PROTEIN-DENSE NUTRITIONAL COMPOSITIONS FOR USE IN TREATING AND/OR PREVENTING A CONDITION LINKED TO LOSS OF MUSCLE MASS AND/OR STRENGTH

Abstract

The invention relates to the field of protein-dense liquid nutritional compositions for use in the treatment and/or prevention of a condition linked to loss of muscle mass and/or strength. Provided is a heat-treated liquid high-protein composition comprising at least 10 g of protein per 100 ml of the composition, wherein at least 40 wt. % of the protein is micellar casein and at least 10 wt. % of the protein is hydrolysed whey protein having a degree of hydrolysation of at least 5%, and wherein the weight ratio of micellar casein to hydrolysed whey protein is in the range of 40:60 to 90:10, for use in any one or more of the following: a) preventing or reducing coagulation in the upper gastro-intestinal tract; b) increasing the rate of gastric emptying; c) enhancing protein digestion; d) increasing the blood serum concentration of free essential amino acids, preferably leucine, in a subject.

Claims

1. A method of (a) preventing or reducing coagulation in the upper gastro-intestinal tract; (b) increasing the rate of gastric emptying; (c) enhancing protein digestion; (d) increasing the blood serum concentration of free essential amino acids in a subject in a disease state, recovering from a disease state, and/or malnourished, the method comprising administering to the subject a heat-treated liquid high-protein composition comprising at least 10 g of protein per 100 ml of the composition, comprising: (i) at least 40 wt. % of the protein as micellar casein; and (ii) at least 10 wt. % of the protein as hydrolysed whey protein having a degree of hydrolysation of at least 5%, and wherein the weight ratio of micellar casein to hydrolysed whey protein is in the range of 40:60 to 90:10.

2. The method according to claim 1, wherein the subject suffers from a decline of lean muscle mass, muscle wasting, muscle decline, bone decline, sarcopenia, osteoporosis and/or osteosarcopenia.

3. The method according to claim 1, wherein micellar casein and hydrolysed whey protein are present in the composition in a combined amount of at least 70 wt % of the total protein.

4. The method according to claim 1, wherein the protein provides 20% to 95% of the total energy content of the composition.

5. The method according to claim 4, wherein the protein provides 50% to 80% of the total energy content of the composition.

6. The method according to claim 1, wherein the composition comprises at least 12 g protein per 100 ml of the composition.

7. The method according to claim 1, wherein the composition has a unit serving size comprising at least 12 g of protein.

8. The method according to claim 1, wherein the composition has a unit serving size of up to 125 ml.

9. The method according to claim 1, wherein at least 50 wt. % of the protein is micellar casein and/or at least 15 wt. % of the protein is hydrolysed whey protein.

10. The method according to claim 1, wherein the weight ratio of micellar casein to hydrolysed whey protein is in the range of 60:40 to 90:10.

11. The method according to claim 1, wherein the hydrolysed whey protein has a degree of hydrolysation in the range of 5 to 25%.

12. The method according to claim 1, wherein the viscosity of the composition is 150 mPa.Math.s or lower, at 20 C. and at a shear rate of 100 s.sup.1.

13. The method according to claim 1, wherein the composition has an energy density of 1.5 kcal/ml or higher.

14. The method according to claim 1, wherein the composition further comprises vitamins and/or minerals.

15. The method according to claim 13, wherein the vitamins are selected from the group consisting of vitamin D, vitamin B1, vitamin B2, vitamin B12 and vitamin K.

16. The method according to claim 1, wherein the minerals are selected from the group consisting of calcium, magnesium, phosphorus and selenium.

17. The method according to claim 1, wherein the composition further comprises a leucine metabolite.

18. The method according to claim 16, wherein the leucine metabolite is beta-hydroxy-beta-methylbutyrate (HMB).

19. The method according to claim 1, wherein the composition increases the blood serum concentration of essential amino acids to overcome anabolic resistance in a subject, preferably an elderly subject.

20. The method according to claim 1, wherein the composition increases the blood serum concentration of leucine in a subject to higher than 250 micromol/L, preferably higher than 300 micromol/L within about 60 minutes after administration.

