 0.1 and 40g, such as between 5 and 30g, of the composition per serving of the food or beverage product or food supplement, or comprising between 5% and 75%, preferably between 10% and 65%, by weight of dry matter, of the composition according to the invention.

The present invention also encompasses a food or beverage product or food supplement according to the present invention as described herein for use in preventing and/or reducing muscle loss.

Drawings

Figure 1 shows a graph plotting the effect of whey protein, pea protein and a mixture of inulin and protein on nitrogen balance according to an embodiment of the invention.

Figure 2 shows a graph plotting the effect of whey protein, pea protein and a mixture of inulin and protein on nitrogen true digestion according to an embodiment of the invention.

Figure 3 shows a graph plotting the effect of whey protein, pea protein and a mixture of inulin and protein on the net protein utilization according to an embodiment of the invention.

Figure 4 shows a graph plotting the effect of whey protein, pea protein and a mixture of inulin and protein on biological value according to an embodiment of the invention.

Detailed Description

The invention is here particularly derived from any one or any combination of the following aspects and implementations and one or more of the numbered statements 1 to 43.

1. A composition comprising soluble fibre and protein for use in preventing and/or reducing loss of muscle mass, increasing nitrogen balance, increasing net protein utilization and/or increasing biological value.

2. The composition according to statement 1, wherein the composition comprises at least 7 wt.% soluble fiber on a dry matter basis.

3. The composition according to statement 1 or 2, wherein the composition comprises at least 10 wt.% protein on a dry matter basis.

4. The composition according to any of statements 1 to 3, wherein the ratio of the soluble fiber to the protein is between 5/95 to 75/25 by weight.

5. The composition according to any one of statement 1 to 4, wherein the soluble fiber is inulin.

6. The composition according to statement 5, wherein the inulin has an average polymerization degree value of less than 50.

7. The composition according to statement 5 or 6, wherein the inulin has an average polymerization degree value of at least 2.

8. The composition according to statement 5 to 7, wherein the inulin is obtained from a plant selected from the group comprising: elecampane (elecampane), dandelion (dandelion), dahlia (dahlia), wild yam (wild yam), artichoke (artichoke), Jerusalem artichoke (Jerusalem artichoke), chicory (chicory), yam (jicama), burdock (burdock), onion, garlic, agave (agave), yacon (yac fig), banana, leek, asparagus, clematis (camas) or a mixture thereof.

9. The composition according to any one of statement 1 to 8, wherein the protein is selected from the group consisting of animal proteins, plant proteins, alone or in mixtures thereof.

10. The composition according to statement 9, wherein the protein is preferably a vegetable protein.

11. The composition according to statement 9 or 10, wherein the plant protein is a pulse protein.

12. The composition according to any one of statement 9 to 11, wherein the protein is pea protein.

13. The composition according to statement 9, wherein the protein is preferably an animal protein.

14. The composition according to statement 13, wherein the animal protein is preferably whey protein.

15. Composition according to any of statements 1 to 14, wherein the loss of muscle mass is caused by insufficient physical activity, chronic diseases (such as diabetes, obesity, sarcopenia, cachexia).

16. The composition according to statement 15, wherein the loss of muscle mass is caused by sarcopenia.

17. The composition according to statement 15 or 16, wherein the loss of muscle mass is caused by insufficient physical activity.

18. The composition according to any one of statements 15 to 17, wherein the loss of muscle mass is caused by diabetes.

19. The composition according to any one of statements 15 to 18, wherein the loss of muscle mass is caused by type I diabetes.

20. The composition according to any one of statements 15 to 18, wherein the loss of muscle mass is caused by type II diabetes.

21. The composition according to any one of statements 15 to 18, wherein the loss of muscle mass is caused by obesity.

22. The composition according to any one of statements 1 to 21, wherein the soluble fiber and the protein have a synergistic effect.

23. The composition according to any one of statement 1 to 22, wherein the composition is used in human food.

24. A composition comprising soluble fiber and protein, wherein the ratio of the soluble fiber to the protein is between 5/95 to 75/25 by weight.

25. The composition according to statement 24, wherein the composition comprises at least 7 wt.% soluble fiber on a dry matter basis.

26. The composition according to statement 24 or 25, wherein the composition comprises at least 10 wt.% protein on a dry matter basis.

27. The composition according to any one of statement 24 to 26, wherein the soluble fiber is inulin.

28. The composition according to statement 27, wherein the inulin has an average polymerization degree value of less than 50.

29. The composition according to statement item 27 or 28, wherein the inulin has an average polymerization degree value of at least 3.

30. The composition according to any of statements 27 to 29, wherein the inulin is obtained from a plant selected from the group comprising: elecampane, dandelion, dahlia, wild yam, artichoke, jerusalem artichoke, chicory, burdock, onion, garlic, agave, yacon, banana, leek, asparagus, clematis terniflora or a mixture thereof.

