Compositions for preventing or treating anemia, composition for preventing increase or decrease in blood hemoglobin concentration, and composition for preventing increase or decrease in red blood cell count in blood

Abstract

To provide compositions for preventing or treating anemia.SOLUTION: The present art provides a composition for preventing or treating anemia, which contains carnitine and vitamin D. The art also provides a composition for preventing an increase or decrease in blood hemoglobin concentration, which contains carnitine and vitamin D. The art also provides a composition for preventing an increase or decrease in red blood cell count in blood, which contains carnitine and vitamin D. These compositions may further contain zinc. These compositions may be composed, for example, as food and beverage compositions. Alternatively, these compositions may be composed as pharmaceutical compositions.SELECTED DRAWING: None

Description

[Technical field]

[0001] The present technology relates to a composition for preventing or treating anemia, a composition for preventing an increase or decrease in blood hemoglobin concentration, and a composition for preventing an increase or decrease in blood red blood cell count. [Background technology]

[0002] Anemia occurs when the hemoglobin concentration or red blood cell count in the blood decreases. Hemoglobin and red blood cells containing hemoglobin serve to deliver oxygen to various parts of the body. Therefore, when the hemoglobin concentration or red blood cell count decreases, various parts of the body become oxygen-deficient, and symptoms of anemia appear. Examples of symptoms of anemia include lightheadedness, shortness of breath, dizziness, lightheadedness, palpitations, fatigue, and pale complexion.

[0003] Iron preparations are often used as a method for preventing or treating anemia, but the use of ingredients other than iron preparations has also been proposed. For example, Patent Document 1 below discloses a "composition for preventing or treating anemia, the active ingredient of which is bacteria belonging to the genus Bifidobacterium." [Prior art documents] [Patent documents]

[0004] [Patent Document 1] International Publication No. 2011 / 114916 Summary of the Invention [Problem to be solved by the invention]

[0005] Anemia occurs in subjects of various ages, but for example, the elderly are more prone to anemia. The age-related decline in the ability to produce hemoglobin or red blood cells and the presence of diseases that cause anemia can contribute to anemia in the elderly.

[0006] In addition, elderly people may not be able to take in sufficient nutrition, and therefore a composition that allows them to take in nutrition while preventing or treating anemia would be extremely useful.

[0007] In light of the above, the present technology aims to provide a new method for treating anemia and also to provide a new method for increasing the hemoglobin concentration or red blood cell count in blood. [Means for solving the problem]

[0008] The inventors have found that certain compositions can address anemia, and that certain compositions can increase the hemoglobin concentration or red blood cell count in the blood.

[0009] That is, the present technology provides the following: [1] A composition for preventing or treating anemia, comprising carnitine and vitamin D. [2] A composition for increasing or preventing a decrease in blood hemoglobin concentration, comprising carnitine and vitamin D. [3] A composition for increasing or preventing a decrease in red blood cell count, comprising carnitine and vitamin D. [4] The composition described in any one of [1] to [3], wherein the composition is administered so that the daily dose of the carnitine is 500 mg or less. [5] The composition described in any one of [1] to [3], wherein the composition is administered so that the daily dose of vitamin D is 3 μg or more. [6] The composition according to any one of [1] to [3], further comprising zinc. [7] The composition according to [6], wherein the composition is administered so that the daily dosage of the zinc is 5 mg or more. [8] The composition described in any one of [1] to [7], which is administered to a patient receiving tube feeding. [9] The composition described in any one of [1] to [8], wherein the composition is a food or beverage composition.

[10] The composition according to any one of [1] to [8], wherein the composition is a pharmaceutical composition. Effect of the Invention

[0010] This technology can prevent or treat anemia. It can also increase either or both of the hemoglobin concentration and the red blood cell count in blood, or prevent a decrease in either or both of the hemoglobin concentration and the red blood cell count in blood. Moreover, the active ingredients in the composition according to the present technology are also nutrients that are useful to the body, and therefore the present technology can prevent or treat anemia, or increase or prevent a decrease in either or both of the hemoglobin concentration or red blood cell count in the blood, while providing the nutrients. Note that the effects of the present technology are not limited to the effects described here, and may be any of the effects described in this specification. [Brief description of the drawings]

[0011] [Figure 1] 1 is a graph showing the analysis results regarding blood components. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] Preferred embodiments of the present technology will be described below. However, the present technology is not limited to the following preferred embodiments and can be freely modified within the scope of the present technology.

[0013] The composition of the present technology includes carnitine and vitamin D. The composition including carnitine and vitamin D is suitable for treating or preventing anemia. That is, the present technology provides a composition for preventing or treating anemia, including carnitine and vitamin D. In addition, the composition including carnitine and vitamin D can increase or prevent a decrease in blood hemoglobin concentration and / or red blood cell count. That is, the present technology also provides a composition for increasing or preventing a decrease in blood hemoglobin concentration and a composition for increasing or preventing a decrease in blood red blood cell count, including carnitine and vitamin D.

[0014] Both carnitine and vitamin D contained in the composition of the present technology are useful nutritional components. Therefore, the composition of the present technology can replenish these nutritional components, and can prevent or treat anemia, increase blood hemoglobin concentration or blood red blood cell count, or prevent a decrease in blood hemoglobin concentration or blood red blood cell count.

[0015] In a preferred embodiment of the present technology, the composition further comprises zinc. The combination of carnitine, vitamin D, and zinc is useful for preventing or treating anemia or increasing or preventing a decrease in hemoglobin concentration or red blood cell count in the blood.

[0016] In this specification, "anemia" may mean a state in which the concentration of hemoglobin in blood is low. Symptoms of anemia may include one or more of the following: dizziness, shortness of breath, dizziness, lightheadedness, headache, and chest pain. Anemia may be, for example, any one of senile anemia; renal anemia; iron deficiency anemia; anemia due to chronic infection, chronic inflammation, or malignant tumor; anemia due to blood loss (chronic anemia due to blood loss or acute anemia due to blood loss); secondary anemia; vitamin B12 deficiency anemia; folic acid deficiency anemia; aplastic anemia; and hemolytic anemia, or a combination of multiple anemias. Anemia may be any one, two, or three of senile anemia, hemolytic anemia, and anemia due to chronic inflammation, which are considered to be closely related to carnitine and vitamin D.

