Pea-based protein mixture and use thereof in a liquid nutritional composition suitable for enteral feeding

Abstract

This invention relates to a pea-based protein mixture and use thereof in a liquid nutritional composition, in particular suitable for tube feeding, and further relates to the liquid nutritional composition for providing long-term complete enteral nutrition to patients in need thereof. More specifically, the pea-based protein mixture and the liquid nutritional composition comprising the pea-based protein mixture comprises more than 25 weight % and up to 80 weight % of vegetable protein comprising a source of intact pea protein and a source of intact soy protein. The invention relates further to a method for long-term enteral nutrition of patients in need thereof comprising administering an effective amount of the liquid nutritional composition comprising the pea-based protein mixture, in particular comprising a defined amount of intact pea protein and a second vegetable intact protein, other than pea protein.

Claims

1. A method for the reduction of reflux, aspiration pneumonia, high gastric residual volume (GRV), vomiting, nausea, bloating, and/or delayed gastric emptying in a subject in need thereof, the method comprising administering to the subject a heat-sterilized or heat-pasteurized protein mixture comprising, based on total protein in the mixture, 25 to 80 weight % of intact vegetable proteins selected from at least two different vegetables, one of which is pea.

2. The method according to claim 1, wherein the protein mixture comprises 30 to 50 weight % of intact vegetable proteins, based on total protein weight in the mixture.

3. The method according to claim 1, wherein the protein mixture comprises 35 to 45 weight % of intact vegetable proteins, based on total protein weight in the mixture.

4. The method according to claim 1, wherein the protein mixture comprises 5 to 60 weight % of intact pea protein, based on total protein weight in the mixture.

5. The method according to claim 4, wherein the protein mixture comprises 10 to 30 weight % of intact pea protein, based on total protein weight in the mixture.

6. The method according to claim 5, wherein the protein mixture comprises 15 to 25 weight % of intact pea protein, based on total protein weight in the mixture.

7. The method according to claim 1, wherein the protein weight mixture comprises intact pea protein and intact soy protein.

8. The method according to claim 1, wherein the protein weight mixture further comprises 20 to 75 weight % dairy protein, based on total protein in the mixture.

9. The method according to claim 8, wherein the protein mixture comprises 50 to 70 weight % dairy protein, based on total protein weight in the mixture.

10. The method according to claim 9, wherein the protein mixture comprises 55 to 65 weight % dairy protein, based on total protein weight in the mixture.

11. The method according to claim 1, wherein the protein mixture comprises intact pea protein, intact soy protein, casein and whey protein.

12. The method according to claim 1, wherein the protein mixture comprises: (a) 20 to 40 weight % of casein, (b) 20 to 40 weight % of whey protein, (c) 13 to 25 weight % of intact soy protein, and (d) 13 to 25 weight % of intact pea protein, based on total protein weight in the protein mixture, wherein the sum of the proteins (a)-(d) equals 100 weight %.

13. The method according to claim 1, wherein the composition is a nutritional composition, and wherein the protein mixture comprises at least 8 en % of the total energy of the composition.

14. The method according to claim 13, wherein the composition is a nutritional composition, and wherein the protein mixture comprises at least 10 en % of the total energy of the composition.

15. The method according to claim 1, wherein the composition is a nutritional composition, having an energy content of at least 0.4 kcal/ml of composition.

16. The method according to claim 15, wherein the composition has an energy content of at least 0.7 kcal/ml of composition.

17. The method according to claim 1, wherein the administration is by tube feeding.

18. The method according to claim 1, wherein the subject is a human being.

Description

LIST OF FIGURES

(1) FIG. 1: Absolute wet weight of coagulates after 100 minutes of gastric digestion.

(2) FIG. 2: Absolute dry weight of coagulates after 100 minutes of gastric digestion.

(3) FIG. 3: Aminogram based on the PDCAAS data for Example B1. Outer line: Protein mixture of Example B1; Inner line: WHO 2007 reference.

EXAMPLES

Example A: Non-Coagulating Behavior of Pea Protein

Experimental Study Outline

(4) The coagulation properties upon gastric digestion were investigated for homogenized and heat treated protein solutions consisting of 6% (w/v) of sodium caseinate, calcium caseinate, whey, intact pea, and intact soy.

(5) Gastric Digestion

(6) Stomach digestion was mimicked over 100 minutes in a computer controlled substrate pump setup (Multifermentor fed-batch; DASGIP AG, Juelich, Germany) at 37 C. upon continuous stirring.

(7) For each experiment, 150 ml of protein solution were used as the starting volume. Per experiment, a total of 45 ml of artificial stomach juice (50 mM NaCl, 15 mM KCl, 1 mM CaCl.sub.2.H.sub.2O, 15 mM NaHCO.sub.3, 0.014% (w/v) pepsin (porcine stomach, sigma p7012), 0.019% (w/v) lipase (Rhizopus oryzae, DF 15K Amano Pharmaceutical Co, Ltd Nagoya); pH 4.0) was added. The stomach juice was added in two steps with different flow rates. In the first two minutes, a flow rate of 225 ml/h was used. For the rest of the experiment the flow rate was 23 ml/h. In addition, in the first 60 minutes of the experiment a total of 30 ml of artificial saliva (0.1 M NaCl, 30 mM KCl, 2 mM CaCl.sub.2.2H.sub.2O, 15 mM NaHCO.sub.3, 0.065% (w/v) -amylase (Sigma A 6211); pH 6.3) was added continuously to the solution.

