KR20230112745A - gel nutritional composition - Google Patents

Abstract

A gel nutritional composition comprising lipids, proteins, carbohydrates, vitamins and minerals and having the following constitution; The energy value of the composition is 0.8 kcal/g or more and 1.2 kcal/g or less; 1.7 g or more of whole milk protein and 0.25 g or more of casein per 100 g of the composition as protein; The total amount of magnesium derived from whole milk protein and casein is 1.3 mg or more per 900 kcal of the composition, and the total amount of calcium derived from whole milk protein and casein is 34.9 mg or more per 900 kcal of the composition; contains at least 220 mg of magnesium and at least 500 mg of calcium per 900 kcal of the composition; per 900 kcal of the composition, as a mineral, at least one selected from 30 μg or more of selenium, 10 μg or more of chromium, 30 μg or more of molybdenum, and 130 μg or more of iodine; containing 0.15% by weight or more and 0.40% by weight or less of agar, containing 0.125% by weight or more and 0.40% by weight or less of alginic acid or a salt thereof, and having a viscosity of 3,000 mPa·s or more and 17,000 mPa·s or less; A total of 2.0 g or more and 5.7 g or less of a chelating agent selected from citric acid or a salt thereof, phosphoric acid or a salt thereof, and EDTA or a salt thereof per 900 kcal of the composition, and also contains 1.1 g or more and less than 3.7 g of phosphoric acid or a salt thereof per 900 kcal of the composition.

Description

gel nutritional composition

The present invention relates to a nutritional gel composition, and more particularly, to a nutritional gel composition suitable for ingestion of essential vitamins and minerals.

BACKGROUND OF THE INVENTION Patients before and after surgery, elderly people who have difficulty in eating normal meals, and care recipients need sufficient nutrition to live a healthy life. Nutritional management is performed by administering a nutritional composition, and the nutritional composition is adjusted to include nutritional components such as proteins, lipids, carbohydrates, vitamins, and minerals in a well-balanced manner (Patent Documents 1 to 4).

Long-term administration of the enteral nutritional composition causes great pain to the recipient, and the elderly and care recipients often do not have a large stomach capacity, so the energy value is high. Moreover, for example, as shown in Non-Patent Document 1, if it is a nutritional composition that sufficiently contains the standard amount and recommended amount of minerals or vitamins required for a day, the dosage can be suppressed, the burden on the recipient is reduced, and efficient nutritional supplementation is possible. Adjustment of the energy value (calorie) of the nutritional composition is generally possible by adjusting the content of lipids, proteins, and carbohydrates.

In addition, if it is an enteral nutrition composition in the form of a gel, it is expected to exhibit the physiological function of retention and discharge originally possessed by the stomach. As a result, it is possible to administer in a short time compared to the liquid nutritional composition, and it is possible to secure time for rehab with less movement or action restrictions, thereby contributing to early healing and daily living (ADL) improvement. Moreover, the effect which can prevent aspiration pneumonia and diarrhea seen with a liquid nutritional composition is also suggested.

WO2006/033349 Japanese Patent No. 4047363 WO2013/085059 WO2014/115768

Japanese Dietary Intake Standards (2020 Edition), December 2019 「Japanese Dietary Intake Standards」 formulation review meeting

For example, even in a patient for energy management at a low dose of about 900 kcal per day, it is necessary not to lack vitamin and mineral intake per day. As described above, when about 900 kcal is ingested by a nutritional composition, the gel-like nutritional composition that can consume the standard amount and recommended daily intake of vitamins and minerals as described in Non-Patent Document 1 has various advantages, but no such nutritional composition has been provided so far.

For example, the comprehensive enteral nutritional composition described in Patent Document 1 is a composition with a high content of vitamin B1 and vitamin B2, and the nutritional composition described in Patent Document 3 contains two or more types of minerals selected from sodium, potassium, iron, calcium and magnesium, but they are not gel-like and are not a composition capable of ingesting a daily intake of vitamins and minerals.

The gel-like enteral nutrient described in Patent Literature 2 is not a nutrient that can be ingested in a standard amount or recommended amount of daily intake of vitamins, minerals, etc. The liquid nutrition composition described in Patent Literature 4 is not gel-like.

Under the above background, the present invention is a nutritional composition capable of ingesting daily energy intake by means of a nutritional composition, and it is possible to formulate a standard amount and a recommended amount of daily intake of vitamins and minerals. It is also an object to provide a gel-like nutritional composition that is easy to ingest and stable.

In order to solve the above problems, the present inventors first increased the vitamin and mineral concentrations of the semi-solid enteral nutritional composition as described in Patent Document 2, and found that local gelation occurred and a non-uniform gel was obtained. On the other hand, as described in Patent Document 4, when an attempt was made to gel a high-concentration liquid nutrient composition with a large amount of vitamins and minerals, it was found that stable gelation was hindered and a non-uniform gel was obtained.

The present inventors repeated further intensive examinations and first used specific raw materials such as whole milk protein and casein as protein raw materials. Furthermore, since the ion concentration, including calcium ions, is high in nutritional compositions with high vitamin and mineral formulations, when the amount of chelating agent is increased, it is found that the stability of the nutritional composition is unexpectedly lowered, and the appropriate blending value of the chelating agent is found. The present invention was completed.

That is, the present invention relates to the following.

[One]

A gel nutritional composition comprising lipids, proteins, carbohydrates, vitamins and minerals, and having the following configurations.

1) the energy value of the composition is 0.8 kcal/g or more and 1.2 kcal/g or less;

2) Contains 1.7 g or more of whole milk protein and 0.25 g or more of casein per 100 g of the composition as protein;

3) the total amount of magnesium derived from the whole milk protein and casein is 1.3 mg or more per 900 kcal of the composition, and the total amount of calcium derived from the whole milk protein and casein is 34.9 mg or more per 900 kcal of the composition;

4) contains at least 220 mg of magnesium and at least 500 mg of calcium per 900 kcal of the composition;

5) per 900 kcal of the composition, as a mineral, at least one selected from 30 μg or more of selenium, 10 μg or more of chromium, 30 μg or more of molybdenum, and 130 μg or more of iodine;

6) contains 0.15% by weight or more and 0.40% by weight or less of agar, contains 0.125% by weight or more and 0.40% by weight or less of alginic acid or a salt thereof, and has a viscosity of 3,000 mPa·s or more and 17,000 mPa·s or less;

7) A total of 2.0 g or more and 5.7 g or less of a chelating agent selected from citric acid or a salt thereof, phosphoric acid or a salt thereof, and EDTA or a salt thereof per 900 kcal of the composition, and 1.1 g or more and less than 3.7 g of the phosphoric acid or salt thereof per 900 kcal of the composition.