21. A method of treatment and/or prevention of a condition linked to a loss of muscle mass and/or strength in a subject in a disease state, recovering from a disease state, and/or malnourished, the method comprising administering to the subject a heat-treated liquid high-protein composition comprising at least 10 g of protein per 100 ml of the composition, comprising: (i) at least 40 wt. % of the protein as micellar casein; and (ii) at least 10 wt. % of the protein as hydrolysed whey protein having a degree of hydrolysation of at least 5%, and wherein the weight ratio of micellar casein to hydrolysed whey protein is in the range of 40:60 to 90:10.

22. A heat-treated liquid nutritional composition in a unit serving size of up to 100 ml, having at least 40 wt. % of protein being micellar casein and at least 10 wt. % of being hydrolysed whey protein having a degree of hydrolysation of at least 5%, wherein the ratio of micellar casein to hydrolysed whey protein is in the range of 40:60 to 90:10, and wherein the composition comprises at least 15 g of protein.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0117] FIG. 1. pH profile of the gastric simulation model over time.

[0118] FIG. 2. Percentage of protein in liquid phase over time in the stomach phase of digestion. For details see Example 1.

[0119] FIG. 3. Percentage of protein in liquid phase over time in the stomach phase of digestion. For details see Example 2.

EXPERIMENTAL SECTION

Materials and Methods

[0120] Protein digestion data were obtained using an established in vitro digestion stomach model. Gastric emptying is the rate limiting step in digestion. Given that the transit time of liquids through the stomach is much faster than that of (semi)solids, the amount of protein in thefast emptyingliquid fraction (or liquid phase) is key for a fast digestion.

Protein Sources Used:

[0121] Refit MCI 88 is a source of micellar casein, comprising 88 wt. % of protein, based on total dry matter, and about 90-95 wt. % of micellar casein protein and about 5-10 wt. % whey protein, based on protein dry matter.

[0122] Hyvital Whey 8016 is a mildly hydrolysed whey protein from fresh milk whey, having a protein content of about 80 wt. % based on total dry matter. Hyvital Whey 8016 has a degree of hydrolysis (DH) in the range of 7-10%. Hyvital Whey EtD 120 is a mildly hydrolyzed whey protein, which typically contains about 77% protein. The product is derived from fresh milk or alternatively from acid whey. Hyvital Whey EtD120 has a DH of about 8%.

[0123] Excellion Sodium Caseinate (NaCas) is a casein based protein obtained from fresh milk by acid precipitation. The product contains about 90% protein.

[0124] NutriWhey 800F (WPC80) is a whey protein concentrate with about 80% protein, obtained by ultrafiltration of acid whey.

[0125] In order to determine the amount of protein in the liquid phase, first, a test composition (depending on protein concentration of test product e.g. volume of 100 or 350 ml) is heated in the fermenter to 37 C. under continuous stirring at 50 rpm and a reference sample is taken (x.0). Subsequently, a simulated gastric fluid (350 mL) is added to the product in the fermenter, as described in Minekus Food Funct., 2014, 5:1113, consisting of: [0126] 243.2 mL of SGF electrolyte stock solution [0127] 60.8 mL porcine pepsin stock solution of 25,000 U/mL made up in SGF electrolyte stock solution (pepsin from porcine gastric mucosa, 3,200-4,500 U/mg protein, Sigma); [0128] 190 L of 0.3 M CaCl2; [0129] 1900 L of 1 M HCl to reach pH 3.0; [0130] 73.9 mL of water.

[0131] A first sample (x.1) is immediately taken as a reference and subsequently a pH is being profiled (a declining curve over time is established with HCl and NaOH, slope for all the samples similar as shown in FIG. 1).

[0132] The incubation is maintained for e.g. 1 to 3 hours at 37 C.

[0133] During digestion, samples (1*40 ml per sampling point) are taken for analysis during the test series. Pictures of the fermenter are taken at the same time the 40 ml samples are taken and samples are filtered on a gauze (mesh size 1 to 2 mm) immediately. Observations are written down in a logbook.