31. The composition according to statement 24, wherein the protein is selected from the group consisting of animal proteins, plant proteins, alone or in mixtures thereof.

32. The composition according to statement 31, wherein the protein is preferably a vegetable protein.

33. The composition according to statement 31 or 32, wherein the plant protein is a legume protein.

34. The composition according to any of statements 31 to 33, wherein the protein is pea protein.

35. The composition according to statement 31, wherein the protein is preferably an animal protein.

36. The composition according to statement 35, wherein the animal protein is preferably whey protein.

37. The composition according to statement 1 to 36, comprising at least 65 wt.%, preferably at least 75 wt.%, more preferably at least 85 wt.%, even more preferably at least 95 wt.%, most preferably at least 98 wt.% protein and soluble fiber on a dry matter basis.

38. A food or beverage product or food supplement comprising between 0.1 and 40g of the composition according to any one of the statement 1 to 37, preferably per serving of the food or beverage product or food supplement.

39. A food or beverage product or food supplement comprising between 5 and 75 wt.%, preferably between 10 and 65 wt.% of the composition according to any one of the statement 1 to 37 on a dry matter basis.

40. A food or beverage product or food supplement according to statement item 38 or 39, comprising between 0.5 and 30 wt.% of soluble fiber on a dry matter basis (i.e. the soluble fiber as defined in statement items 1-37).

41. A food or beverage product or food supplement according to statement 38 or 39 comprising between 5 and 50 wt.% protein on a dry matter basis (i.e. the protein as defined in statement 1-37).

42. A food or beverage product or food supplement according to statement item 38 or 39, comprising between 0.5 and 30 wt.% of soluble fibre on a dry matter basis (i.e. the soluble fibre as defined in statement items 1-37) and comprising between 5 and 50 wt.% of protein on a dry matter basis (i.e. the protein as defined in statement items 1-37).

43. Use of a composition according to any of the statements 1 to 37 as ingredient, food additive or feed additive in the manufacture of a food or beverage product or food supplement, optionally comprising between 0.1 and 40g of said composition per serving of said food or beverage product or food supplement, or comprising between 5 and 75 wt.%, preferably between 10 and 65% of said composition on a dry matter basis.

Before the present methods are described, it is to be understood that this invention is not limited to the particular methodology, components, products, or combinations described, as such methodologies, components, products, and combinations can vary. It is also to be understood that the terminology used herein is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

As used herein, the singular forms "a", "an" and "the" include singular and plural references unless the context clearly dictates otherwise.

The terms "comprising" and "consisting of … …" as used herein are synonymous with "including" or "containing" and are closed or open-ended and do not exclude additional unrecited members, elements or method steps. It will be understood that the terms "comprising" and "consisting of … …" as used herein include terms "consisting of … …" and the term "consisting essentially of … …".

The recitation of numerical ranges by endpoints includes all numbers and fractions subsumed within that respective range, as well as the recited endpoint.

The term "about" as used herein when referring to measurable values such as parameters, amounts, time intervals, and the like, is meant to encompass variations that are and are +/-20% or less, preferably +/-10% or less, more preferably +/-5% or less, and even more preferably +/-1% or less, relative to the specified values, provided such variations are suitable for performance in the disclosed invention. It is to be understood that the value to which the modifier "about" or "approximately" refers is itself also specifically and preferably disclosed.

In view of the fact that the term "one or more" or "at least one" (such as one or more members or at least one member of a group of members) makes itself clear by way of further example, this term especially covers the references to: any one of the members or any two or more of the members, such as any ≧ 3, ≧ 4, ≧ 5, ≧ 6 or ≧ 7 or the like for the member, and up to all of the members.

All references cited in this specification are incorporated herein by reference in their entirety. In particular, the teachings of all references specifically mentioned herein are incorporated by reference.

Unless defined otherwise, all terms used in disclosing the invention, including technical and scientific terms, have the meaning as commonly understood by one of ordinary skill in the art. By way of further guidance, definitions of terms are included to provide a better understanding of the teachings of the present invention.

In the following paragraphs, the different aspects of the invention are defined in more detail. Unless expressly indicated to the contrary, aspects so defined may be combined with any other aspects. In particular, any feature indicated as being preferred or advantageous may be combined with any other feature or features indicated as being preferred or advantageous.

Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment but may. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments, as will be apparent to those of ordinary skill in the art from this disclosure. Furthermore, when some embodiments described herein include some features rather than other features included in other embodiments, combinations of features of different embodiments are intended to be within the scope of the invention and form different embodiments, as would be understood by those skilled in the art. For example, in the following claims, any of the claimed implementations may be used in any combination.

The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.

As used herein, the expression "%" refers to "% by weight expressed on a dry matter basis". The% may be calculated based on the total composition according to the invention. Alternatively, the% may be calculated from the ratio between two or more compounds of the mixture.

