JP7627100B2 - Composition for preventing or treating anemia, composition for preventing an increase or decrease in blood hemoglobin concentration, and composition for preventing an increase or decrease in blood red blood cell count - Google Patents

Description

This 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.

Anemia occurs when the hemoglobin concentration in the blood or the number of red blood cells decreases. Hemoglobin and red blood cells that contain hemoglobin carry oxygen to various parts of the body. Therefore, a decrease in hemoglobin concentration or red blood cell count causes various parts of the body to become oxygen-deprived, resulting in the symptoms of anemia. Examples of symptoms of anemia include lightheadedness, shortness of breath, dizziness, unsteadiness, palpitations, fatigue, and pale complexion.

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, the following Patent Document 1 discloses a "composition for preventing or treating anemia, the active ingredient of which is bacteria belonging to the genus Bifidobacterium."

International Publication No. 2011/114916

Anemia occurs in subjects of all 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.

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

In light of the above, the present technology aims to provide a new method for dealing with anemia. The present technology also aims to provide a new method for increasing the hemoglobin concentration or red blood cell count in the blood.

The inventors have found that certain compositions can address anemia. The inventors have also found that certain compositions can increase the hemoglobin concentration or red blood cell count in the blood.

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 according to 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 according to 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 described in [6], wherein the composition is administered so that the daily dosage of zinc is 5 mg or more.
[8] The composition according to any one of [1] to [7], wherein the composition is administered to a tube-fed patient.
[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.

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.

1 is a graph showing the analysis results regarding blood components.

The following describes a preferred embodiment of the present technology. However, the present technology is not limited to the following preferred embodiment, and can be freely modified within the scope of the present technology.

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. Furthermore, 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.

The carnitine and vitamin D contained in the composition of the present technology are both 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.

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 blood hemoglobin concentration or red blood cell count.

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

In this specification, "prevention of anemia" may include preventing the occurrence of anemia, reducing the risk of the occurrence of anemia, reducing the likelihood of the occurrence of anemia, preventing the onset of at least one symptom of anemia, reducing the risk of the onset of at least one symptom of anemia, and reducing the likelihood of the onset of at least one symptom of anemia, and may mean one or more of these.

In this specification, "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.

In this specification, "increasing blood hemoglobin concentration" may literally mean increasing blood hemoglobin concentration. In this 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.

Similarly, in this 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 this 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.

The composition of this technology is described in more detail below.

(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 carnitine tartrate and fumarate.

Carnitine exerts, for example, the effect of promoting ATP production, the effect of maintaining the free CoA pool, the effect of an endogenous detoxifier (e.g., acyl-CoA excretion), the effect of enhancing the expression of antioxidant enzymes, the effect of inhibiting apoptosis, the effect of antioxidants, the effect of anti-inflammatory effects, the effect of stabilizing biomembranes, and the effect of inhibiting fibrosis. Since the composition of the present technology contains carnitine, it may be used to exert any 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.

The composition of the present technology may be administered to a subject such 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 more than 500 mg. The carnitine contained in the composition of the present technology may be administered at a lower dosage compared to such a dosage. Even with such a low daily dosage of carnitine, the composition of the present technology is useful for preventing or treating anemia, or for increasing or preventing a decrease in hemoglobin concentration or red blood cell count in blood.

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 amount 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 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.

(2) Vitamin D
The compositions of the present technology include 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.

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. 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.

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, and may be, 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.

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, when the composition of the present technology is in the liquid, paste, jelly, powder, or solid form.

(3) Zinc The composition of the present technology may further contain zinc in addition to carnitine and vitamin D. The zinc may be included in the composition of the present technology, for example, as a zinc-containing compound or a zinc-containing microbial material. The zinc-containing compound may include organic zinc or inorganic zinc. Examples of the organic zinc include zinc gluconate and zinc amino acid. Examples of the inorganic zinc include zinc sulfate, zinc oxide, zinc acetate, zinc tartrate, and zinc lactate. The zinc-containing microbial material may 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.

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 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.

The zinc content 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 energy of the composition of the present technology. The zinc content 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 energy 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.

(4) Other Components The composition of the present technology may further include other components. Examples of the other components 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 components.

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.

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.

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 the energy content 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 the energy content of the composition.
The content of the resistant dextrin per 100 kcal of the energy amount 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 amount of the composition of the present technology 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.

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.

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, particularly 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.

