Agent for reducing anemia risk

Abstract

The present invention provides a medicine or a food / drink for suppressing the onset of anemia. Specifically, the present invention provides an agent for reducing the risk of anemia onset containing Lacticaseibacillus paracasei YIT9029 (FERM BP-1366) as an active ingredient.

Description

Anemia risk reducer

[0001] The present disclosure relates to anemia risk-reducing agents.

[0002] Anemia refers to a condition in which the amount of hemoglobin in the blood is low. The standard for anemia defined by the World Health Organization (WHO) is a hemoglobin level of less than 130 g / L for adult men and less than 120 g / L for adult women. Causes of anemia include iron and vitamin B 12 Possible causes of anemia include insufficient red blood cell production due to a lack of nutrients necessary for red blood cell production, such as folic acid, excessive bleeding, decreased bone marrow function, and excessive destruction of red blood cells. Symptoms of anemia include fatigue, shortness of breath, paleness, and headache, and depending on the type and severity of the symptoms, they can cause significant disruption to daily life. Therefore, it is important to prevent anemia on a daily basis.

[0003] Patent Document 1 discloses a composition for treating iron deficiency anemia, which contains fermented milk using lactic acid bacteria belonging to Lactobacillus acidophilus and iron salt as active ingredients. Patent Document 2 discloses a composition for improving renal anemia, which contains lactic acid bacteria belonging to Lactobacillus amylovorus and / or a processed product thereof as active ingredients. On the other hand, Non-Patent Document 1 describes that lactic acid bacteria belonging to the genus Lactobacillus bulgaricus are not effective against iron deficiency anemia. Thus, the effect of lactic acid bacteria on anemia varies greatly depending on the species and strain. Furthermore, the lactic acid bacteria in Patent Documents 1 and 2 are used to treat anemia that has already developed, and it is not known how they affect users before the onset of anemia.

[0004] JP 7-53391 A International Publication No. 2018 / 003899

[0005] G. Schaafsma et al., Neth. Milk Dairy J., Vol. 42, 135-146, 1988

[0006] The present disclosure relates to providing a drug or food or drink for reducing the risk of developing anemia.

[0007] The present inventors have investigated the relationship between the intake of Lacticase Bacillus paracasei YIT 9029 and the incidence of anemia and found that the incidence of anemia in people who habitually take Lacticase Bacillus paracasei YIT 9029 is lower than the incidence of anemia in people who do not habitually take Lacticase Bacillus paracasei YIT 9029, thereby completing the present disclosure.

[0008] That is, the present disclosure provides the following [1] to

[10] . [1] An agent for reducing the risk of developing anemia, comprising Lacticase Bacillus paracasei YIT 9029 (FERM BP-1366) as an active ingredient. [2] The agent for reducing the risk of developing anemia according to [1], which is taken before the onset of anemia. [3] The agent for reducing the risk of developing anemia according to [1] or [2], which is taken three or more times per week. [4] The agent for reducing the risk of developing anemia according to any one of [1] to [3], which is taken continuously for 10 years or more. [5] A food or beverage for reducing the risk of developing anemia, comprising Lacticase Bacillus paracasei YIT 9029 as an active ingredient. [6] The food or beverage for reducing the risk of developing anemia according to [5], which is a fermented food or beverage. [7] A food or beverage composition for reducing the risk of developing anemia, comprising Lacticase Bacillus paracasei YIT 9029 as an active ingredient. [8] Use of Lacticase Bacillus paracasei YIT 9029 for producing an agent for reducing the risk of developing anemia. [9] Use of Lacticase Bacillus paracasei YIT 9029 for reducing the risk of developing anemia.

[10] A method for reducing the risk of developing anemia in a subject, comprising having a subject before the onset of anemia ingest Lacticase Bacillus paracasei YIT 9029.

[0009] According to the present disclosure, the risk of developing anemia can be reduced by taking Lacticase Bacillus paracasei YIT 9029.

[0010] 10 shows the rate of non-onset of anemia measured by the Kaplan-Meier method for a group that took a Lacticase Bacillus paracasei-containing composition less than three times a week and a group that took it three or more times a week for the past 10 years.