[0017] As used herein, "prevention of anemia" may include preventing anemia from occurring, reducing the risk of developing anemia, reducing the likelihood of developing anemia, preventing at least one symptom of anemia from appearing, reducing the risk of developing at least one symptom of anemia, and reducing the likelihood of developing at least one symptom of anemia, and may mean one or more of these.

[0018] As used herein, "treatment of anemia" may include reducing the severity of anemia, improving an anemic state to a normal state, preventing anemia from worsening, alleviating at least one of the symptoms of anemia, and reducing the frequency of occurrence of at least one of the symptoms of anemia, and may mean one or more of these.

[0019] In the present specification, "increasing blood hemoglobin concentration" may literally mean increasing blood hemoglobin concentration. In the present specification, "preventing a decrease in blood hemoglobin concentration" may include preventing a decrease in blood hemoglobin concentration, inhibiting a decrease in blood hemoglobin concentration, and maintaining blood hemoglobin concentration, and may mean one or more of these.

[0020] Similarly, in the present specification, "increasing the number of red blood cells in the blood" may literally mean increasing the number of red blood cells in the blood. In the present specification, "preventing a decrease in the number of red blood cells in the blood" may include preventing a decrease in the number of red blood cells in the blood, inhibiting a decrease in the number of red blood cells in the blood, and maintaining the number of red blood cells in the blood, and may mean one or more of these.

[0021] The compositions of the present technology are described in more detail below.

[0022] (1) Carnitine The composition of the present technology includes carnitine. The carnitine may be L-carnitine. The carnitine may be included in the composition of the present technology as a carnitine salt, which may include the tartrate and fumarate salts of carnitine.

[0023] Carnitine exerts, for example, the action of promoting ATP production, the action of maintaining the free CoA pool, the action of an endogenous detoxifier (e.g., acyl-CoA excretion), the action of enhancing the expression of antioxidant enzymes, the action of inhibiting apoptosis, the action of antioxidants, the action of anti-inflammatory agents, the action of stabilizing biomembranes, and the action of inhibiting fibrosis, etc. Since the composition of the present technology contains carnitine, it may be used to exert any one or more of these actions, and to prevent or treat anemia, or to increase or prevent a decrease in blood hemoglobin concentration or blood red blood cell count.

[0024] The composition of the present technology may be administered to a subject so that the daily dose of the carnitine is 500 mg or less, and in particular, the daily dose is 450 mg or less, 400 mg or less, 350 mg or less, 300 mg or less, 250 mg or less, or 200 mg or less. The lower limit of the daily dose may be, for example, 10 mg or more, 30 mg or more, 50 mg or more, or 100 mg or more. The range of the daily dose of carnitine may be a combination of the upper and lower limits listed above, for example, 10 mg or more and 500 mg or less, particularly 30 mg or more and 400 mg or less, and more particularly 50 mg or more and 300 mg or less. For example, when carnitine is administered to treat carnitine deficiency, the daily dosage is set to be more than 500mg. The carnitine contained in the composition of the present technology may be administered at a lower dosage compared to such dosage. Even if the daily dosage of carnitine is so low, the composition of the present technology is still useful for preventing or treating anemia, or for increasing or preventing a decrease in hemoglobin concentration or red blood cell count in blood.

[0025] The content of the carnitine may be, for example, 50 mg or less, 45 mg or less, 40 mg or less, 35 mg or less, 30 mg or less, 25 mg or less, or 20 mg or less per 100 kcal of the energy content of the composition of the present technology. The content of the carnitine may be, for example, 1 mg or more, 3 mg or more, 5 mg or more, or 10 mg or more per 100 kcal of the energy content of the composition. This numerical range of the content may be applied, for example, when the composition of the present technology is in a liquid, paste, jelly, powder, or solid form.

[0026] (2) Vitamin D The composition of the present technology includes vitamin D. The vitamin D may be vitamin D2 (ergocalciferol) or vitamin D3 (cholecalciferol), or a combination of vitamins D2 and D3. The vitamin D is particularly preferably vitamin D3.

[0027] Vitamin D exerts, for example, an effect of promoting calcium and phosphorus absorption in the intestinal tract and an effect of promoting calcium and phosphorus accumulation in bones, etc. Since the composition of the present technology contains vitamin D, it may be used to exert one or more of these effects, and to prevent or treat anemia, or to increase or prevent a decrease in blood hemoglobin concentration or blood red blood cell count.

[0028] The composition of the present technology may be administered to a subject such that the daily dose of vitamin D is 3 μg or more, and in particular, the daily dose is 5 μg or more, 6 μg or more, or 7 μg or more. The upper limit of the daily dose may be, for example, 100 μg or less, 80 μg or less, 60 μg or less, 40 μg or less, or 20 μg or less. The numerical range of the daily dose of vitamin D may be a combination selected from the upper and lower limits listed above, for example, 3 μg or more and 100 μg or less, particularly 5 μg or more and 80 μg or less, more particularly 6 μg or more and 60 μg or less, and even more particularly 7 μg or more and 40 μg or less.

[0029] The content of vitamin D may be, for example, 0.3 μg or more, 0.5 μg or more, 0.6 μg or more, or 0.7 μg or more per 100 kcal of energy of the composition of the present technology. The content of vitamin D may be, for example, 10 μg or less, 8 μg or less, 6 μg or less, 4 μg or less, or 2 μg or less per 100 kcal of energy of the composition. This numerical range of content may be applied, for example, to the liquid, paste, jelly, powder, or solid form of the present technology.