The present invention relates to compositions comprising soluble fiber and protein, such as compositions comprising soluble fiber and protein for reducing muscle mass loss.

In certain embodiments, the composition comprises at least 7 wt.% soluble fiber, preferably 10 wt.%, more preferably 25 wt.%, even more preferably 45 wt.% soluble fiber.

In certain embodiments, the composition comprises at least 10 wt.% soluble fiber, preferably 25 wt.%, more preferably 50 wt.%, even more preferably 60 wt.% protein.

In certain embodiments, the composition comprises at least 5 wt.% soluble fiber, based on the total amount of protein and soluble fiber.

In certain embodiments, the composition comprises up to 75 wt.% soluble fiber, based on the total amount of protein and soluble fiber.

In certain embodiments, the composition comprises at least 25% protein by weight, based on the total amount of protein and fiber.

In certain embodiments, the composition comprises up to 95% protein by weight, based on the total amount of protein and fiber.

In certain embodiments, the composition comprises at least 5 wt.% soluble fiber on a dry matter basis.

In certain embodiments, the composition comprises up to 75 wt.% soluble fiber on a dry matter basis.

In certain embodiments, the composition comprises at least 25 wt.% protein on a dry matter basis.

In certain embodiments, the composition comprises up to 95% by weight protein on a dry matter basis.

In certain embodiments, the composition comprises a soluble fiber/protein weight ratio of between 5/95 and 75/25, preferably between 20/80 and 75/25, more preferably between 25/75 and 50/50.

In certain embodiments, the composition comprises at least 65 wt.% protein and soluble fiber on a dry matter basis, preferably at least 75 wt.%, more preferably at least 85 wt.%, even more preferably at least 95 wt.%, most preferably at least 98 wt.%.

In the present invention, the term "soluble fiber" means soluble dietary fiber. The fibers represent an entire series of different compounds with the common property of not being decomposable by human digestive enzymes. Almost all dietary fibers are carbohydrate polymers.

Preferably, the soluble fiber of plant origin is selected from the group consisting of: fructans, including Fructooligosaccharides (FOS) and inulin; glucooligosaccharides (GOS), Arabinoxylans (AX), arabinoxylan-oligosaccharides (AXOS), isomalto-oligosaccharides (IMO), trans-galactooligosaccharides (TOS), pyrodextrins, polydextrose, branched maltodextrins, indigestible dextrins and soluble oligosaccharides derived from oily plants or plants producing proteins.

The term "soluble fiber" is intended to mean a fiber that is soluble in water. The fibers can be analyzed according to various AOAC methods. For example, mention may be made of AOAC methods 997.08 and 999.03 for fructans, FOS and inulin, AOAC method 2000.11 for polydextrose, AOAC method 2001.03 for the analysis of fibers contained in branched maltodextrins and indigestible dextrins, or AOAC method 2001.02 for GOS and soluble oligosaccharides derived from oily plants or protein producing plants. Among the soluble oligosaccharides derived from oleaginous plants or protein producing plants, mention may be made of soy, rapeseed or pea oligosaccharides.

According to a preferred embodiment of the invention, the composition comprises inulin and protein.

According to a preferred embodiment of the invention, the composition comprises soluble fibre and pea protein.

According to a preferred embodiment of the invention, the composition comprises inulin and pea protein.

According to a preferred embodiment of the invention, the composition comprises inulin and protein for reducing muscle mass loss.

According to a preferred embodiment of the invention, the composition comprises soluble fibre and pea protein for reducing loss of muscle mass.

According to a preferred embodiment of the invention, the composition comprises inulin and pea protein for reducing muscle mass loss.

In certain embodiments, the protein (such as pea protein) is a protein extract, such as pea protein extract. The extract preferably comprises at least 80 wt.%, preferably at least 85 wt.%, such as at least 90 wt.% of protein (such as pea protein) on a dry matter basis.

In certain embodiments, the soluble fiber (such as inulin) is a soluble fiber extract, such as an inulin extract. The extract preferably comprises at least 80 wt.% soluble fibre (such as inulin), preferably at least 85 wt.%, more preferably at least 90 wt.%, such as at least 95 wt.%, on a dry matter basis.

As used herein, the term "inulin" refers to a mixture of oligosaccharides and/or polysaccharides of fructose, which may have terminal glucose. Inulin belongs to a class of fibers known as fructans. In one embodiment, inulin may be represented by the general formulae GFn and Fm according to the terminal carbohydrate unit, wherein G represents a glucose unit, F represents a fructose unit, n is an integer representing the number of fructose units linked to said terminal glucose unit, and m is an integer representing the number of fructose units linked to each other in said carbohydrate chain. The inulin used in the present invention encompasses inulin having terminal glucose, which is also referred to as α -D-glucopyranosyl- [ β -D-fructofuranosyl ]) (n-1) -D-fructofuranose side, and inulin free of glucose, which is also referred to as β -D-fructofuranosyl- [ D-fructofuranosyl ] (n-1) -D-fructofuranose side. Inulin for use in the present invention may also encompass hydrolysis products of inulin such as fructooligosaccharides, which are fructo-oligomers having a Degree of Polymerization (DP) ≦ 20, and it may also encompass fructo-oligomers synthesized from sucrose ending with a terminal glucose, which have a DP of 3 to 5. Suitable oligosaccharide chains of inulin derived from plant sources for use in the present invention may have a Degree of Polymerisation (DP) in the range of from 3 to about 100. Inulin may be a liquid or a powder product.