[2]

The gel nutritional composition according to [1], wherein the ratio of the casein to the whole milk protein is 1:1.1 to 1:13 by weight of the protein contained.

[3]

The gel nutritional composition according to [1] or [2], wherein the whole milk protein is a milk protein concentrate.

[4]

The gel nutritional composition according to any one of [1] to [3], which does not contain animal protein degradation products and vegetable protein degradation products.

[5]

The lipid content in the composition is 20% or more and 30% or less in terms of energy ratio,

The protein content in the composition is 13% or more and 30% or less in terms of energy ratio,

The gel nutritional composition according to any one of [1] to [4], wherein the carbohydrate content in the composition is 50% or more and 65% or less in terms of energy ratio.

[6]

The nutritional gel composition according to any one of [1] to [5], containing 310 mg or more of magnesium and 650 mg or more of calcium per 900 kcal of the composition.

[7]

The gel nutritional composition according to any one of [1] to [6], containing at least the following vitamins and minerals per 900 kcal of the composition.

[Table 1]

[8]

The gel nutritional composition according to any one of [1] to [7], wherein the pH is higher than 5.5 and is lower than or equal to pH 7.0, and the ratio of the total amount of magnesium and calcium per 900 kcal of the composition: the amount of the chelating agent is 1:4.5 or less.

According to the present invention, as a nutritional composition capable of ingesting daily energy intake, it is possible to formulate a standard amount and recommended amount of daily intake of vitamins and minerals, etc., and since it is in a gel form, it is easy to ingest and can prevent gastroesophageal reflux, which can cause aspiration pneumonia, and can provide a stable gel-like nutritional composition.

Hereinafter, the mode for carrying out the present invention (hereinafter, referred to as "the present embodiment") will be described in detail. On the other hand, the present invention is not limited to the present embodiment below, and can be implemented with various modifications within the scope of the gist.

The gel nutritional composition of the present embodiment contains lipids, proteins, carbohydrates, vitamins and minerals,

1) The energy value of the composition is 0.8 kcal / g or more and 1.2 kcal / g or less,

2) Contains 1.7 g or more of whole milk protein and 0.25 g or more of casein per 100 g of the composition as protein,

3) The total amount of magnesium derived from the whole milk protein and casein is 1.3 mg or more per 900 kcal of the composition, and the total amount of calcium derived from the whole milk protein and casein is 34.9 mg or more per 900 kcal of the composition,

4) Per 900 kcal of the composition, containing 220 mg or more of magnesium and 500 mg or more of calcium,

5) As a mineral per 900 kcal of the composition, at least one selected from 30 μg or more of selenium, 10 μg or more of chromium, 30 μg or more of molybdenum, and 130 μg or more of iodine,

6) Contains 0.15% by weight or more and 0.40% by weight or less of agar, contains 0.125% by weight or more and 0.40% by weight or less of alginic acid or a salt thereof, and has a viscosity of 3,000 mPa s or more and 17,000 mPa s or less,

7) A total of 2.0 g or more and 5.7 g or less of a chelating agent selected from citric acid or a salt thereof, phosphoric acid or a salt thereof, and EDTA or a salt thereof per 900 kcal of the composition, and 1.1 g or more and less than 3.7 g of the phosphoric acid or salt thereof per 900 kcal of the composition.

Examples of the whole milk protein include whole milk itself, whole milk concentrate, protein prepared from whole milk, skim milk, skim milk concentrate, milk protein concentrate (also referred to as MPC), skim milk powder from which lactose has been removed, synthetic milk protein, etc. Among them, it is preferable to use a milk protein concentrate (e.g., about 80 to 82% protein content).

Examples of casein (for example, about 90 to 92% in protein content) include acid casein such as lactate casein, casein hydrochloride, casein sulfate, or mixtures thereof separated from milk according to a commercial method; The caseinate etc. which consist of caseinate salts, such as sodium caseinate and calcium caseinate, are mentioned.

The gel nutritional composition of the present embodiment contains, as protein, 1.7 g or more, preferably 2.0 g or more and 7.5 g or less, more preferably 2.5 g or more and 6.5 g or less, still more preferably 3.0 g or more and 5.5 g or less, per 100 g of the composition. Further, the gel nutritional composition of the present embodiment contains 0.25 g or more, preferably 0.25 g or more and 3.6 g or less, more preferably 0.54 or more and 2.0 g or less, still more preferably 0.88 g or more and 1.9 g or less of casein as protein per 100 g of the composition.

In one embodiment, in the gel nutritional composition of the present embodiment, the ratio of whole milk protein and casein in protein (in terms of protein amount) in total is 75% by weight or more, preferably 82% by weight or more, more preferably 92% by weight or more, still more preferably 95% by weight or more, particularly preferably 98% by weight or more, and most preferably 100% by weight.

In one aspect, the gel nutritional composition of the present embodiment does not contain either animal protein degradation product or vegetable protein degradation product, and in one embodiment, the gel nutritional composition of the present embodiment contains neither animal protein degradation product nor vegetable protein degradation product. Animal protein degradation products and vegetable protein degradation products are proteins decomposed by acids or enzymes, and are used in nutritional compositions because of their good dispersibility.

The gel nutritional composition of this embodiment contains whole milk protein more than casein among proteins. Without being bound by theory, with this configuration, calcium can be incorporated in a form bound to protein, and high concentrations of magnesium and calcium can be incorporated by binding free magnesium and calcium with casein.

The ratio of the casein to the whole milk protein is preferably 1:1.1 to 1:13, more preferably 1:1.1 to 1:4.3, still more preferably 1:1.1 to 1:2.9, and particularly preferably 1:2.5 to 1:2.8, in terms of the weight ratio of the protein contained. If the whole milk protein is more than casein, magnesium and calcium can be contained as whole milk protein, so even if a large amount of minerals are contained, it is stable, which is preferable. Moreover, when whole milk protein is 13 times by weight or less of casein, it is preferable also from a viewpoint that stabilization of the gel state of a nutritional composition becomes easier. On the other hand, in the calculation of the ratio, about the casein contained in the whole milk protein, it shall not be calculated as casein.