[0030] (3) Zinc The composition of the present technology may further include zinc in addition to carnitine and vitamin D. The zinc may be included in the composition of the present technology as, for example, a zinc-containing compound or a zinc-containing microbial material. The zinc-containing compound may include organic zinc or inorganic zinc. The organic zinc may include, for example, zinc gluconate and zinc amino acid. The inorganic zinc may include, for example, zinc sulfate, zinc oxide, zinc acetate, zinc tartrate, and zinc lactate. The zinc-containing microbial material may also be, for example, yeast, particularly zinc-containing yeast powder or zinc-containing yeast extract. The zinc-containing yeast is obtained by culturing yeast in a medium containing zinc (e.g., one or more of zinc sulfate, zinc chloride, zinc citrate, zinc acetate, zinc tartrate, and zinc lactate). The yeast may be, for example, Saccharomyces, Mycotorula, or Torulopsis. The yeast may be an edible yeast, such as baker's yeast, brewer's yeast, wine yeast, sake yeast, alcohol yeast, or miso / soy sauce yeast.

[0031] The composition of the present technology may be administered to a subject such that the zinc is administered in a daily dose of 5 mg or more, particularly in a daily dose of 6 mg or more, 7 mg or more, 8 mg or more, 9 mg or more, 10 mg or more, or 11 mg or more. The upper limit of the daily dose may be, for example, 45 mg or less, 35 mg or less, 25 mg or less, 20 mg or less, or 15 mg or less. The range of the daily dose of zinc may be a combination of the upper and lower limits listed above, and may be, for example, 5 mg or more and 45 mg or less, particularly 7 mg or more and 35 mg or less, more particularly 10 mg or more and 20 mg or less, and even more particularly 11 mg or more and 15 mg or less.

[0032] The content of zinc may be, for example, 0.5 mg or more, 0.6 mg or more, 0.7 mg or more, 0.8 mg or more, 0.9 mg or more, 1 mg or more, or 1.1 mg or more per 100 kcal of the energy amount of the composition of the present technology. Also, the content of zinc may be, for example, 4.5 mg or less, 3.5 mg or less, 2.5 mg or less, 2 mg or less, or 1.5 mg or less per 100 kcal of the energy amount of the composition. This numerical range of the content may be applied, for example, when the composition of the present technology is in a liquid, paste, jelly, powder, or solid form.

[0033] (4) Other ingredients The composition of the present technology may further include other ingredients. Examples of the other ingredients include dietary fiber, vitamins other than vitamin D, proteins, lipids, amino acids, oligosaccharides, and minerals. The composition of the present technology may include one or more of these other ingredients.

[0034] The compositions of the present technology may further include, for example, dietary fiber, which may be soluble dietary fiber, insoluble dietary fiber, or a combination of soluble and insoluble dietary fiber. The water-soluble dietary fiber may include, for example, one or more of resistant dextrin, guar gum and its hydrolyzates, polydextrose, inulin, pectin, carrageenan, alginic acid and its hydrolyzates, agar, xanthan gum, locust bean gum, gellan gum, gum arabic, soybean polysaccharides, and glucomannan, and in particular, the water-soluble dietary fiber is resistant dextrin. The insoluble dietary fiber may include, for example, any one or more of cellulose, microcrystalline cellulose, fermented cellulose, hemicellulose, lignin, and chitin, and in particular the insoluble dietary fiber is cellulose.

[0035] The composition of the present technology may be administered to a subject such that the dietary fiber is administered in a daily dose of 10 g or more, particularly 15 g or more or 20 g or more. The upper limit of the daily dose may be, for example, 50 g or less, 45 g or less, or 40 g or less. In addition, the composition of the present technology may be administered to a subject so that the daily dose of the resistant dextrin is 2 g or more, and in particular, the daily dose is 9 g or more or 18 g or more. The upper limit of the daily dose may be, for example, 45 g or less, 40 g or less, or 35 g or less.

[0036] The content of the dietary fiber may be, for example, 1 g or more, 1.5 g or more, or 2 g or more per 100 kcal of energy of the composition of the present technology. Also, the content of the dietary fiber may be, for example, 5 g or less, 4.5 g or less, or 4 g or less per 100 kcal of energy of the composition. The content of the resistant dextrin per 100 kcal of the energy content of the composition of the present technology may be, for example, 0.2 g or more, 0.9 g or more, or 1.8 g or more. Also, the content of the resistant dextrin per 100 kcal of the energy content of the composition may be, for example, 4.5 g or less, 4 g or less, or 3.5 g or less. These numerical ranges of the content may be applied, for example, when the composition of the present technology is in a liquid, paste, jelly, powder or solid form.

[0037] The composition of the present technology may further include vitamins other than vitamin D. The vitamins may include, for example, any one or more of vitamin A, vitamin B (e.g., vitamin B1, vitamin B2, vitamin B6, niacin, pantothenic acid, biotin, vitamin B12, folic acid, etc.), vitamin C, and vitamin E, particularly vitamins B, C, and E, and more particularly vitamins B1, C, and E.

[0038] The composition of the present technology may be administered to a subject so that the daily dose of vitamin B1 is 1 mg or more, particularly 2 mg or more, or 3 mg or more. The upper limit of the daily dose may be, for example, 10 mg or less, 9 mg or less, or 8 mg or less. The composition of the present technology may be administered to a subject so that the daily dose of vitamin C is 50 mg or more, particularly 100 mg or more, or 300 mg or more. The upper limit of the daily dose may be, for example, 2000 mg or less, 1900 mg or less, or 1800 mg or less. The composition of the present technology may be administered to a subject so that the daily dose of vitamin E is 8 mg or more, and in particular, the daily dose is 20 mg or more, or 30 mg or more. The upper limit of the daily dose may be, for example, 200 mg or less, 190 mg or less, or 180 mg or less.

[0039] The content of vitamin B1 may be, for example, 0.1 mg or more, 0.2 mg or more, or 0.3 mg or more per 100 kcal of energy of the composition of the present technology. Also, the content of vitamin B1 may be, for example, 1 mg or less, 0.9 mg or less, or 0.8 mg or less per 100 kcal of energy of the composition. The content of vitamin C may be, for example, 5 mg or more, 10 mg or more, or 30 mg or more per 100 kcal of energy of the composition of the present technology. Also, the content of vitamin C may be, for example, 200 mg or less, 190 mg or less, or 180 mg or less per 100 kcal of energy of the composition. The content of vitamin E may be, for example, 1 mg or more, 2 mg or more, or 3 mg or more per 100 kcal of the energy content of the composition of the present technology. Also, the content of vitamin E may be, for example, 20 mg or less, 19 mg or less, or 18 mg or less per 100 kcal of the energy content of the composition. These numerical ranges of the content may be applied, for example, when the composition of the present technology is in a liquid, paste, jelly, powder or solid form.