As used herein, the term "degree of polymerization" or "(DP)" relates to the number of monosaccharide residues present in an oligosaccharide or polysaccharide. The parameter average degree of polymerization is also typically used. The degree of polymerization is a measure of Molecular Weight (MW). DP can be calculated as the ratio of the total MW of the polymer or oligomer to the MW of the repeat unit.

In a particular embodiment, the composition comprises inulin for reducing muscle mass loss and protein, the inulin having an average DP of less than 50, such as between 2 and 40, such as between 2 and 30, such as between 5 and 20, such as between 5 and 15, and for example being about 10, in value.

In one embodiment, the inulin for use in the composition may be derived or isolated or obtained from any natural source of inulin known to date, or may be enzymatically synthesized from sucrose, or may be commercially available inulin. In one embodiment, the inulin is derived from or isolated from: elecampane, dandelion, dahlia, wild yam, artichoke, jerusalem artichoke, chicory, yam bean, burdock, onion, garlic, agave, yacon, banana, liquorice, banana, liquorice root, pine nut and pine nut,Leek, asparagus, kemeilian. In one embodiment, the inulin is (largely) linear fibres. Preferably, the inulin is derived from or isolated from chicory or jerusalem artichoke. Suitable commercial inulins for use in the present invention may be selected from the group comprising:Instant、 … (Cosucra Group shipping SA, Belgium), … (Sensus, the Netherlands), … (Beneo-Orafti, Belgium), … (Syral, France).

In a preferred embodiment, the inulin for use in the composition is derived from chicory or jerusalem artichoke and has an average DP between 6 and 25.

In a preferred embodiment, the composition comprises soluble fiber and vegetable protein for reducing muscle mass loss.

In the present invention, the term "vegetable protein" preferably encompasses all proteins derived from cereals, oleaginous plants, tubers and legumes, and may be used alone or in a mixture.

In the present invention, the term "cereal" is intended to mean a cultivated plant of the family gramineae that produces edible seeds. Non-limiting examples are wheat, oat, rye, barley, corn, sorghum, chestnut or rice. Cereals are often ground in the form of flour, but they can also be obtained in the form of granules and sometimes in the form of whole plants (feed).

In the present invention, the term "oily plant" means a plant, the seeds of which are specifically planted or the fruits of which are rich in fat, from which an oil for dietary, energy or industrial use is extracted. Non-limiting examples are rapeseed oil, peanut oil, sunflower oil, soybean oil, sesame oil and castor oil plants.

In the present invention, the term "tuber plant" is intended to mean all plants comprising storage organs, usually underground, which ensure the survival of the plants during the winter season and which are usually propagated by vegetative (vegetative) processes. These organs expand due to the accumulation of stored substances. The organs converted into tubers may be:

root: non-limiting examples are carrot, parsnip, cassava, konjac,

rootstock: non-limiting examples are potato, jerusalem artichoke, Japanese artichoke, sweet potato,

base of stem (more particularly hypocotyl): non-limiting examples are kohlrabi (kohlrabi), root celery (celeriac),

root + hypocotyl combination: non-limiting examples are beet, radish.

In a preferred embodiment, the composition comprises soluble fiber and pulse protein for reducing loss of muscle mass.

In a preferred embodiment, the composition comprises inulin and pulse protein for reducing muscle mass loss.