In one aspect, in the gel nutritional composition of the present embodiment, the whey (other than whey contained in whole milk protein) in the protein is less than 2 g / 100 g, preferably 1 g / 100 g or less, more preferably 0.7 g / 100 g or less, and still more preferably does not contain whey.

It is preferable that it is 13 to 30% in energy ratio, and, as for content of the protein in the gelled nutrition composition of this embodiment, it is more preferable that it is 13 to 19%. If the protein content exceeds 30% in terms of energy ratio, the nutritional balance of the PFC ratio of the dietary intake standards of the Ministry of Health, Labor and Welfare may deteriorate, and if it is less than 13%, the protein intake may be insufficient. On the other hand, the energy ratio shall be calculated as 4 kcal/g.

The lipid contained in the gel nutritional composition of the present embodiment is not particularly limited as long as it can be generally administered orally or through the tube. For example, vegetable oils such as soybean oil, perilla oil, perilla oil, sunflower oil, supflower oil, crude oil, canola oil, palm oil, corn oil, corn oil, coco oil, olive oil, and rice bran oil; animal fats and oils such as fish oil and beef tallow; MCTs (triglycerides, medium chain length fatty acids); highly unsaturated fatty acids such as eicosapentaenoic acid, docosahexaenoic acid, linolenic acid, and linoleic acid; etc. can be mentioned. Lipids may be used individually by 1 type, or may be used in mixture of 2 or more types. From the viewpoint of sufficient essential fatty acids, it is preferable to use a plurality of lipids in combination.

It is preferable that it is 30 % or less in energy ratio, and, as for content of the lipid in the gelled nutrition composition of this embodiment, it is more preferable that it is 20 % - 30 %. When the lipid content is 30% or less in terms of energy ratio, the nutritional balance of the PFC ratio is good and preferable. On the other hand, the energy ratio shall be calculated as 9 kcal/g. When the lipid content is 20% or more in terms of energy ratio, essential fatty acids can be replenished as lipids, which is preferable.

Carbohydrates contained in the gel-like nutritional composition of the present embodiment are not particularly limited as long as they can be generally administered orally or through the tube. For example, powdered sugar, starch, dextrin, maltodextrin, lactose, sucrose, glucose, fructose, maltose and the like. A carbohydrate may be used individually by 1 type, and may mix and use 2 or more types. In particular, powdered candy and/or maltodextrin are preferable from the viewpoint of suppressing sweetness and being economical.

The content of the carbohydrate in the gel nutritional composition of the present embodiment is determined from the blending amount of protein and lipid, and the blending amount varies appropriately, but it is preferably 50% to 65% in terms of energy ratio. When the content of carbohydrates is 50% to 65% as an energy ratio, it is preferable because the nutritional balance of the PFC ratio is improved. On the other hand, the energy ratio assumes that the energy of carbohydrates is calculated as 4 kcal/g.

The gel nutritional composition of this embodiment contains vitamins and minerals. Examples of vitamins and minerals include those described in Dietary Reference Intakes for Japanese People (Non-Patent Document 1). Vitamins include, for example, vitamin A, vitamin D, vitamin E, vitamin K, vitamin B1, vitamin B2, niacin, vitamin B6, vitamin B12, folic acid, pantothenic acid, biotin, and vitamin C. At least one of these vitamins may be contained, and it is preferable to contain all of them. Moreover, as a mineral, calcium, magnesium, phosphorus, iron, zinc, copper, manganese, iodine, selenium, chromium, molybdenum, etc. are mentioned, for example. The nutritional gel composition of the present embodiment contains at least magnesium, calcium, selenium, chromium, molybdenum and iodine, and preferably further contains at least one of phosphorus, iron, zinc, copper and manganese, more preferably all of them. In one aspect, the gel nutritional composition of this embodiment contains various vitamins and minerals, so that vitamins and minerals necessary for a day can be ingested only from the nutritional composition.

The nutritional gel composition of the present embodiment may contain 220 mg or more, preferably 290 mg or more, more preferably 310 mg or more, still more preferably 370 mg or more, which is the recommended amount for women, per 900 kcal of the composition. This magnesium may be contained in other components, such as whole milk protein and casein, for example. Including 310mg/900kcal or more of magnesium is preferable because it satisfies the estimated average required amount of the dietary intake standard for those aged 18 years or older, and including 370mg/900kcal or more is more preferable because it can satisfy the recommended amount of the dietary intake standard for all ages. The upper limit of magnesium is not particularly limited, but may be equal to the upper limit of the amount of calcium described below, and in one aspect, may be, for example, about half of the amount of calcium.

The nutritional gel composition of the present embodiment may contain 500 mg or more, preferably 650 mg or more, more preferably 800 mg or more, which is the lowest value (female aged 75 years or older) that satisfies the estimated average required amount of calcium per 900 kcal of the composition. For example, per 900 kcal of the composition, calcium can be blended in the range of 650 to 2500 mg, preferably 700 to 2500 mg, more preferably 750 to 1333 mg, still more preferably 800 to 1250 mg, for example 815 to 1250 mg. This calcium may be contained in other components, such as whole milk protein and casein, for example. When calcium is blended at 650 mg/900 kcal or more, it is preferable because it satisfies the estimated average required amount of the dietary intake standard for those aged 18 years or older, and when it is formulated to be 800 mg/900 kcal or higher, it is more preferable because it can satisfy the recommended amount for the dietary intake standard for those aged 18 years or older. In particular, when calcium is blended in the range of 1250mg/900kcal or less, for example, even when 1500kcal of energy is consumed per day, it is preferable because the upper content limit of 2500mg is not exceeded. intake is also possible. In one aspect, especially when calcium is blended in the range of 1250 mg/900 kcal or less, for example, even when 1800 kcal of energy is consumed per day, it is preferable because the upper content limit of 2500 mg is not exceeded. is present, and intake from other foods is also possible.