[0040] The composition of the present technology may further contain a protein. The protein is not particularly limited as long as it is used in food, such as animal proteins such as milk proteins, egg proteins, and collagen, and vegetable proteins such as soybean proteins, rice proteins, and wheat proteins. In the present invention, milk proteins are particularly preferably used. As milk proteins, casein hydrolysates, caseinates such as sodium caseinate and calcium caseinate, milk protein concentrate (MPC), whey protein concentrate (WPC), whey protein hydrolysates, etc. can be used.

[0041] The composition of the present technology may be administered to a subject such that the daily dose of the protein is 10 g or more, particularly 15 g or more, or 20 g or more, with the upper limit of the daily dose being, for example, 80 g or less, 70 g or less, or 60 g or less. The composition of the present technology may be administered to a subject such that the daily dose of the milk protein is 10 g or more, particularly 15 g or more or 20 g or more, with the upper limit of the daily dose being, for example, 80 g or less, 70 g or less, or 60 g or less.

[0042] The protein content may be, for example, 1 g or more, 1.5 g or more, or 2 g or more per 100 kcal of energy of the composition of the present technology. Also, the protein content may be, for example, 8 g or less, 7 g or less, or 6 g or less per 100 kcal of energy of the composition. The casein content may be, for example, 1 g or more, 1.5 g or more, or 2 g or more per 100 kcal of energy of the composition, and may be, for example, 8 g or less, 7 g or less, or 6 g or less per 100 kcal of energy of the composition. These numerical ranges of the content may be applied, for example, when the composition of the present technology is in a liquid, paste, jelly, powder or solid form.

[0043] The composition of the present technology may further contain lipids. The lipids may be any oils and fats used in food, such as vegetable oils such as soybean oil, rapeseed oil, corn oil, and animal oils such as fish oil, without any particular limitations. Among them, vegetable oils are preferably used, and soybean oil is more preferably used. The lipids may also contain medium-chain fatty acid triglycerides. They may also contain EPA and / or DHA.

[0044] The composition of the present technology may be administered to a subject such that the lipid is administered in a daily dose of 10 g or more, particularly 12 g or more, or 14 g or more. The upper limit of the daily dose may be, for example, 50 g or less, 45 g or less, or 40 g or less. The composition of the present technology may be administered to a subject so that the daily dose of EPA is 100 mg or more, particularly 120 mg or more or 150 mg or more. The upper limit of the daily dose may be, for example, 600 mg or less, 500 mg or less, or 400 mg or less. The composition of the present technology may be administered to a subject so that the daily dose of DHA is 50 mg or more, particularly 100 mg or more, or 120 mg or more. The upper limit of the daily dose may be, for example, 500 mg or less, 380 mg or less, or 250 mg or less.

[0045] The lipid content may be, for example, 1 g or more, 1.2 g or more, or 1.4 g or more per 100 kcal of energy of the composition of the present technology, and may be, for example, 5 g or less, 4.5 g or less, or 4 g or less per 100 kcal of energy of the composition. The EPA content may be, for example, 12 mg or more or 15 mg or more per 100 kcal of energy of the composition, and may be, for example, 60 mg or less, 50 mg or less, or 40 mg or less per 100 kcal of energy of the composition. The content of DHA per 100 kcal of energy of the composition may be, for example, 5 mg or more, 10 mg or more, or 12 mg or more. Also, the content of DHA per 100 kcal of energy of the composition may be, for example, 50 mg or less, 38 mg or less, or 25 mg or less. These numerical ranges of the content may be applied, for example, when the composition of the present technology is in a liquid, paste, jelly, powder or solid form.

[0046] The composition of the present technology may further comprise amino acids. The amino acids may be, for example, one or a combination of two or more selected from valine, leucine, isoleucine, glutamine, aspartic acid, glutamic acid, arginine, alanine, proline, cysteine, lysine, threonine, asparagine, phenylalanine, serine, methionine, glycine, tyrosine, histidine, and tryptophan. Preferably, the amino acids include one, two, or three selected from valine, leucine, and isoleucine.

[0047] The composition of the present technology may be administered to a subject such that the total daily dose of the amino acids is 10 g or more, particularly 12 g or more, or 14 g or more. The upper limit of the total daily dose may be, for example, 40 g or less, 35 g or less, or 30 g or less.

[0048] The total content of the amino acids may be, for example, 1 g or more, 1.2 g or more, or 1.4 g or more per 100 kcal of energy of the composition of the present technology, and may be, for example, 4 g or less, 3.5 g or less, or 3 g or less per 100 kcal of energy of the composition. These numerical ranges of the content may be applied, for example, when the composition of the present technology is in a liquid, paste, jelly, powder or solid form.

[0049] The composition of the present technology may further include a carbohydrate. As the carbohydrate, any carbohydrate used in food, such as monosaccharides, disaccharides, oligosaccharides, polysaccharides, etc., may be used without any particular limitation. Among them, polysaccharides and oligosaccharides may be preferably used. As the polysaccharide, dextrin may be more preferably used. The oligosaccharide may include, for example, one or more of disaccharides, trisaccharides, tetrasaccharides, and pentasaccharides. An example of the oligosaccharide may be lactulose.

[0050] The composition of the present technology may be administered to a subject such that the carbohydrate is administered in a daily dose of 80 g or more, particularly 100 g or more, or 120 g or more. The upper limit of the daily dose may be, for example, 250 g or less, 200 g or less, or 180 g or less.

[0051] The total content of the carbohydrates may be, for example, 8 g or more, 10 g or more, or 12 g or more per 100 kcal of energy of the composition of the present technology. Also, the total content of the carbohydrates may be, for example, 25 g or less, 20 g or less, or 15 g or less per 100 kcal of energy of the composition.