In the present invention, the term "legume" is intended to mean a dried seed of a leguminous plant. The four most common legumes are beans, chickpeas, lentils, and peas. Dolichees (e.g. Lentils (Lens Culinaris) including, for example, white whale Lentils (Beluga Lentils), Brown Lentils (Brown Lentils), French Green Lentils (French Green Lentils), Green Lentils (Green Lentils) and Red Lentils (Red Lentils). Phaseolus Vulgaris (e.g. Phaseolus Vulgaris) including, for example, Ormosia (Adzuki Bean), Pinto Bean (Ananaszi Bean), Apanarusalem Bean (Apalosa Bean), Baby cottage Bean (Baby Lima Bean), Black blue Bean (Black Calypso Bean), Black tortoise Bean (Black Turtle Bean), Dark Red Kidney Bean (Dark Red Kidney Bean), white Kidney Bean (Green Northern Bean), respective Red Yahoo Bean (Jab' Kidney Bean), Red Kidney Bean (Bean), Red Bean (Bean), white Kidney Bean (Bean), Red Bean (grass), Red Bean (corn Bean), Red Bean (corn Bean), Red Bean (corn Bean), corn Bean (corn Bean), corn Bean (corn Bean), corn Bean (corn Bean), corn Bean (corn Bean), corn Bean (corn Bean), corn Bean (corn Bean), corn Bean (corn Bean), corn Bean (corn Bean), corn Bean (corn Bean), corn Bean (corn Bean), corn Bean (corn Bean), corn Bean (corn Bean), corn Bean (corn Bean), corn Bean (corn Bean), corn Bean (corn Bean, The Cantonese Bean (Tongue of Fire), White Kidney Bean (White Kidney Bean), and Navy Bean (White Navy Bean). Peas (e.g., peas (Pisum sativum)) include, for example, Black-Eyed peas (Black-Eyed peas), Green peas (Green peas), big-creped peas (Marrowfat peas), Pigeon peas (Pigeon peas), Yellow peas (Yellow peas), and Yellow-Eyed peas (Yellow-Eyed peas). Chickpeas (e.g., chickpeas (Cicer Arietinum)) include, for example, chickpeas (Chickpea) and chickpeas (Kabuli).

In a preferred embodiment, the composition comprises soluble fibre and pea protein for reducing loss of muscle mass.

In a most preferred embodiment, the composition comprises inulin and pea protein for reducing the loss of muscle mass.

In a most preferred embodiment, pea protein is used. The dried peas contain 20-30% lysine-rich protein. Pea proteins are mainly storage proteins consisting of albumin and two globulins (legumin and bombycinin), which can be relatively easily dissolved and separated. In addition, these proteins are characterized by a higher lysine content, which is deficient in many other proteins of plant origin. The solubility profile of pea protein isolates is similar to other legume proteins and is characterized by high solubility at alkaline pH, minimal solubility at the isoelectric point, and moderate solubility in acidic media. It is characterized by relatively good emulsifying activity.

Pea proteins can be prepared in three forms: pea meal, pea protein concentrate, and pea protein isolate. Pea flour is produced by drying ground dehulled peas. Pea protein concentrate can be produced via conventional acid leaching procedures used to make soy protein concentrate, but is more economical using a dry separation process. Pea protein isolate was produced by a wet treatment process.

Proteins and starches from non-oilseed legumes such as peas can be efficiently separated by dry grinding and air fractionation. The fine grinding produces a flour containing a population of particles differentiated by size and density. Air fractionation of this flour separates the protein (fine fraction) from the starch (coarse fraction). In this drying process, whole or dehulled peas are needle milled into very fine flour. During milling, the starch granules remain fairly intact, while the protein matrix breaks down into fine particles. Grinding must be done carefully to avoid damage to the starch granules. The flour is air fractionated in a spiral air flow into a fine fraction containing about 75% of the total protein but only 25% of the total mass; and a coarse fraction containing a majority of the starch granules. The starch and protein fractions are separated in an air classifier based on their mass and size differences. The coarse fraction may be centrifuged from the fine fraction and carried into a coarse fraction conduit. The fines fraction was carried with air into an air cyclone. After milling, some of the protein bulk remains adhered to the starch granules and some of the starch remains embedded in the protein matrix. The content of adherent protein bodies and agglomerated starch and protein can be reduced by repeated needle milling and air classification. In this two-pass process, a yield of 33-35% of the total protein fraction (protein content 56%, N × 6.25 on a dry weight basis) was obtained for peas, with an original protein content of about 25%.

The highly concentrated protein fraction (protein isolate) and the pea protein concentrate can be prepared by a wet process. Protein separation is mainly based on protein solubilization followed by isoelectric precipitation for subsequent recovery.

Isoelectric precipitation methods for protein isolate production involve grinding peas followed by dissolution of the protein in water, alkali or acid; followed by centrifugation to remove insoluble components. The solubilized protein is then precipitated at its isoelectric pH. The precipitated protein curd is collected by centrifugation or sieving. The curd is dried to produce an isoelectric protein isolate, or neutralized and dried to produce a cationic protein isolate.

The protein isolate has a total protein content (expressed as N6.25) of at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, for example between 70% and 99%, preferably between 80% and 95%, more preferably between 80% and 90% on a dry matter basis. In a preferred embodiment, pea protein isolate is used.

In a preferred embodiment, unhydrolyzed vegetable protein is used. The term "unhydrolyzed protein" is equivalent to "intact" protein, meaning that the protein has not undergone a hydrolysis process. However, small amounts of hydrolyzed protein may be present in the source of unhydrolyzed protein or may be added to the formulation, such as additional amino acids, such as leucine, isoleucine, glutamine, arginine, or dipeptides, and analogs thereof. According to another embodiment, the intact protein may have a Degree of Hydrolysis (DH) of only 5% or less, preferably 4%, 3%, 2%, 1% or less.