(8) The pH was decreased over 100 minutes from a pH of 6.6 at start to a final pH of 2.0 (pH at start=6.6, pH at 8 minutes=5.0, at 15 minutes=4.0, at 42 minutes=3.0, at 100 minutes=2.0) by the addition of 1 M HCl upon continuous mixing. If necessary, acidification was automatically corrected by the addition of an alkaline solution (1 M NaHCO.sub.3, 3 M NaOH).

(9) Determination of Coagulate

(10) After gastric digestion, the samples were poured over metal sieves to yield fractions with particle sizes of a) bigger than 2 mm, b) below 2 mm and above 1 mm, c) below 1 mm and above 0.25 mm and d) below the limit of 0.25 mm. Fractions a) to c) constitute what is here referred to as coagulate. The wet and dry weight of these three fractions was determined separately. In short, after determining the wet weight the dry weight was determined according to Monjonnier. Samples were gently heated to evaporate the water and subsequently placed in a vacuum oven. The residue constitutes the absolute dry weight of the sample.

(11) All experiments were performed in triplicate.

(12) Results

(13) Results are given as meanSEM. Sodium caseinate yielded 43.50.9 g of total wet coagulate (FIG. 1) and 6.40.6 g of total dry coagulate (FIG. 2). Calcium caseinate yielded 52.87.5 g of total wet coagulate (FIG. 1) and 6.20.7 g of total dry coagulate (FIG. 2). Whey, soy, and pea did not produce any measurable wet or dry coagulate (FIGS. 1 and 2).

Example B

(14) The following protein compositions can suitably be used as an enteral composition according to the invention, respectively as adult tube feed, as paediatric tube feed and as an adult oral nutritional supplement (Table 3).

(15) TABLE-US-00003 TABLE 3 Ex. B3 Ex. B1 Ex. B2 Adult Oral Adult tube Paediatric tube nutritional Component feed feed supplement Energy value (kcal/100 ml) 100 100 240 Protein (g/100 ml) 4 2.5 9.6 (En %) 16 10 16 Pea 0.8 g/100 ml 0.50 g/100 ml 1.92 g/100 ml protein 1.4 g/100 ml 0.87 g/100 ml 3.36 g/100 ml Whey 1.0 g/100 ml 0.63 g/100 ml 2.40 g/100 ml protein 0.8 g/100 ml 0.50 g/100 ml 1.92 g/100 ml Casein Soy protein Carbohydrates 12.3 g/100 ml 12.5 g/100 ml 29.7 g/100 ml (49 En %) (50 En %) (49 En %) Fat 3.9 g/100 ml 4.4 g/100 ml 9.3 g/100 ml (35 En %) (40 En %) (35 En %) Fibre 1.5 g/100 ml none none Viscosity 18 mPa .Math. s 12 mPa .Math. s 25 mPa .Math. s Density 1.06 kg/l The composition is supplemented with appropriate amounts of minerals, trace elements and vitamins, carotenoids and choline to provide a complete nutritional composition

(16) Quality Determination

(17) The protein mixture used Example B1 (adult tube feed) and its quality was characterised by determining the Protein Digestibility Corrected Amino Acid Score (PDCAAS) using the essential amino acid content of the different individual protein sources, their digestibility and the WHO 2007 amino acid recommendations as reference. The PDCAAS of this protein mixture is the lowest PDCAAS value of the individual amino acids, which is 1.2 (Table 4).

(18) TABLE-US-00004 TABLE 4 WHO 2007 reference AA Casein Soy Whey Pea pattern PDCAAS Cysteine 0.40 1.20 2.60 1.00 0.6 2.4 Histidine 3.10 2.50 1.55 2.30 1.5 1.5 Isoleucine 5.80 5.10 7.20 4.10 3.0 1.9 Leucine 10.10 8.40 11.80 7.60 5.9 1.6 Lysine 8.40 5.60 10.70 6.70 4.5 1.8 Methionine 2.90 1.40 2.40 0.90 1.6 1.2 Threonine 4.60 3.90 8.60 3.50 2.3 2.4 Tryptophan 1.40 1.30 1.65 0.90 0.6 2.2 Valine 7.50 5.10 6.80 4.50 3.9 1.6 Met + Cys 3.30 2.60 5.00 1.90 2.2 1.5 Phe + Tyr 11.20 9.40 7.15 8.30 3.0 2.9 Digestibility 98 98 98 98 (%)

(19) Using these PDCAAS data, the concomitant aminogram is shown in FIG. 3.

(20) It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the spirit and scope of the invention and without diminishing its advantages. It is therefore intended that such changes and modifications are covered by the appended claims.