In the gel nutritional composition of the present embodiment, from the viewpoint of stability, the total amount of magnesium derived from the whole milk protein and casein per 900 kcal of the composition is 1.3 mg or more, and the upper limit is preferably 370 mg or less, and further preferably 13 mg or more, more preferably 20 mg or more, and still more preferably 30 mg or more. Similarly, the total amount of calcium derived from the whole milk protein and casein per 900 kcal of the composition is 34.9 mg or more, and the upper limit is preferably 880 mg or less, further preferably 88 mg or more, more preferably 200 mg or more, still more preferably 400 mg or more, still more preferably 640 mg or more, and particularly preferably 700 mg or more.

The gel nutritional composition of this embodiment contains a mineral, and preferably contains at least one mineral selected from selenium, chromium, molybdenum, and iodine, and more preferably contains all of these minerals. In particular, as a mineral per 900 kcal of the composition, it is preferable to include at least one selected from 30 μg or more of selenium, 10 μg or more of chromium, 30 μg or more of molybdenum, and 130 μg or more of iodine, and more preferably all of them are included.

The content of vitamins and minerals other than the above can be preferably set so as to satisfy the recommended intake amount or reference amount described in the dietary intake standards. The following is the daily dietary intake standard of each vitamin and mineral calculated from Non-Patent Document 1, and in one aspect, it is preferable to include an amount that satisfies at least one of the following, preferably at least 5, more preferably at least 10, still more preferably at least 15, particularly preferably all of the following per 900 kcal of the composition. Furthermore, vitamins and minerals not described below may be included.

[Table 2]

For example, in the case of an adult of 18 years of age or older, the recommended amount and standard amount of intake of each component at the time of daily intake are set as follows (see Non-Patent Document 1).

Vitamin A (retinol palmitate) 900-2700μg RE (retinol equivalent), vitamin D (cholecalciferol) 8.5-100μg, vitamin E (tocopheryl acetate) 7.0-650mg (α-tocopherol equivalent), vitamin K 150μg or more, vitamin B_One(Thiamin chloride hydrochloride) 1.4 mg or more (1101 μg or more in terms of thiamine), vitamin B₂(riboflavin) 1.6 mg or more, niacin (nicotinic acid amide) 15-250 mg, vitamin B₆(Pyridoxine) 1.4~40mg, Vitamin B₁₂(Cyanocobalamin) 2.4μg or more, folic acid 240-900μg, pantothenic acid 6mg or more, biotin 50μg or more, vitamin C (ascorbic acid) 100mg or more, phosphorus 1000-3000mg, iron 11-40mg, zinc 11-30mg, manganese 4.0-11mg, copper 0.9-7mg, iodine 13 0~3000μg, selenium 30~350μg, chromium 10~500μg, molybdenum 30~500μg.

In view of this, when blending vitamins and minerals in the gel nutritional composition of the present embodiment, it is preferable to blend so as to satisfy the following per 900 kcal of the composition, keeping in mind that 1500 kcal per day can be consumed.

Vitamin A (retinol palmitate) 900-1350μg RE, vitamin D (cholecalciferol) 8.5-50μg, vitamin E (tocopherol acetate) 7.0-325mg, vitamin K 75μg or more, vitamin B_One(Thiamin chloride hydrochloride) 1.4 mg or more, vitamin B₂(riboflavin) 1.6mg or more, niacin (nicotinamide) 15-125mg, vitamin B₆(Pyridoxine) 1.4~20mg, Vitamin B₁₂(Cyanocobalamin) 2.4μg or more, folic acid 240-450μg, pantothenic acid 6mg or more, biotin 50μg or more, vitamin C (ascorbic acid) 100mg or more, phosphorus 1000-1500mg, iron 11-20mg, zinc 11-15mg, manganese 4.0-5.5mg, copper 0.9-3.5mg, iodine 130~1500μg, selenium 30~175μg, chromium 10~250μg, molybdenum 30~250μg.

In one aspect, the nutritional gel composition of the present embodiment contains less than 2.7 mg of vitamin B ₁ per 900 kcal of the composition.

On the other hand, since potassium may show a tendency to increase blood concentration, it is preferable to lower it than the dietary intake standard from the viewpoint of safety (JJPEN. Vol. 19 No. 6, 1997, p567-633).

The concentration of sodium is 1.5 g in terms of sodium chloride, and less than 6 g in case of sodium restriction due to high blood pressure. Therefore, it is desirable to set the sodium equivalent amount to a maximum of 5 g or less even when consuming an estimated maximum intake of 1500 kcal (hypertension treatment guideline 2009 edition).

For phytonadione, from the viewpoint of preventing medical accidents due to interaction with warfarin, it is preferable to lower than the dietary intake standard from the viewpoint of safety. For the same reason as for vitamin K, it is desirable to blend less than 150 μg, which is the dietary intake standard.

In the gel nutritional composition of this embodiment, it is preferable that the mass ratio (Ca/P) of calcium and phosphorus is 0.74 or more. When Ca/P is 0.74 or more, it is preferable because bone density is significantly higher than when less than 0.74 is blended (Japanese Dietary Intake Standards [2010 Edition], P202).

The energy value of the gel nutritional composition of this embodiment is preferably 0.8 to 1.2 kcal/g, more preferably 0.9 to 1.2 kcal/g, still more preferably 0.95 to 1.1 kcal/g. The energy value can be adjusted within the range of the energy ratio of the various components described above. By adjusting the energy value to 0.9 kcal/g or more, the intake amount can be reduced and the administration time can be shortened, so the burden on the recipient can be reduced.

The gel nutritional composition of this embodiment contains agar, and alginic acid or its salt as a thickener. More specifically, agar is contained in an amount of 0.15% by weight or more and 0.40% by weight or less, preferably 0.20% by weight or more and 0.40% by weight or less, more preferably 0.35% by weight or less, still more preferably 0.30% by weight or less, so that a composition having a viscosity range described later is obtained, and further includes alginic acid or a salt thereof (total in the case of including alginic acid and salts thereof, and alginic acid salts in the case of alginic acid salts). 0.125 wt% or more and 0.40 wt% or less, preferably 0.15 wt% or more and 0.40 wt% or less, more preferably 0.15 wt% or more and 0.35 wt% or less, still more preferably 0.20 wt% or more and 0.30 wt% or less. If the addition amount is small, the gel phase is uniform and in good condition without lumps, and if it is large, the gel is hard and a problem occurs in tube passability. By setting it in a gel form (semi-solid form), the time for energy intake can be reduced, and it is also possible to accelerate recovery by using that amount of time for rehabilitation or the like. The nutritional gel composition of the present embodiment contains agar and alginic acid or a salt thereof within the above range, and may contain other thickeners as long as a predetermined viscosity described later is obtained.