[0052] The composition of the present technology may further include a mineral. Examples of minerals include calcium, magnesium, phosphorus, iron, zinc, copper, manganese, iodine, selenium, chromium, and molybdenum. The composition of the present technology may include one or more of these minerals.

[0053] The composition of the present technology may contain components such as water, sweeteners, fruit juice, vegetable juice, flavors, colorants, and acidulants. The types and content ratios of these components may be appropriately selected by those skilled in the art depending on the desired physical properties, shape, taste, or appearance.

[0054] (5) Physical properties of the composition The composition of the present technology may be in the form of a liquid, paste, gel (jelly), powder or solid, preferably in the form of a liquid or gel, and more preferably in the form of a liquid.

[0055] The composition of the present technology is preferably flowable. For example, it may be a flowable liquid or gel composition. For example, the composition of the present technology may be a liquid food.

[0056] The composition of the present technology is liquid, which makes it easy for elderly people to take, and can be administered to a subject via a tube. When the composition of the present technology is liquid, various physical properties of the composition may be set, for example, as follows.

[0057] The osmotic pressure of the liquid composition of the present technology may be, for example, 100 mOsm / L to 1000 mOsm / L, preferably 200 mOsm / L to 500 mOsm / L, and more preferably 250 mOsm / L to 350 mOsm / L.

[0058] The pH of the liquid composition of the present technology at 20° C. may be, for example, 6.0 to 8.0, preferably 6.3 to 7.7, and more preferably 6.5 to 7.5.

[0059] The specific gravity of the composition of the present technology at 20° C. may be, for example, 0.8 to 1.5, preferably 0.9 to 1.4, and more preferably 1.0 to 1.2.

[0060] The viscosity of the composition of the present technology at 20° C. may be, for example, 1 mPa·s to 30,000 mPa·s, preferably 5 mPa·s to 1,800 mPa·s, and more preferably 10 mPa·s to 100 mPa·s.

[0061] In one embodiment of the present technology, the energy content per 1 ml of the composition of the present technology can be 0.5 kcal or more, 0.6 kcal or more, 0.7 kcal or more, 0.8 kcal or more, or 0.9 kcal or more.In this way, the high energy content per 1 ml of the composition allows efficient energy intake.In this embodiment, the energy content per 1 ml of the composition of the present technology can be, for example, 5 kcal or less, 4 kcal or less, 3 kcal or less, 2 kcal or less, or 1.5 kcal or less.For example, the composition of the present technology can have an energy content of 1 kcal per 1 ml. In this embodiment, the composition of the present technology may be, for example, in liquid, paste, gel (jelly), powder or solid form.

[0062] (6) Food and drink composition The composition of the present technology can be used as a food and drink composition. The food and drink composition of the present technology may have a form such as liquid, paste, jelly, solid, or powder. The food and drink composition of the present technology may be configured as, for example, tablet confectionery, liquid food, or feed (including for pets). The food and drink composition of the present technology may be configured as, for example, flour products, instant foods, processed agricultural products, processed marine products, processed livestock products, milk and dairy products, oils and fats, basic seasonings, complex seasonings and foods, frozen foods, confectioneries, or beverages.

[0063] In addition, the food and beverage composition of the present technology can be provided or sold as a food and beverage labeled with uses (including health uses) such as prevention and / or treatment of anemia, reduction of the risk of anemia, prevention and / or treatment of anemia symptoms, or increase in blood hemoglobin concentration or blood red blood cell count. In addition, the food and beverage composition of the present technology can be provided and / or sold with a label indicating, for example, "people with anemia," "people prone to anemia," "people concerned about the risk of anemia," "people who wish to increase hemoglobin concentration," "helpful for maintaining physical condition by increasing hemoglobin concentration," "helpful for maintaining physical condition by increasing red blood cell count," or "people who wish to increase red blood cell count." The act of "labeling" includes all acts for informing consumers of the use of the composition of the present technology, and any expression that can recall and / or infer the above-mentioned use falls under the act of "labeling" of the present technology, regardless of the purpose of the labeling, the content of the labeling, the object and / or medium on which it is displayed.

[0064] Furthermore, it is preferable that the "labeling" be done in an expression that allows consumers to directly recognize the above-mentioned uses.Specific examples include the act of transferring, delivering, displaying for the purpose of transferring or delivering, or importing food and beverage products or product packaging on which the above-mentioned uses are written, displaying or distributing advertisements, price lists, or transaction documents related to the products and writing the above-mentioned uses in information containing the above-mentioned uses and providing them by electromagnetic means (such as the Internet), etc.

[0065] On the other hand, the content of the labeling is preferably a labeling approved by the government etc. (for example, a labeling approved based on various systems established by the government and made in a manner based on such approval, etc.) In addition, it is preferable that such a labeling content is affixed to the packaging, containers, catalogs, pamphlets, POP and other sales site promotional materials, other documents, etc.

[0066] In addition, "labeling" also includes labeling as health food, functional food, enteral nutrition food, special purpose food, health functional food, food for specified health uses, nutrient functional food, functional food, functional labeling food, medical drug, etc. Among these, in particular, labeling approved by the Consumer Affairs Agency, for example, labeling approved under the system related to food for specified health uses, nutrient functional food, or functional labeling food, or a similar system, etc., can be mentioned. Specifically, labeling as food for specified health uses, labeling as food for conditional specified health uses, labeling that affects the structure or function of the body, labeling for reducing disease risk, labeling of functionality based on scientific evidence, etc., can be mentioned, and more specifically, labeling as food for specified health uses (especially labeling of health uses) and similar labeling as specified in the Cabinet Office Ordinance on the Permission of Labeling for Special Uses Prescribed in the Health Promotion Act (Cabinet Office Ordinance No. 57 of August 31, 2009) are typical examples.

[0067] (7) Pharmaceutical composition The composition of the present technology can be used as a pharmaceutical composition. The pharmaceutical composition of the present technology can be used to prevent or treat anemia. In addition, the pharmaceutical composition of the present technology can be used to increase or prevent a decrease in blood hemoglobin concentration or blood red blood cell count, or both.