The content of vitamin B1 per 100 kcal of the energy content of the composition of the present technology may be, for example, 0.1 mg or more, 0.2 mg or more, or 0.3 mg or more. Also, the content of vitamin B1 per 100 kcal of the energy content of the composition may be, for example, 1 mg or less, 0.9 mg or less, or 0.8 mg or less.
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 the 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 the 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.

The composition of the present technology may further contain a protein. The protein is not particularly limited as long as it is used in foods, 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. Examples of milk proteins that can be used include casein hydrolysates, caseinates such as sodium caseinate and calcium caseinate, milk protein concentrate (MPC), whey protein concentrate (WPC), and whey protein hydrolysates.

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. The upper limit of the daily dose may be, for example, 80 g or less, 70 g or less, or 60 g or less.

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.

The composition of the present technology may further contain a lipid. The lipid may be any oil or fat used in food, such as vegetable oils such as soybean oil, rapeseed oil, corn oil, and the like, and animal oils such as fish oil, without any particular restrictions. Among them, vegetable oils are preferably used, and soybean oil is more preferably used. The lipid may also contain a medium-chain fatty acid triglyceride. It may also contain EPA and/or DHA.

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.
In addition, the composition of the present technology may be administered to a subject so that the daily dose of the 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.
In addition, 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.

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. Also, the lipid content 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. The EPA content 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 the DHA may be, for example, 5 mg or more, 10 mg or more, or 12 mg or more per 100 kcal of energy of the composition. The content of the DHA may be, for example, 50 mg or less, 38 mg or less, or 25 mg 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.

The composition of the present technology may further include 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.

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, and in particular, the total daily dose is 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.

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. Also, the total content of the amino acids 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.

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

The composition of the present technology may be administered to a subject so that the daily dose of the carbohydrate is 80 g or more, and in particular so that the daily dose is 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.

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. 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.

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.

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.

(5) Physical Properties of the Composition The composition of the present technology may be in the form of a liquid, a paste, a gel (jelly), a powder, or a solid, and is preferably in the form of a liquid or gel, and more preferably in the form of a liquid.

The composition of the present technology preferably has fluidity. For example, it may be a fluid liquid or gel composition. For example, the composition of the present technology may be a liquid food.

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

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.

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.

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.

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.

In one embodiment of the present technology, the energy content per 1 ml of the composition of the present technology may 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 may 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 may 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.

(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, confectionery, or beverages.

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 anemic symptoms, or increase in blood hemoglobin concentration or blood red blood cell count. 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 health by increasing hemoglobin concentration," "helpful for maintaining health 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 uses of the composition of the present technology, and any expression that can recall and/or infer the above-mentioned uses 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.

In addition, it is preferable that the "labeling" be done in a manner that allows consumers to directly recognize the above-mentioned uses. Specifically, this includes the acts of transferring, delivering, displaying for transfer or delivery, 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 via electromagnetic means (Internet, etc.), etc.

On the other hand, it is preferable that the content of the labeling be approved by the government or the like (for example, a labeling approved based on various systems established by the government and made in a manner based on such approval). It is also preferable that such content of the labeling be affixed to promotional materials at the point of sale such as packaging, containers, catalogs, pamphlets, and POP, as well as other documents, etc.

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, such as labeling approved under the system related to food for specified health uses, nutrient functional food, or functional food labeling, or similar systems, 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 that reduces the risk of disease, labeling of functionality based on scientific evidence, etc., can be mentioned. 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 Purposes Provided in the Health Promotion Act (Cabinet Office Ordinance No. 57 of August 31, 2009) are typical examples.

(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.

When the composition according to the present technology is used as a pharmaceutical composition, the pharmaceutical composition may be administered either orally or parenterally, and can be formulated into a desired dosage form depending on the administration method. For example, in the case of oral administration, the composition can 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 can be administered, for example, via a gastrostomy tube.

In addition, when preparing a formulation, the pharmaceutical composition according to the present technology can contain ingredients that are usually 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, the pharmaceutical composition according to the present technology can also contain ingredients that have known or future discoverable effects on preventing, improving, and/or treating anemia or symptoms thereof.
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.

(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 may be formed as a final product.

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

The manufacturing method may further include a filling 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.

(9) Method of using the composition The subject to which the composition of the present technology is administered 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 to which the composition of the present technology is administered 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 increasing or preventing a decrease in hemoglobin concentration and/or red blood cell count in the blood of such elderly people.

The composition of the present technology may be used, for example, for administration to a human in whom prevention or treatment of anemia is desired, or for administration to a human in whom an increase in blood hemoglobin concentration or blood red blood cell count is desired. 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.