In one embodiment, the composition comprises soluble fiber and animal protein for reducing loss of muscle mass, and may be selected from whey protein, casein or egg protein, alone or in combination.

In a preferred embodiment, the composition comprises soluble fiber and whey protein for reducing loss of muscle mass.

Thus, the invention also encompasses compositions consisting of soluble fiber and protein and their use for reducing loss of muscle mass, such as physical inactivity, chronic diseases (e.g. diabetes, obesity and sarcopenia). Preferably, the composition of the invention is used to reduce the loss of muscle mass in sarcopenia.

As used herein, the term "synergistic effect" or "synergy" refers to two or more agents acting together to produce a result that is not independently obtainable by any agent. This term is used to describe the situation where different entities advantageously cooperate for the end result. As used herein, the term "synergistic amount (synthetic/synthetic) refers to the amount of inulin and protein that together achieve a more pronounced effect than each alone or even achieve an effect that is greater than the sum of each alone.

The present inventors have surprisingly found that soluble fiber and protein have a synergistic effect in reducing loss of muscle mass, particularly in sarcopenia. In a particular embodiment, the present invention provides a composition comprising soluble fiber and protein, wherein the soluble fiber and protein are present in synergistic amounts. Thus, the compositions offer great potential to better increase nitrogen balance and biological value.

The present invention relates to a composition comprising soluble fibre and protein, wherein the ratio of the soluble fibre to the protein is between 5/95 to 75/25, preferably 20/80 and 75/25, more preferably 25/75 and 50/50 by weight.

In certain embodiments, the composition comprises at least 7 wt.% soluble fiber, preferably 10 wt.%, more preferably 25 wt.%, even more preferably 45 wt.% soluble fiber.

In certain embodiments, the composition comprises at least 10 wt.% soluble fiber, preferably 25 wt.%, more preferably 50 wt.%, even more preferably 60 wt.% protein.

In one embodiment, the composition comprises inulin and pea protein, wherein the ratio of said soluble fiber to said protein is between 5/95 and 50/50 by weight.

In a particular embodiment, the composition comprises inulin and protein, the inulin having an average DP of less than 50 in number, such as between 2 and 50, such as between 2 and 40, such as between 2 and 30, such as between 5 and 20, such as between 5 and 15, and for example being about 10.

In a preferred embodiment, the inulin in the composition is derived from chicory or jerusalem artichoke and has an average DP between 6 and 25.

In a preferred embodiment, the composition comprises soluble fiber and vegetable protein, wherein the ratio of the soluble fiber to the protein is between 20/80 to 50/50 by weight.

In a preferred embodiment, the composition comprises soluble fiber and pulse protein, wherein the ratio of the soluble fiber to the protein is between 5/95 to 75/25 by weight.

In a preferred embodiment, the composition comprises inulin and pulse protein, wherein the ratio of the soluble fiber to the protein is between 5/95 to 75/25 by weight.

In a preferred embodiment, the composition comprises soluble fibre and pea protein, wherein the ratio of said soluble fibre to said protein is between 5/95 and 75/25 by weight.

In a most preferred embodiment, the composition comprises inulin and pea protein, wherein the ratio of said soluble fibre to said protein is between 5/95 and 75/25 by weight.

In one embodiment, the composition comprises soluble fiber and animal protein, wherein the ratio of the soluble fiber to the protein is between 5/95 to 75/25 by weight and may be selected from whey protein, casein or egg protein, alone or in combination.

In a preferred embodiment, the composition comprises soluble fibre and whey protein, wherein the ratio of the soluble fibre to the protein is between 5/95 to 75/25 by weight.

Thus, the present invention also relates to the use of a composition according to the invention as described herein, comprising, consisting essentially of or consisting of soluble fibres and proteins, for the preparation of a food, beverage or (food/beverage) supplement, and/or for a medicament for reducing muscle mass loss, preferably in the case of sarcopenia (the food, beverage or (food/beverage supplement) may be a medicament). The present invention also relates to a method for reducing muscle mass loss in a subject in need thereof, comprising administering a physiologically or therapeutically effective amount of a composition according to the invention as described herein, comprising, consisting of or consisting essentially of soluble fiber and protein.

The present invention relates to a composition according to the invention as described herein comprising, consisting essentially of or consisting of soluble fiber and protein, and its use for reducing loss of muscle mass. The present invention also relates to a composition comprising, consisting essentially of, or consisting of soluble fiber and protein, wherein the ratio of the soluble fiber to the protein is between 5/95 to 75/25 by weight. As used herein, the term "comprising" means that the composition contains at least soluble fiber and protein. Other compounds, ingredients, products may or may not be present in such compositions. Non-limiting examples of other ingredients include other fermentable fibers, carbohydrates, proteins, fats, minerals, vitamins.