[0068] When the composition according to the present technology is used as a pharmaceutical composition, the pharmaceutical composition may be administered orally or parenterally, and may be formulated into a desired dosage form according to the administration method. For example, in the case of oral administration, the composition may be formulated into solid preparations such as powders, granules, tablets, and capsules; or liquid preparations such as solutions, syrups, suspensions, and emulsions. In addition, in the case of parenteral administration, the composition according to the present technology may be administered, for example, via a gastrostomy tube.

[0069] In addition, when preparing a formulation, the pharmaceutical composition according to the present technology can contain ingredients that are normally used in formulations, such as excipients, pH adjusters, colorants, flavorings, etc. In addition, as long as the effects of the present technology are not impaired, ingredients that have known or will be discovered in the future and have the effect of preventing, improving, and / or treating anemia or symptoms thereof can also be used in the pharmaceutical composition according to the present technology. In addition, formulation can be carried out by a known method as appropriate depending on the dosage form. When preparing the formulation, a pharmaceutical carrier may be appropriately added to the formulation.

[0070] (8) Method for producing the composition The method for producing the composition of the present technology includes a mixing step of mixing carnitine and vitamin D, and optionally zinc. In the mixing step, these components may be mixed in any medium, such as a liquid medium. In the mixing step, other optional components contained in the composition of the present technology, such as zinc, may be further mixed. The zinc may be added as a zinc-containing compound or a zinc-containing microbial material, as described above. In the mixing step, a composition having the composition as the final product may be formed.

[0071] The mixing step may include a sterilization step of sterilizing the resulting composition, which may be performed by any method known in the art, such as high temperature short time sterilization (HTST), UHT (ultra high temperature sterilization), pressure heat sterilization, etc.

[0072] The method may further include a step of filling a container with the composition obtained in the mixing step before or after the sterilization step. When the filling step is performed after the sterilization step, the filling step may be performed aseptically. The container may be, for example, a paper pack, a plastic bag, a plastic bottle, a plastic cup, an aluminum pouch, a metal can, or a glass container.

[0073] (9) Method of using the composition The subject of administration of the composition of the present technology may be an animal, particularly a mammal, more particularly a primate, even more particularly a human or non-human primate, and particularly preferably a human. When the subject of administration of the composition of the present technology is a human, the age of the human is, for example, 0 to 120 years old, preferably 60 years old or older, more preferably 65 years old or older, even more preferably 70 years old or older, 75 years old or older, or 80 years old or older. The composition of the present technology is particularly suitable for dealing with anemia in such elderly people. In addition, the composition of the present technology is particularly suitable for preventing an increase or decrease in hemoglobin concentration and / or red blood cell count in the blood of such elderly people.

[0074] The compositions of the present technology may be used to administer to a human in need of, for example, prevention or treatment of anemia, or in need of an increase in blood hemoglobin concentration or blood red blood cell count. The human may be, for example, a patient with a disease that may present with anemia symptoms. The human may be, for example, a patient suffering from diabetes.

[0075] The composition of the present technology may be taken, for example, orally or by tube feeding. In the latter case, the composition of the present technology is administered to a human, for example, via a gastrostomy tube. That is, the composition of the present technology may be administered to a tube-fed patient. For administration to a tube-fed patient, the composition of the present technology may have, for example, a liquid form.

[0076] In one embodiment of the present technology, the composition of the present technology may be administered so that the composition of the present technology provides an amount of energy of, for example, 500 kcal to 2000 kcal, preferably 600 kcal to 1500 kcal, preferably 800 kcal to 1200 kcal per day to the subject. For example, the composition of the present technology may provide an amount of energy of 200 kcal to 500 kcal per administration to the subject, and the administration may be performed 1 to 10 times, 2 to 8 times, or 2 to 5 times per day. The composition of the present technology may be administered periodically, for example, daily, or may be administered at intervals, such as every other day or every two days. The composition of the present technology may be administered, for example, for one week or more, two weeks or more, or three weeks or more, and preferably for one month or more, two months or more, or three months or more. The composition of the present technology may not have an upper limit on the administration period, and may be, for example, 3 years or less, 2 years or less, or 1 year or less, or may be administered without a set end time for the administration period.

[0077] (10) Examples of nutritional composition of the composition An example of the nutritional composition per 100 kcal of the composition of the present technology is given below.

[0078] The composition of the present technology may contain 13 g to 20 g, preferably 14 g to 18 g, of carbohydrates per 100 kcal of energy contained in the composition.

[0079] The composition of the present technology may contain, for example, 70 mg to 100 mg, and preferably 80 mg to 90 mg, of sodium per 100 kcal of energy contained in the composition. The composition of the present technology may contain, for example, 60 mg to 90 mg, and preferably 70 mg to 80 mg, of potassium per 100 kcal of energy contained in the composition. The composition of the present technology may contain, for example, 70 mg to 300 mg, and preferably 80 mg to 90 mg, of chlorine per 100 kcal of energy contained in the composition. The composition of the present technology may contain, for example, 30 mg to 900 mg, and preferably 60 mg to 80 mg, of calcium per 100 kcal of energy contained in the composition. The composition of the present technology may contain, for example, 15 mg to 50 mg, and preferably 30 mg to 40 mg, of magnesium per 100 kcal of energy contained in the composition. The composition of the present technology may contain, for example, 30 mg to 90 mg, and preferably 60 mg to 80 mg, of phosphorus per 100 kcal of energy contained in the composition.

[0080] The composition of the present technology may contain, for example, 0.5 mg to 1.5 mg, and preferably 0.7 mg to 1.3 mg, of iron per 100 kcal of energy contained in the composition. The composition of the present technology may contain, for example, 0.03 mg to 0.15 mg of copper per 100 kcal of energy contained in the composition, and preferably 0.07 mg to 0.13 mg of copper per 100 kcal of energy contained in the composition.The composition of the present technology may contain, for example, 0.1 mg to 0.3 mg of manganese per 100 kcal of energy contained in the composition, and preferably 0.15 mg to 0.25 mg of manganese per 100 kcal of energy contained in the composition. The composition of the present technology may contain, for example, 5 μg to 25 μg, and preferably 10 μg to 20 μg, of iodine per 100 kcal of energy contained in the composition. The composition of the present technology may contain, for example, 1 μg to 10 μg, and preferably 2 μg to 6 μg, of selenium per 100 kcal of energy contained in the composition. The composition of the present technology may contain, for example, 1 μg to 10 μg, and preferably 2 μg to 6 μg, of chromium per 100 kcal of energy contained in the composition. The composition of the present technology may contain, for example, 1 μg to 15 μg, and preferably 2 μg to 5 μg, of molybdenum per 100 kcal of energy contained in the composition.