The type of agar is not particularly limited, and Kanten and Kanten powder listed in the Japanese Pharmacopoeia, agar powder as a food material, seal agar, ready-to-use agar, etc. can be used. The types of alginic acid and its salts are not particularly limited, and those of pharmaceutical additive standards or food additive standards can be used. The type of alginate is not particularly limited either, and sodium salts, calcium salts and the like can be used.

The viscosity of the gel nutritional composition of the present embodiment is 3000 to 17000 mPa s, preferably 4000 to 16000 mPa s, more preferably 4500 to 15000 mPa s, still more preferably 5000 to 14000 mPa s, for example, about 5000 to 13000 mPa s. Viscosity means a value measured according to the method specified in <2.53> Viscosity Measurement Method, General Test Methods of the Japanese Pharmacopoeia, 17th Revised. If the viscosity is too low, syneresis is likely to occur, and the shape-retaining force in the stomach is weak, and reflux esophagitis and the like are likely to occur. If the viscosity is too high, the gel is hard, and problems in tube passability tend to occur.

In one aspect, the gel nutritional composition of the present embodiment, by the method described in the following examples, filled a 50 ml catheter tip syringe with about 30 g of the gel nutritional composition sample, attached a 20 Fr. Preferably, it has an extrusion force of 45 N or less, more preferably 40 N or less.

The combination of agar and alginic acid or a salt thereof makes it difficult for the gel to disintegrate even under acidic conditions such as in the stomach and reduces reflux to the esophagus. However, it has been found that when the gel nutrient composition has a high concentration and contains many ions derived from minerals or the like, even if this combination is used simply, a long-term stable gel composition cannot be obtained. In this regard, it was thought that these drawbacks could be eliminated by adding or increasing the amount of the chelating agent. However, upon examination, it was found that destabilization was reversed. As the chelating agent, those selected from citric acid or salts thereof, phosphoric acid or salts thereof, and EDTA or salts thereof may be used, and examples thereof include citrates such as sodium citrate (sodium dihydrogen citrate, disodium citrate, trisodium citrate, etc.), potassium citrate (potassium dihydrogen citrate, dipotassium citrate, tripotassium citrate, etc.), citric acid, potassium phosphate (potassium dihydrogen phosphate, dipotassium phosphate, etc.) , tripotassium phosphate, etc.), phosphates such as sodium phosphate (sodium dihydrogen phosphate, disodium phosphate, trisodium phosphate, etc.), and EDTA can be used. In one aspect, preferably, sodium citrate (sodium dihydrogen citrate, disodium citrate, trisodium citrate, etc.), potassium citrate (potassium dihydrogen citrate, dipotassium citrate, tripotassium citrate, etc.), citric acid, potassium phosphate (potassium dihydrogen phosphate, dipotassium phosphate, tripotassium phosphate, etc.), EDTA can be used as a chelating agent, more preferably, trisodium citrate, A chelating agent selected from tripotassium oxide and dipotassium phosphate can be used.

As for the chelating agent, one type may be used, two types, three types or more may be used. In one embodiment, a combination of citrate and phosphate may be used, for example, sodium citrate (trisodium citrate) and/or potassium citrate and dipotassium phosphate may be used in combination.

The amount of the chelating agent added is 2.0 g or more and 5.7 g or less, preferably 3.0 g or more and 5.7 g or less, more preferably 3.2 g or more and 5.5 g or less, still more preferably 3.4 g or more and 5.3 g or less, particularly preferably 3.6 g or more and 5.1 g or less, for example, 5.0 g or less, per 900 kcal of the composition. If the amount of chelating agent is insufficient, proteolysis may become insufficient. Also, if the amount of the chelating agent is too large, the composition (gel) may become non-uniform.

In addition, in the nutritional composition of this embodiment, the content of phosphoric acid or its salt (for example, dipotassium phosphate) in a chelating agent has a large influence on productivity. For example, when 2.3 g of phosphoric acid or a salt thereof is used per 900 kcal of the composition, even if other chelating agents (eg, sodium citrate (trisodium citrate) and / or potassium citrate) are not included, there is no problem in manufacturability, and a nutritional composition can be produced satisfactorily. In this way, when the chelating agent is phosphoric acid or a salt thereof alone, the content thereof is preferably 2.3 g or more per 900 kcal of the composition from the viewpoint of manufacturability. On the other hand, when phosphoric acid or a salt thereof and another chelating agent (for example, sodium citrate and/or potassium citrate) are combined, the content thereof is preferably 1.1 g or more per 900 kcal of the composition, more preferably 2.3 g or more, from the viewpoint of manufacturability. On the other hand, the upper limit of the content of phosphoric acid or its salt is preferably less than 3.7 g per 900 kcal of the composition from the viewpoint of gel stability. From the above, the content of phosphoric acid or its salt is 1.1 g or more and less than 3.7 g per 900 kcal of the composition from the viewpoint of stability and manufacturability of the composition.

Since the gel nutrient composition of the present embodiment contains a large amount of minerals, etc., it was thought that a corresponding amount of chelating agent was required, but contrary to expectation, by setting the amount of chelating agent within a certain range, a long-term stable gel composition was obtained. From the above viewpoint, the weight ratio of the total amount of magnesium and calcium (in terms of magnesium and calcium): the amount of the chelating agent (in terms of non-hydrate) per 900 kcal of the gel nutritional composition of the present embodiment can be, for example, 1: 4.5 or less, preferably 1: 4.4 or less, more preferably 1: 4.3 or less, and particularly preferably 1: 4.2 or less. In addition, the lower limit is preferably 1:1 or more, more preferably 1:2.4 or more. In one aspect, the weight ratio of the amount of calcium per 100 g of the nutritional gel composition of the present embodiment: chelating agent (in terms of non-hydrate) can be 1: 7.0 or less, preferably 1: 6.5 or less, more preferably 1: 6.0 or less. The lower limit is 1:1 or more, preferably 1:3.4 or more.