[0011] The active ingredient of the anemia risk-reducing agent of the present disclosure is Lacticaseibacillus paracasei YIT 9029 (FERM BP-1366), preferably a live bacterium of Lacticaseibacillus paracasei YIT 9029. The above-mentioned Lacticaseibacillus paracasei YIT 9029 has been internationally deposited as Lactobacillus casei YIT 9029 (FERM BP-1366, date of deposit: May 1, 1981) with the Microbial Research Institute, Agency of Industrial Science and Technology, Ministry of International Trade and Industry, which is the international depository authority of the Budapest Treaty (currently the Patent Organism Depositary Center, National Institute of Technology and Evaluation, Room 120, 2-5-8 Kazusa Kamatari, Kisarazu City, Chiba Prefecture, 292-0818, Japan). In addition, Lacticaseibacillus paracasei was previously classified as Lactobacillus casei, but in recent years the genus Lactobacillus has been reclassified and classified as Lacticaseibacillus paracasei (Zheng et al., A taxonomic note on the genus Lactobacillus: Description of 23 novel genera, emended description of the genus Lactobacillus Beijerinck 1901, and union of Lactobacillaceae and Leuconostocaceae. Int. J. Syst. Evol. Microbiol. 2020 Apr;70(4):2782-2858 DOI 10.1099 / ijsem.0.004107). In this specification, the classification of lactic acid bacteria is described in the new classification based on the above literature.

[0012] The form of use of Lacticase Bacillus paracasei YIT 9029 used in the present disclosure is not particularly limited, and it may be in any form, such as freeze-dried or spray-dried, or may be used as a culture containing the bacterium or a processed bacterial cell product.

[0013] As shown in the Examples below, Lacticase Bacillus paracasei YIT 9029 has the effect of reducing the risk of developing anemia. Therefore, Lacticase Bacillus paracasei YIT 9029 can be used as an agent for reducing the risk of developing anemia and can be used to produce an agent for reducing the risk of developing anemia. That is, Lacticase Bacillus paracasei YIT 9029 can be administered to humans before the onset of anemia to reduce the risk of developing anemia.

[0014] Here, "anemia" refers to a state in which the amount of hemoglobin in the blood is reduced. In the present disclosure, a person is said to be anemic if the hemoglobin amount meets the standard values ​​for anemia defined by the World Health Organization (WHO) (less than 130 g / L for adult men and less than 120 g / L for adult women) and / or if the person has been diagnosed with anemia by a doctor based on a medical interview regarding nonspecific symptoms of anemia (e.g., fatigue, shortness of breath, pallor, headache, etc.).

[0015] Furthermore, "reducing the risk of developing anemia" refers to preventing or delaying the onset of anemia. According to the present disclosure, habitually taking Lacticase Bacillus paracasei YIT 9029 three or more times a week can reduce the risk of developing anemia compared to taking it less than three times a week, making it possible to prevent the onset of anemia.

[0016] The anemia risk-reducing agent of the present disclosure can be administered orally or parenterally, with oral administration being preferred. For administration, the active ingredient, Lacticaseibacillus paracasei YIT 9029, preferably a composition containing live Lacticaseibacillus paracasei YIT 9029 bacteria, can be mixed with a solid or liquid non-toxic pharmaceutical carrier suitable for oral or rectal administration, and administered in the form of a conventional pharmaceutical formulation. Examples of such formulations include solids such as tablets, granules, powders, and capsules; liquids such as solutions, suspensions, and emulsions; and lyophilized preparations. These formulations can be prepared using conventional pharmaceutical techniques. Examples of such non-toxic pharmaceutical carriers include glucose, lactose, sucrose, starch, mannitol, dextrin, fatty acid glycerides, polyethylene glycol, hydroxyethyl starch, ethylene glycol, polyoxyethylene sorbitan fatty acid esters, amino acids, gelatin, albumin, water, and physiological saline. If necessary, conventional additives such as stabilizers, wetting agents, emulsifiers, binders, tonicity agents, excipients, etc. may also be added appropriately.