As used herein, the term "therapeutically effective amount" of the above-described compositions as described above relates to the amount or quantity of the composition required to achieve the desired therapeutic and/or prophylactic effect. An effective amount can be measured and expressed in g/day.

As used herein, the term "physiologically effective amount" of the above-described composition relates to the amount or quantity of the composition required to achieve the desired physiological effect. An effective amount can be measured and expressed in g/day.

The composition according to the invention can be supplemented to foods, such as functional foods, nutritive foods and/or food supplements, as a food additive, in particular a functional food additive. The present invention also encompasses a method for preparing a food or beverage or food supplement comprising the steps of: (a) providing a composition according to the invention and (b) formulating said composition into a food product, a feed product, a beverage or a supplement.

The invention also relates to food products containing the composition according to the invention, as well as to feed products containing the same composition, beverages containing the same composition and food supplements containing the same composition.

The composition of the invention can be used as a food additive in the production of food or beverages, or as a matrix for food supplements. In one embodiment, the food or beverage or supplement comprises between 0.1 and 40g of the composition according to the invention per serving of said food or beverage or supplement. In a preferred embodiment, the food or beverage or supplement comprises between 0.5 and 20g of the composition according to the invention per serving of said food or beverage or supplement. In an even more preferred embodiment, the food or beverage or supplement comprises between 1 and 10g of the composition according to the invention per serving of said food or beverage or supplement.

It is to be understood that a food, beverage, or supplement may pertain to a food, beverage, or supplement ready for consumption, but may also pertain to a food, beverage, or supplement portion, concentrate, or the like that may need to be reconstituted or otherwise processed in order to obtain a food, beverage, or supplement ready for consumption (e.g., a ready-to-eat powder, dough, etc.).

For pharmaceutical use, the compositions of the invention may be formulated as a pharmaceutical preparation comprising soluble fiber and protein, and at least one pharmaceutically acceptable carrier, diluent or excipient and/or adjuvant, and optionally one or more other pharmaceutically active compounds. Such formulations may be in a form suitable for oral administration.

In one embodiment, the compositions of the present invention may be optionally combined with at least one pharmaceutically acceptable carrier for oral administration. When combined with a carrier, the weight percentage of carrier on the total composition may be between 1 and 85%. Typical carriers are food and water. If soluble fiber is used, the combination of the aqueous carrier and the soluble fiber will be a solution. If insoluble fibers are used, the combination of the aqueous carrier and the fibers will be a suspension. The composition may comprise an inert diluent or an edible carrier. It can be encapsulated in gelatin capsules or compressed into tablets. For the purpose of oral therapeutic administration, the compositions may be incorporated with excipients and used in the form of tablets, lozenges, suppositories, or capsules. Pharmaceutically compatible binding agents and/or adjuvant materials may be included as part of the composition. Tablets, pills, capsules, lozenges and the like may contain any of the following ingredients or compounds with similar properties: binders such as microcrystalline cellulose, gum tragacanth or gelatin; excipients, such as starch or lactose; disintegrating agents, such as alginic acid, sodium starch glycolate or corn starch; lubricants, such as magnesium stearate or Sterotes; glidants such as colloidal silicon dioxide; sweetening agents, such as sucrose or saccharin; or a flavoring agent such as peppermint, methyl salicylate, or orange flavoring. When the unit dosage form is a capsule, it may contain, in addition to materials of the above type, a liquid carrier such as a fatty oil. In addition, the unit dosage form may contain various other materials which modify the physical form of the unit dosage form, such as sugar coatings, shellacs, or enteric agents. The compositions may be administered as components of elixirs, suspensions, syrups, wafers, chewable lozenges and the like. In addition to the active compounds, syrups may contain sucrose as a sweetening agent, and certain preservatives, dyes and colorings and flavors. The composition may also be mixed with other active substances which do not impair the desired action or with substances which supplement the desired action.

The pharmaceutical preparation is preferably in unit dosage form and may be suitably packaged, for example, in a box, blister, vial, bottle, sachet, ampoule or any other suitable single or multiple dose holder or container (which may be appropriately labeled); optionally together with one or more pages of leaflet material containing product information and/or instructions for use.

The compositions of the present invention will generally be administered in an effective amount sufficient, after appropriate administration, to achieve the desired physiological, therapeutic and/or prophylactic effect in the subject to which they are administered. It will be further understood that for any particular subject, the particular dosage regimen will be adjusted over time according to the needs of the subject and the professional judgment of the person administering or supervising the administration of the composition, and that the dosage ranges set forth herein are exemplary only and are not intended to limit the scope or practice of the composition.

The invention will now be aided by the following examples, which are not intended to limit the scope of the invention in any way.

Examples

1. Materials and methods

1.1. Product(s)

The standard diet consisted of protein in the form of 6% fat (soybean oil), 80% carbohydrates (10% sucrose, 40.6% starch, 15.5% maltodextrin and 8.3% cellulose) and 14% casein (7.5% moisture).