[0081] The composition of the present technology may contain, for example, 30 μg RAE to 120 μg RAE, and preferably 60 μg RAE to 90 μg RAE, of vitamin A per 100 kcal of energy contained in the composition. The composition of the present technology may contain, for example, 5 μg to 15 μg, and preferably 7 μg to 9 μg, of vitamin K per 100 kcal of energy contained in the composition. The composition of the present technology may contain, for example, 0.1 mg to 0.4 mg, and preferably 0.15 mg to 0.2 mg, of vitamin B2 per 100 kcal of energy contained in the composition. The composition of the present technology may contain, for example, 1 mg NE to 10 mg NE, and preferably 4 mg NE to 8 mg NE, of niacin per 100 kcal of energy contained in the composition. The composition of the present technology may contain, for example, 0.1 mg to 1 mg, and preferably 0.4 mg to 0.8 mg, of vitamin B6 per 100 kcal of energy contained in the composition.The composition of the present technology may contain, for example, 0.1 mg to 1 mg, and preferably 0.5 mg to 1 mg, of vitamin B12 per 100 kcal of energy contained in the composition. The composition of the present technology may contain, for example, 20 μg to 100 μg, and preferably 60 μg to 80 μg, of folic acid per 100 kcal of energy contained in the composition. The composition of the present technology may contain, for example, 0.3 mg to 2 mg, and preferably 1 mg to 1.5 mg, of pantothenic acid per 100 kcal of energy contained in the composition. The composition of the present technology may contain, for example, 1 μg to 10 μg, and preferably 3 μg to 7 μg, of biotin per 100 kcal of energy contained in the composition.

[0082] The present technology also provides the following methods and articles. [1] Use of carnitine and vitamin D for the manufacture of a composition for preventing or treating anemia. Use of carnitine and vitamin D for the manufacture of a composition for increasing or preventing a decrease in blood hemoglobin concentration. Use of carnitine and vitamin D for the manufacture of a composition for increasing or preventing a decrease in red blood cell count in blood. [2] Carnitine and Vitamin D for the prevention or treatment of anemia. Carnitine and vitamin D to increase or prevent a drop in hemoglobin levels in the blood. Carnitine and Vitamin D to increase or prevent a drop in red blood cell count. [3] 1. A method for preventing or treating anemia comprising administering carnitine and vitamin D. A method for increasing or preventing a decrease in blood hemoglobin concentration, comprising administering carnitine and vitamin D. A method for increasing or preventing a decrease in red blood cell count, comprising administering carnitine and vitamin D.

[0083] The present technology will be described in more detail below with reference to examples, but the present technology is not limited to these examples. EXAMPLES

[0084] 1. Preparation of Test Compositions Test compositions 1 and 2 having the nutritional compositions shown in Table 1 below were prepared.

[0085] [Table 1]

[0086] Test composition 1 was prepared by mixing water, dextrin, resistant dextrin, vegetable oil, lactulose, refined fish oil, dry yeast, sodium caseinate, pH adjuster, cellulose, emulsifier, carrageenan, vitamin E, flavoring, and sweetener, as well as a mineral mixture and a vitamin mixture.

[0087] Test composition 2 was prepared in the same manner as test composition 1, except that it further contained carnitine (Carnipure crystalline powder, Lonza Japan Co., Ltd.) and increased amounts of vitamin D (vitamin D3 oil, Kanematsu Shintoa Foods Co., Ltd.) and zinc (zinc gluconate, Tomita Pharmaceutical Co., Ltd.).

[0088] 2. Administration of Test Composition Test composition 1 was administered to six tube-fed diabetic patients via a gastrostomy tube for more than three months. The administration schedule and dosage for each patient were as shown in Table 2 below. Test composition 2 was then administered for three months using the same administration method, except that the composition administered was changed from test composition 1 to test composition 2.

[0089] [Table 2]

[0090] As shown in Table 2, each patient was provided with 800 kcal to 1200 kcal of energy by Test Composition 1 or 2. Also, as shown in Table 2, each test composition was administered three to four times a day. The amount of each dose was 200 ml to 400 ml.

[0091] The average daily doses of carnitine, vitamin D, and zinc administered to the six patients using test composition 1 or 2 are shown in Table 3 below. The intakes of nutrients and energy other than those shown in Table 3 were constant during the study period.

[0092] [Table 3]

[0093] 3.Analysis method Before changing from Test Composition 1 to Test Composition 2, and 1 month, 2 months, and 3 months after changing to Test Composition 2, blood samples were taken from each patient, and blood carnitine concentration, vitamin D concentration (25(OH)D value), zinc concentration, hemoglobin concentration, and red blood cell count were measured. These measurements were performed by SRL Co., Ltd. Blood carnitine concentration (total carnitine value and free carnitine value) was measured by the enzyme cycling method. 25(OH)D value was measured by the CLEIA method (chemiluminescence enzyme immunoassay). Zinc concentration was measured by colorimetric method. Hemoglobin concentration was measured by the SLS-hemoglobin method. Red blood cell count was measured by the sheath flow DC (direct current) detection method. Hematocrit value was measured by the red blood cell pulse peak value detection method.

[0094] The average values ​​of the measurements of the six patients were calculated before the change, and one month, two months, and three months after the change. A paired t-test was used to test for significant differences between before and after the change, with a risk rate of 5% or less considered significant. Since the hemoglobin concentration and hematocrit values ​​showed a log-normal distribution, statistical processing was performed using logarithmic transformed values ​​according to the usual method, and the average values ​​were shown as geometric means.

[0095] 4. Results and Discussion The results of the analysis in 3 above are shown in Table 4 below and Figure 1.