One aspect WHEREIN: The gel nutritional composition of this embodiment preferably has a pH higher than 5.5 and is pH 7.0 or lower. If it is out of this range, it tends to become a non-uniform gel, and the reduction of various vitamins during storage may be accelerated.

On the other hand, to the gel nutritional composition of this embodiment, salts different from emulsifiers and chelating agents, fruit juice, flavorings, suspending agents, stabilizers, etc. may be added as needed. For example, as an emulsifier, lecithin, glycerin fatty acid ester, enzymatically decomposed lecithin, sorbitan fatty acid ester, propylene glycol fatty acid ester, sucrose fatty acid ester, etc. can be used alone or in combination.

The gel nutritional composition of this embodiment contains water in addition to components such as the above proteins, lipids, carbohydrates, vitamins and minerals. The manufacturing method of the nutritional gel composition of the present invention is not particularly limited as long as a desired nutritional nutritional composition is obtained, and can be produced as follows, for example.

(1) A liquid nutritional composition is prepared by adding the above proteins, carbohydrates, vitamins, minerals, fats and oils to water or warm water, and emulsifying agents as necessary, and emulsifying with a homogenizer.

(2) A solution of previously heated and dissolved agar and alginic acid or its salt is added and mixed. The chelating agent also functions as a solubilizing agent when added during dissolution of alginic acid or a salt thereof, but the order of administration is not particularly limited as long as a uniform composition is obtained.

(3) If necessary, it is prepared by filling a pouch such as an aluminum pouch or a container such as a soft bag and heat-sterilizing it in a retort or the like. The heat sterilization method may be a conventional method, and a well-known soft synthetic resin, a laminate of paper and metal foil, or the like can be appropriately used for the container.

The order of administration of each component is not particularly limited as long as a uniform desired gel-like nutrient composition is obtained, and a high-pressure homogenizer may be appropriately used at each administration step, if necessary.

The gelled nutrient composition of the present embodiment prepared in this way has no aggregation or precipitation, and is stable without becoming uneven even if stored at room temperature for a long period of time, such as for example 2 weeks or 4 weeks. In this embodiment, that the gel nutrient composition is stable means that there is no aggregation or precipitation after heat sterilization and storage at room temperature for 2 weeks or 4 weeks, and it does not become non-uniform. In one aspect, the gel nutritional composition of this embodiment is stable without becoming uneven even if stored for 13 months at 25°C and 65% RH.

Since the gel-like nutritional composition of this embodiment is gel-like, gastroesophageal reflux can be suppressed, and it is also suitable for an enteral nutritional composition.

Example

Hereinafter, the present invention will be further explained by examples and comparative examples, but the present invention is not limited to the following examples. On the other hand, in the following, when the nutritional composition (formulation) is "heterogeneous", it means that when the gelation is stratified, the local gel of agar is recognized by visual inspection, and/or the hardness is nonuniform. In addition, the nutritional composition in which such a "heterogeneity" was not observed was evaluated as being "stable" (excellent in stability).

(Comparative Example 1: Addition of Vitamins and Minerals to Gel Nutritional Composition)

When preparing a gel-like nutritional composition using soybean protein as protein, enteral semi-solid formulation containing Lacol NF (manufactured and sold by Ien Otsuka Pharmaceutical Co., Ltd.), based on the dietary intake standards for Japanese people (Non-Patent Document 1) for an equivalent amount of 900 kcal, selenium, chromium, molybdenum, choline, Carnitine, and added a standard amount of vitamins and minerals for a day, and when mixed, local gelation occurred and the formulation was not has become uniform In particular, it was considered that local gelation occurred when the calcium concentration and the magnesium concentration increased.

(Comparative Example 2: Gelation of Liquid Nutritional Composition)

Enteral solution containing Inolas (manufactured and sold by EN Otsuka Pharmaceutical Co., Ltd.), which is a liquid nutritional composition, is 1.6 kcal/mL (the amount of whole milk protein per 100 mL is 5.73 g and the amount of casein is 1.91 g). Thereafter, an agar solution dissolved by heating and an alginate solution in which potassium carbonate was dissolved in water as a solubilizing agent were added, and a mixture containing 0.25 g of each of agar and alginic acid per 100 g was added after dissolution. The obtained composition was filled in an aluminum pouch container and sterilized by heat treatment. After preparation, a uniform gel was obtained compared to Comparative Example 1, but partially non-uniform portions were recognized. The amount of whole milk protein per 100 g was 3.58 g, and the amount of casein was 1.19 g. The amount of sodium citrate (trisodium citrate dihydrate) was 2662 mg per 900 kcal. On the other hand, when gelation was attempted without dilution, the properties deteriorated further.

From the results of Comparative Examples 1 and 2, in the method of simply adding vitamins and minerals to the conventional nutritional gel composition, or in the method of gelling the conventional liquid nutritional composition with a gelling agent, it became clear that a gel nutritional composition sufficiently containing vitamins and minerals that is stable and suitable for tube administration could not be obtained.

(Comparative Example 3: Increased amount of sodium citrate 1)

Since the nutritional gel composition of Comparative Example 2 has a high ion concentration, including calcium ions, for the purpose of additional stabilization of the nutritional gel composition, a composition in which sodium citrate as a chelating agent was increased by 1.25 times was prepared in the same manner as in Comparative Example 2 except for the amount of sodium citrate. However, deterioration of properties and stability equivalent or slight to that of Comparative Example 2 was observed.

(Comparative Example 4: Increased amount of sodium citrate 2)

Based on the dietary intake standard, the amount of sodium citrate was further increased (1.56 times that of Comparative Example 2), and a nutritional gel composition was prepared in the same manner as in Comparative Example 3 except for the amount of sodium citrate. Compared to Comparative Example 3, properties and stability were further deteriorated. Also, slight burns were observed during the heat treatment.

(Example)

7.5L of hot water at 40 to 60 ° C, 800g of milk protein concentrate (protein content of about 80%) as whole milk protein, 260g of sodium caseinate (about 90% of protein content) as casein, 540g of emulsifier-containing fat as lipid, 2800g of dextrin as carbohydrate, using a vitamin and mineral mixture of the following composition as vitamins and minerals, the final concentrations are shown in Table 3 PFC ratio, casein : Whole milk protein ratio, Ca/P ratio, Mg concentration, Ca concentration, and energy amount were mixed. 4 g of milk protein concentrate and 1.3 g of casein per 100 g of the final nutritional composition.