For comparison, 2 types of proteins were used: whey protein and pea protein.

The source of pea protein in this test was(COSUCRA group Warcoding SA, Belgium), a pea protein isolate with 95 wt% +/-2% dry matter and 86 +/-2% protein content.

The source of inulin used in this experiment wasInstant (cosuscar group shipping SA, belgium), which is chicory inulin having a DP in the range of 2 to 60 and an average DP (in number) of about 10.Instant is a powder with 96% dry matter and 90% inulin on dry matter.

1.2. Test subject

Rats were delivered to our animal facility 2 weeks prior to the start of the study in order to acclimatize to the new environment. Throughout the study, rats were placed in individual cages in a controlled environment, i.e., light (12 hours light, 12 hours night), temperature (20-22 ℃) and a dipstick (50-60% humidity). Rats were fed a ceramic feeder designed to prevent food loss. Animals and food were weighed once a week. Water was supplied ad libitum.

After 2 weeks of acclimation, rats were weighed and usedThe system measures the body composition based on the principle of nuclear magnetic resonance to measure fat mass and muscle mass. Rats were then divided into 5 equivalent groups based on body weight, muscle mass and body fat.

1.3. Design of experiments

20 rats in these groups were fed 5 different diets for 16 weeks:

standard diet (6% fat, 80% carbohydrate and 14% protein in casein form; all on a dry weight basis) or

Diet (6% fat, 80% carbohydrate and 14% protein in whey form; all on a dry weight basis) containing dietary fast protein (i.e. whey protein) or

A diet containing whey protein and inulin (6% fat, 72.5% carbohydrate, 7.5% inulin and 14% protein in the form of whey; all on a dry weight basis) or

Pea protein-containing diet (6% fat, 80% carbohydrate and 14% protein in pea protein form; all on a dry weight basis) or

A diet containing pea protein and inulin (6% fat, 72.5% carbohydrate, 7.5% inulin and 14% protein in the form of pea protein; all on a dry weight basis)

Five days before the end of the 16 week period, rats were placed in metabolic cages to allow accurate and complete measurement of food intake (drinking water and food) and feces (urine and feces). Analysis of the nitrogen content in faeces and urine was then determined by the combustion method according to the Dumas method (Dumas, A. Stickstoffbestimung nach Dumas. die Praxis des org. Chemikes (N-Determination recording to Dumas), 41 th edition; Schrag: N ü rnberg, Germany, 1962).

At the end of the period, 72 animals remained alive and distributed as described in table 1.

Diet	The remaining rats (/20)
		Control	14
Whey	12
		Whey + inulin	16
Pea (Pisum sativum L.)	16
		Pea + inulin	14

Table 1-number of remaining animals at the end of the experimental protocol.

At the end of the 16-week period, the rats were fasted for 12 hours. The carbohydrate and amino acid rich solution (gavage) was forced to half of the rats in each group. All rats then received a stable isotope tracer infusion (13C-valine) to measure the protein synthesis rate 50 minutes prior to sacrifice. After sacrifice, blood, subcutaneous and perirenal adipose tissue, heart, liver, kidney, duodenum, jejunum, ileum and hindlimb were collected for different types of skeletal muscles (soleus, plantar, tibialis anterior, gastrocnemius and quadriceps).

1.4. Statistical analysis

Results are expressed as mean ± standard deviation of mean (SEM). Analysis of variance (ANOVA) was used to compare the groups (effect of diet) followed by post Fischer testing (Fischer test). Statistical analysis was performed using the software Statview and NCSS. Differences were considered significant when p < 0.05. NS means no significant difference (ANOVA p > 0.05). Two-factor ANOVA was also used to study protein type effects and fiber effects. ANOVA on repeated measures followed by a posterior Tukey-Kramer test has been used to study the temporal changes in weight, body composition and food intake.

2. Results

A significant effect on nitrogen balance was observed for the protein type or presence of dietary fiber in the diet (2-factor ANOVA-figure 1-figure 4). This effect is partly explained by the higher nitrogen balance in the fiber consuming group, especially in the presence of pea protein. The true nitrogen digestibility was highest in rats fed whey diet and lowest in rats fed inulin containing inulin (p <0.05) compared to those measured in rats fed other diets (fig. 2). The rate of digestion of proteins can be reduced, but due to the balanced amino acid composition according to need, it can be optimized by the organism's use. Furthermore, despite the decreased rate of digestion, low nitrogen excretion in urine reflects a decreased rate of oxidation of amino acids (and thus irreversible destruction). Finally, the equilibrium is more preferred (less digestion but more efficient use).

The biological value was higher in rats consuming an inulin containing diet compared to rats receiving the control and whey diet (figure 4). Also, the biological value tends to increase in rats fed pea protein.