[0096] [Table 4]

[0097] As shown in Table 4 and Figure 1, the free carnitine concentration and the total carnitine concentration significantly increased one month after changing from Test Composition 1 to Test Composition 2. Furthermore, this increase was maintained at two and three months after the change.

[0098] Regarding 25(OH) values, although there was no data available before the change, it was confirmed that the values ​​had increased significantly after two and three months compared to after one month.

[0099] No significant increase in zinc concentration was observed before the change or 1 to 3 months after the change.

[0100] It can be seen that the blood red blood cell count gradually increased after the change, and the increase after 3 months was significant.

[0101] It can also be seen that blood hemoglobin levels gradually increased after the change, and the increase after 3 months was significant.

[0102] It can also be seen that blood hematocrit levels gradually increased after the change, and the increase after 3 months was significant.

[0103] From the above results, it can be seen that the number of red blood cells in the blood, the hemoglobin concentration in the blood, and the hematocrit value increased by changing from Test Composition 1 to Test Composition 2. The degree of increase was already apparent one month after the change, and was significantly increased three months after the change. Furthermore, it was found that Test Composition 2 can increase the number of red blood cells in blood, the hemoglobin concentration, and the hematocrit value, and therefore can also be used for the prevention or treatment of anemia.

[0104] Test composition 1 and test composition 2 have differences in that they contain carnitine, vitamin D concentration, and zinc concentration. Therefore, it can be seen that carnitine, vitamin D, and zinc contribute to the increase of blood red blood cell count, blood hemoglobin concentration, and hematocrit value. It can also be seen that the combination of these three components is useful for the prevention or treatment of anemia.

[0105] Carnitine and vitamin D blood concentrations increased with the change from test composition 1 to test composition 2. Meanwhile, zinc blood concentrations did not increase with the change from test composition 1 to test composition 2. Therefore, it is found that among carnitine, vitamin D, and zinc, carnitine and vitamin D especially contribute to the increase in blood red blood cell count, blood hemoglobin concentration, and hematocrit value. It is also found that the combination of carnitine and vitamin D is particularly useful for the prevention or treatment of anemia.

[0106] For Test Composition 2, the average daily dose of carnitine was 157.5±22.8 mg, as shown in Table 3 above. The minimum average dose was 120 mg / day for Patient 3. The maximum average dose was 180 mg / day for Patient 1. Therefore, to increase or prevent a decrease in blood red blood cell count and / or blood hemoglobin concentration, or to prevent or treat anemia, carnitine is administered in a daily dose of, for example, 10 mg or more, preferably 30 mg or more, more preferably 50 mg or more, and even more preferably 100 mg or more. Also, for increasing or preventing a decrease in blood red blood cell count and / or blood hemoglobin concentration, or for preventing or treating anemia, carnitine may be administered, for example, at a daily dose of 500 mg or less, preferably 400 mg or less, more preferably 300 mg or less, and even more preferably 200 mg or less.

[0107] For Test Composition 1, the average daily dose of vitamin D was 5.3±0.8 μg / day, as shown in Table 3 above. For Test Composition 1, the minimum average dose was 4 μg / day for Patient 3. For Test Composition 1, the maximum average dose was 6 μg / day for Patient 1. On the other hand, the average daily dose of vitamin D in Test Composition 2 was 10.5±1.5 μg / day, as shown in Table 3 above. For Test Composition 2, the minimum average dose was 8 μg / day for Patient 3. For Test Composition 2, the maximum average dose was 12 μg / day for Patient 1. Therefore, to increase or prevent a decrease in blood red blood cell count and / or blood hemoglobin concentration, or to prevent or treat anemia, vitamin D is administered at a daily dose of, for example, 6 μg or more, preferably 7 μg or more.

[0108] For Test Composition 1, the mean daily dose of zinc was 9.5±1.4 mg / day, as shown in Table 3 above. For Test Composition 1, the minimum mean dose was 7.2 mg / day for Patient 3. For Test Composition 1, the maximum mean dose was 10.8 mg / day for Patient 1. Meanwhile, the average daily dose of zinc in Test Composition 2 was 12.6±1.8 mg / day, as shown in Table 3. For Test Composition 2, the minimum average dose was 9.6 mg / day for Patient 3. For Test Composition 2, the maximum average dose was 14.4 mg / day for Patient 1. Therefore, to increase or prevent a decrease in blood red blood cell count and / or blood hemoglobin concentration, or to prevent or treat anemia, zinc is administered at a daily dose of, for example, 8 mg or more, preferably 9 mg or more, more preferably 10 mg or more, and even more preferably 11 mg or more.

Claims

1. A composition for preventing or treating anemia in diabetic patients, comprising carnitine and vitamin D (excluding those administered to chronic kidney disease patients using ESAs).

2. A composition for preventing an increase or decrease in blood hemoglobin concentration in diabetic patients, comprising carnitine and vitamin D (excluding those administered to chronic kidney disease patients using ESAs).

3. A composition for increasing or preventing a decrease in red blood cell count in diabetic patients, comprising carnitine and vitamin D (excluding those administered to chronic kidney disease patients using ESAs).

4. The composition according to any one of claims 1 to 3, wherein the composition is administered so that the daily dose of the carnitine is 500 mg or less.

5. The composition according to any one of claims 1 to 4, wherein the composition is administered so that the daily dose of the carnitine is 10 mg or more.

6. The composition according to any one of claims 1 to 4, wherein the composition is administered so that the daily dose of the carnitine is 100 mg or more.

7. The composition according to any one of claims 1 to 6, wherein the composition is administered so that the daily dose of vitamin D is 3 µg or more.

8. The composition of any one of claims 1 to 7, wherein the composition further comprises zinc.

9. 9. The composition of claim 8, wherein the composition is administered to provide a daily dosage of the zinc of 5 mg or more.

10. The composition according to any one of claims 1 to 9, wherein the composition is administered to a tube-fed patient.

11. The composition according to any one of claims 1 to 10, wherein the composition is a food or drink composition.

12. The composition according to any one of claims 1 to 10, wherein the composition is a pharmaceutical composition.

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