Vitamin and mineral mixture, per 900kcal, vitamin A (retinol palmitate): 900μgRE, vitamin B_One(Thiamine Chloride Hydrochloride): 1.4mg, Vitamin B₂(riboflavin): 1.6 mg, B vitamins₆(pyridoxine): 1.4 mg, B vitamins₁₂(Cyanocobalamin): 4.5μg, Vitamin D (cholecalciferol): 15μg, Vitamin E (tocopherol acetate): 22.5mg, Vitamin C (ascorbic acid): 200mg, Niacin (nicotinamide): 15.0mg, Pantothenic acid: 6.0mg, Folic acid: 240μg, Vitamin K: 75μg, Biotin: 5 A mixture of 0.0 μg, phosphorus: 1000 mg, iron: 11.0 mg, zinc: 11.0 mg, copper: 0.9 mg, manganese: 4.0 mg, iodine: 130 μg, selenium: 50.0 μg, chromium: 40.0 μg, molybdenum: 30.0 μg was used.

Calcium and magnesium were added as calcium lactate hydrate and magnesium chloride so as to be the amount shown in Table 1, in total of the parts contained in other components such as whole milk protein. As an example, in the case of Example 2, 998 mg of calcium lactate hydrate and 2828.9 mg of magnesium chloride were added.

It was emulsified with a high-pressure homogenizer, and then, after adding an agar solution dissolved by heating and an alginate solution in which potassium carbonate was dissolved in water as a solubilizing agent, heat treatment was performed to sterilize the mixture, thereby obtaining a gel-like nutrient composition. Agar concentration and alginate concentration were added so that the final concentration was the concentration shown in Table 3. The chelating agent per 900 kcal of the final nutritional composition is as shown in Table 3.

About the obtained composition, the viscosity and extrusion force were measured using the following method. For some compositions, viscosities were also measured after storage at room temperature for 2 weeks and 4 weeks.

[Viscosity measurement]

After storing the nutritional composition at 20° C. for 10 minutes, 20 mL was collected and measured using a single cylindrical rotational viscometer (Japanese Pharmacopoeia General Test Method <2.53> Viscosity Measurement Method, 17th Revised). The viscosities shown in Table 3 and Table 4 were measured with a B-type viscometer, rotational speed of 12 rpm, and 20°C.

[Pressure force measurement]

About 30 g of the gel-like nutritional composition sample was filled with a 50 ml catheter tip syringe (Terumo Co., Ltd.), and a 20 Fr. PEG tube (Badponsky N.B.R. catheter: Medicon Co., Ltd.) was attached to the syringe, and then the compression tester (SV-55C-20H: Imada Manufacturing Co., Ltd.) was used to measure the extrusion force when ejected from the syringe at a speed of 65% (measurement temperature: 20 ° C).

[pH measurement]

Using a pH meter, it was measured based on the pH measurement method <2.54> of the 17th revision of the Japanese Pharmacopoeia.

The obtained gel nutritional composition of Example contains the standard amount of vitamins and minerals for one day in an amount equivalent to 900 kcal, and the viscosity does not decrease even after storage for 4 weeks to 13 months, and extreme water or uneven properties are not observed, and it is a stable composition.

Table 3 also shows various compositions with different PFC ratios and amounts of agar and alginate. In Table 3, the viscosity, extrusion force, and pH show the measured results, and Examples 10-1 to 10-3 are examples created with different production lots. In Example 2, the amount of whole milk protein per 100 g was 3.58 g, and the amount of casein was 1.19 g. The amounts of the chelating agents in Table 3 are all expressed in terms of mg/100g and are values in terms of hydrate. For sodium citrate, trisodium citrate dihydrate (in Japanese Pharmacopoeia, it is written as sodium citrate hydrate), potassium citrate was tripotassium citrate monohydrate, and dipotassium phosphate was anhydrous.

On the other hand, regarding the amount of magnesium, Table 3 shows an example of blending up to 370 mg per 900 kcal, but a larger amount could be easily blended. In addition, since the raw material is of natural origin and the viscosity of the final composition is different depending on the lot, the maximum and minimum values of the measured values are described. Regarding stability, the effect of differences in lots was small.

[Table 3]

About the gel nutritional composition of Example 16 in Table 3, the quantity of agar and alginic acid was changed, and the result of measuring the viscosity is shown in Table 4. The viscosity is an average value of three measurement results.

[Table 4]

The gel nutritional composition of Comparative Example 1 contains soybean protein as a main protein, and a uniform composition was not obtained even when vitamins and minerals were added to it. On the other hand, in the examples, it was thought that a stable gel nutritional composition containing a large amount of minerals such as calcium was obtained by using milk protein concentrate and casein as the main proteins and adjusting the amount of the chelating agent.

The liquid nutrition composition of Comparative Example 2 originally contained many vitamins and minerals, and even if this was gelled, a stable gel nutrition composition was not obtained. In view of the high mineral content, the amount of the chelating agent was increased as in Comparative Examples 3 and 4, but compared to Comparative Example 2, the stability was not improved but deteriorated. On the other hand, in the examples, by adjusting the addition amount and type of protein and the addition amount of minerals, and also finding the amount of gelling agent and chelating agent optimal for gelation, it was thought that a stable gelatinous nutrient composition could be obtained despite containing a large amount of minerals and the like.

Below, the amounts of magnesium, calcium, and chelating agents in typical examples and comparative examples are shown. The total amount of the chelating agent was expressed as an amount not containing a hydrate. On the other hand, in the Examples and Comparative Examples shown in Table 5, the non-hydrate content of dipotassium phosphate was 2749.5mg/900kcal (Inolas combination enteral solution), 2753.4mg/900kcal (Comparative Example 2), 2320.2mg/900kcal (Example 26), and 2663.4mg/900kcal (Example 2). .