The compositions of the present technology may be taken, for example, orally or by tube. In the latter case, the compositions of the present technology are administered to a human, for example, via a gastrostomy tube. That is, the compositions of the present technology may be administered to a tube-fed patient. For use in administration to tube-fed patients, the compositions of the present technology may, for example, have a liquid form.

In one embodiment of the present technology, the composition of the present technology may be administered such that the composition of the present technology provides a subject with 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. For example, the composition of the present technology may provide a subject with an amount of energy of 200 kcal to 500 kcal per administration, which may be administered 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. There is no upper limit to the administration period of the composition of the present technology, and it may be, for example, three years or less, two years or less, or one year or less, but it may be administered without a set end time for the administration period.

(10) Examples of Nutritional Composition of Composition Examples of nutritional composition per 100 kcal of the composition of the present technology are described below.

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.

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.

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, 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, 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, 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.

The composition of the present technology may contain, for example, 30 μg RAE to 120 μg RAE of vitamin A per 100 kcal of energy of the composition, and preferably 60 μg RAE to 90 μg RAE.
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.

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 for increasing or preventing a decrease in blood hemoglobin levels.
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.

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

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

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.

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.).

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 administered composition was changed from Test Composition 1 to Test Composition 2.

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.

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 remained constant during the study period.

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 colorimetry. 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.

The average values of the measurements of 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 significance between the values before and after the change, with a risk level of 5% or less considered significant. As the hemoglobin concentration and hematocrit values showed a log-normal distribution, statistical processing was performed using log-converted values in the usual manner, and the average values were shown as geometric means.

4. Results and Discussion The results of the analysis in 3 above are shown in Table 4 and FIG.

As shown in Table 4 and Figure 1, the free carnitine concentration and 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.

Although there is no data on 25(OH) levels before the change, it was confirmed that there was a significant increase after two and three months compared to after one month.

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

It can be seen that the number of red blood cells in the blood gradually increased after the change. Furthermore, the increase after three months was significant.

It can also be seen that blood hemoglobin concentration gradually increased after the change. Furthermore, the increase after three months was significant.

It can also be seen that blood hematocrit levels gradually increased after the change. Furthermore, the increase after three months was significant.

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 can be seen 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 to prevent or treat anemia.

Test composition 1 and test composition 2 differ in that they contain carnitine, have different vitamin D concentrations, and have different zinc concentrations. Therefore, it is found that carnitine, vitamin D, and zinc contribute to an increase in the number of red blood cells in the blood, the hemoglobin concentration in the blood, and the hematocrit value. It is also found that the combination of these three components is useful for preventing or treating anemia.

The blood concentrations of carnitine and vitamin D increased with the change from Test Composition 1 to Test Composition 2. On the other hand, the blood concentration of zinc did not increase with the change from Test Composition 1 to Test Composition 2. Therefore, it can be seen that, among carnitine, vitamin D, and zinc, carnitine and vitamin D in particular contribute to the increase in blood red blood cell count, blood hemoglobin concentration, and hematocrit value. It can also be seen that the combination of carnitine and vitamin D is particularly useful for the prevention or treatment of anemia.

For Test Composition 2, the mean daily dose of carnitine was 157.5±22.8 mg, as shown in Table 3 above. The minimum mean dose was 120 mg/day for Patient 3, and the maximum mean 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, in an amount of not more than 500 mg, preferably not more than 400 mg, more preferably not more than 300 mg, and even more preferably not more than 200 mg per day.

For Test Composition 1, the mean daily dose of Vitamin D was 5.3±0.8 μg/day, as shown in Table 3 above. For Test Composition 1, the minimum mean dose was 4 μg/day for Patient 3. For Test Composition 1, the maximum mean 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.

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 dosage 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 (12)

A composition for preventing or treating anemia in diabetic patients (excluding those administered to patients with chronic kidney disease), comprising carnitine and vitamin D. A composition for preventing an increase or decrease in blood hemoglobin concentration in diabetic patients , comprising carnitine and vitamin D (excluding those administered to patients with chronic kidney disease). 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 patients with chronic kidney disease). 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. 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. 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. 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. The composition according to any one of claims 1 to 7, further comprising zinc. The composition of claim 8, wherein the composition is administered to provide a daily dose of the zinc of 5 mg or more. The composition according to any one of claims 1 to 9, wherein the composition is administered to a tube-fed patient. The composition according to any one of claims 1 to 10, wherein the composition is a food or drink composition. The composition according to any one of claims 1 to 10, wherein the composition is a pharmaceutical composition.