[0134] The sample filtrate is immediately cooled on ice to stop enzyme activity and subsequently divided for different analyses: [0135] 1.0 ml for protein analysis with LC-MS: flashfrozen immediately after filtration and stored at 20 C. till analysis. [0136] 2*12 ml for further analyses: immediately flashfrozen and stored at 20 C. till analysis. [0137] Rest sample for protein analysis

Example 1

[0138] In this Example, the digestibility was assessed for compositions comprising a blend of micellar casein and a hydrolysed whey protein (test composition A), a blend of micellar casein and sodium caseinate (test composition B) and for a composition comprising native whey (test composition C).

[0139] Protein analysis (Table 1) of the test compositions revealed the following:

[0140] A: 10% MCI with whey hydrolysate: 10 g protein per 100 ml in a 67:33 weight ratio.

[0141] B: 10% MCI with sodium caseinate: 10 g protein per 100 ml in a 67:33 weight ratio.

[0142] C: 10% Whey protein: 10 g protein per 100 ml.

TABLE-US-00001 TABLE 1 Results of the protein analyses (Kjeldahl) A B C Time (min) MCI88:HWP8016 MCI88:NaCas WPC80 0 10.09 10.39 10.1 0 2.71 2.69 2.66 15 2.69 1.17 2.66 30 2.65 1.24 2.66 45 2.60 1.48 2.64 60 2.55 1.67 2.62 90 2.50 1.97 2.58 120 2.46 2.45 2.50

[0143] As is demonstrated in Table 1 and FIG. 2, a blend of MCI and hydrolysed whey protein (Composition A, MCI:HWP 8016) stays in a liquid phase under pH stomach conditions in adults, which is in marked contrast to the lumping observed for the MCI:NaCas blend (Composition B). Since protein in the liquid phase is likely to leave the stomach faster, digestion of the MCI:HWP protein blend is faster than that of the MCI:NaCas blend, which gels or coagulates in the stomach and therefore results in delayed gastric emptying and digestion.

[0144] Even more surprisingly, the gastric emptying of a MCI:HWP composition of the invention was comparable to that of whey protein, as shown by the WPC80 reference sample in FIG. 2 (Composition C).

Example 2

[0145] In this experiment, the digestibility was assessed for compositions comprising a blend of micellar casein and different hydrolysed whey protein (test compositions E and F). Also, the relevance of the whey being hydrolyzed in these test products was investigated with reference composition G comprising native whey. In reference composition H, the weight ratio of micellar casein to hydrolysed whey protein is 95:5, and thus outside the claimed range of 90:10.

[0146] The following test compositions were prepared:

[0147] E: MCI88:HWP EtD120: 10 g protein per 100 ml in a 67:33 weight ratio

[0148] F: MCI88:HWP 8016: 10 g protein per 100 ml in a 67:33 weight ratio (same proteins and ratio as in test product B in experiment 1) G: MCI88:WPC80: 10 g protein per 100 ml in a weight ratio of 80:20 (as in bovine milk)

[0149] H: MCI88:8016: 10 g protein per 100 ml in a weight ratio of about 95:5

[0150] The results in Table 2 and FIG. 3 demonstrate that, in agreement with the data shown above in Table 1, the protein in the test compositions with MCI:HWP 8016 (F) and MCI:HWP EtD120 (E) stays in a liquid phase under pH stomach conditions in adults (as shown in experiment 1). In contrast, protein in a composition comprising MCI88: WPC80 in a 80:20 weight ratio (G), i.e. lacking hydrolysed whey protein and similar to the ratio in bovine milk, was largely depleted (60-80%) from the liquid phase. This is indicative of a delayed gastric emptying. The same holds true for a blend comprising 95 wt % MCI88 and 5 wt % hydrolysed whey protein (H).

TABLE-US-00002 TABLE 2 Results of protein analysis (Kjeldahl) Time E F G H (min) MCI88:HWPEtD120 MCI88:HWP8016 MCI88:WPC80 MCI88:HWP8016 0 10.3 10.0 10.13 10.1 0 2.70 2.60 0.49 0.57 15 2.66 2.56 0.86 0.50 30 2.64 2.58 0.73 0.59 45 2.63 2.58 0.84 0.69 60 2.60 2.52 0.97 0.80 75 2.58 2.49 1.10 0.89 90 2.56 2.50 1.22 0.99