[Table 5]

Furthermore, in the same manner as in Example 1, nutritional compositions of each Example and Comparative Example were prepared. Specifically, 7.5L of hot water at 40-60 ° C., 800g of milk protein concentrate (protein content of about 80%) as whole milk protein, 260g of sodium caseinate (about 90% of protein content) as casein, 540g of emulsifier-containing fat as lipid, 2800g of dextrin as carbohydrate, and a vitamin and mineral mixture of the following composition as vitamins and minerals. Casein: Whole milk protein ratio, Ca/P ratio, Mg concentration, Ca concentration, and energy amount were mixed. 4 g of milk protein concentrate and 1.3 g of casein per 100 g of the final nutritional composition.

Vitamin and mineral mixture, per 900kcal, vitamin A (retinol palmitate): 900μgRE, vitamin B_One(Thiamine Chloride Hydrochloride): 1.4mg, Vitamin B₂(riboflavin): 1.6 mg, B vitamins₆(pyridoxine): 1.4 mg, B vitamins₁₂(Cyanocobalamin): 4.5μg, Vitamin D (cholecalciferol): 15μg, Vitamin E (tocopherol acetate): 22.5mg, Vitamin C (ascorbic acid): 200mg, Niacin (nicotinamide): 15.0mg, Pantothenic acid: 6.0mg, Folic acid: 240μg, Vitamin K: 75μg, Biotin: 5 A mixture of 0.0 μg, phosphorus: 1000 mg, iron: 11.0 mg, zinc: 11.0 mg, copper: 0.9 mg, manganese: 4.0 mg, iodine: 130 μg, selenium: 50.0 μg, chromium: 40.0 μg, molybdenum: 30.0 μg was used.

Calcium and magnesium were added as calcium lactate hydrate and magnesium chloride so as to be the amount shown in Table 6, in total of the parts contained in other components such as whole milk protein.

It was emulsified with a high-pressure homogenizer, and then, after adding an agar solution dissolved by heating and an alginate solution in which potassium carbonate was dissolved in water as a solubilizing agent, heat treatment was performed to sterilize the mixture, thereby obtaining a gel-like nutrient composition. Agar concentration and alginate concentration were added so that the final concentration was the concentration shown in Table 6. The chelating agent per 900 kcal of the final nutritional composition is as shown in Table 6.

[Table 6]

Table 6 also shows the amounts of MPC/casein-derived magnesium, calcium, chelating agent, and dipotassium phosphate in Examples and Comparative Examples in Table 6. The total amount of the chelating agent and the amount of dipotassium phosphate were expressed as an amount not containing a hydrate.

[Table 7]

Regarding Tables 6 and 7, in the examples, as a nutritional composition capable of ingesting the daily energy intake, it is possible to mix the daily intake standard amount and recommended amount of vitamins and minerals, and also has excellent gel stability and uniformity. A gel nutritional composition was obtained.

On the other hand, in Comparative Examples 16 and 17, some of the gels were non-uniform, and clogging of the passage due to sediment was observed during the passage of the homogenizer during production, and the productivity was slightly inferior.

Further, in Comparative Examples 7 to 15 and 20, properties and stability were lower than those of Examples. In addition, in Comparative Example 18, clogging of the passage due to sediment was observed during the passage of the homogenizer during production, and the productivity was slightly inferior. Furthermore, the nutrient composition of Comparative Example 19 was frequently observed to clog the passage due to precipitates during passage through the homogenizer during production, and was inferior in productivity.

The gel nutritional composition of the present invention is a stable nutritional composition that can easily consume the daily energy intake, and further contains vitamins and minerals in the recommended daily intake amount and recommended amount. The gel nutritional composition of the present invention has industrial applicability in fields such as medical care, rehabilitation, and nursing care.

Claims (8)

A gel nutritional composition comprising lipids, proteins, carbohydrates, vitamins and minerals and having the following configurations.
1) the energy value of the composition is 0.8 kcal/g or more and 1.2 kcal/g or less;
2) Contains 1.7 g or more of whole milk protein and 0.25 g or more of casein per 100 g of the composition as protein;
3) the total amount of magnesium derived from the whole milk protein and casein is 1.3 mg or more per 900 kcal of the composition, and the total amount of calcium derived from the whole milk protein and casein is 34.9 mg or more per 900 kcal of the composition;
4) contains at least 220 mg of magnesium and at least 500 mg of calcium per 900 kcal of the composition;
5) per 900 kcal of the composition, as a mineral, at least one selected from 30 μg or more of selenium, 10 μg or more of chromium, 30 μg or more of molybdenum, and 130 μg or more of iodine;
6) contains 0.15% by weight or more and 0.40% by weight or less of agar, contains 0.125% by weight or more and 0.40% by weight or less of alginic acid or a salt thereof, and has a viscosity of 3,000 mPa·s or more and 17,000 mPa·s or less;
7) A total of 2.0 g or more and 5.7 g or less of a chelating agent selected from citric acid or a salt thereof, phosphoric acid or a salt thereof, and EDTA or a salt thereof per 900 kcal of the composition, and 1.1 g or more and less than 3.7 g of the phosphoric acid or salt thereof per 900 kcal of the composition. According to claim 1,
The ratio of the casein and the whole milk protein is 1: 1.1 to 1: 13 in the weight ratio of the protein contained, the gel nutritional composition. According to claim 1 or 2,
The gel nutritional composition in which the said whole milk protein is a milk protein concentrate. According to any one of claims 1 to 3,
A gel-like nutritional composition that does not contain animal protein degradation products and vegetable protein degradation products. According to any one of claims 1 to 4,
The lipid content in the composition is 20% or more and 30% or less in terms of energy ratio,
The protein content in the composition is 13% or more and 30% or less in terms of energy ratio,
A gel nutritional composition in which the carbohydrate content in the composition is 50% or more and 65% or less in terms of energy ratio. According to any one of claims 1 to 5,
A nutritional gel composition comprising 310 mg or more of magnesium and 650 mg or more of calcium per 900 kcal of the composition. According to any one of claims 1 to 6,
A gel nutritional composition containing at least the following vitamins and minerals per 900 kcal of the composition.
[Table 1]
According to any one of claims 1 to 7,
A nutritional gel composition having a pH higher than 5.5 and lower than or equal to pH 7.0 and a ratio of the total amount of magnesium and calcium: the amount of chelating agent per 900 kcal of the composition of 1:4.5 or lower.