[0017] Commercially available pharmaceutical preparations may be used, and a pharmaceutical preparation containing live bacteria of Lacticase Bacillus paracasei YIT 9029 manufactured by Yakult Honsha Co., Ltd., preferably Lacticase Bacillus paracasei YIT 9029, can be preferably used. Specific examples thereof include, but are not limited to, "Yakult BL Intestinal Regulatory Medicine."

[0018] The anemia risk-reducing agent of the present disclosure can be used not only in the form of the above-mentioned preparations, but also as a food or beverage containing live Lacticaseibacillus paracasei YIT 9029, preferably live Lacticaseibacillus paracasei YIT 9029 bacteria. That is, the anemia risk-reducing agent of the present disclosure can be used as a food or beverage for reducing the risk of anemia, containing Lacticaseibacillus paracasei YIT 9029 as an active ingredient. The anemia risk-reducing agent of the present disclosure can also be used as a food or beverage composition for reducing the risk of anemia, containing Lacticaseibacillus paracasei YIT 9029 as an active ingredient. When live Lacticaseibacillus paracasei YIT 9029, preferably live Lacticaseibacillus paracasei YIT 9029 bacteria, are incorporated into a food or beverage, they may be incorporated as is or together with various nutritional components. The composition of the present disclosure can be used as a health food or food ingredient useful for suppressing the onset of anemia, and these foods and beverages or their containers may be labeled as having the above-mentioned effect. Specifically, when Lacticase Bacillus paracasei YIT 9029, preferably live Lacticase Bacillus paracasei YIT 9029 bacteria, are incorporated into foods and beverages, additives usable for foods and beverages may be appropriately used and the composition may be formed into an edible form, such as granules, tablets, capsules, or paste, using conventional means. The composition may also be added to various foods, such as processed meat foods such as ham and sausage, processed seafood foods such as kamaboko and chikuwa, bread, confectionery, butter, and powdered milk, or to beverages such as water, fruit juice, milk, soft drinks, and tea drinks.

[0019] Such food and drink products may be commercially available as food products, and preferably include foods containing live bacteria of Lacticase Bacillus paracasei YIT 9029 manufactured by Yakult Honsha Co., Ltd. Specific examples include, but are not limited to, "Synprotec" and "Multi-Probiotic Supplement."

[0020] Furthermore, suitable foods and beverages include fermented milk foods and beverages, such as fermented soy milk, fermented fruit juice, and fermented vegetable juice, containing Lacticase Bacillus paracasei YIT 9029, preferably containing live Lacticase Bacillus paracasei YIT 9029 bacteria. Fermented milk foods and beverages are particularly preferred. Fermented milk foods and beverages can be produced according to conventional methods. For example, when producing fermented milk, Lacticase Bacillus paracasei YIT 9029 is inoculated and cultured in a sterilized milk medium, either alone or together with other microorganisms, and the resulting mixture is homogenized to obtain a fermented milk base. A separately prepared syrup solution is then added and mixed, homogenized using a homogenizer, or the like, and flavors are added to produce the final product. The fermented milk foods and beverages obtained in this manner can be in any form, such as plain, soft, or fruit-flavored, solid, or liquid, without syrup (sweetener).

[0021] Such fermented milk foods and drinks can contain optional ingredients such as sweeteners such as syrup, emulsifiers, thickeners (stabilizers), various vitamins, etc. Examples of syrup include sugars such as glucose, sucrose, fructose, high-fructose corn syrup, high-fructose corn syrup, palatinose, trehalose, lactose, xylose, maltose, honey, and molasses, sugar alcohols such as sorbitol, xylitol, erythritol, lactitol, palatinit, reduced starch syrup, and reduced maltose syrup, and high-intensity sweeteners such as aspartame, thaumatin, sucralose, acesulfame K, and stevia. Fermented milk foods and drinks may also contain emulsifiers such as sucrose fatty acid esters, glycerin fatty acid esters, polyglycerin fatty acid esters, sorbitan fatty acid esters, and lecithin, and thickeners (stabilizers) such as agar, gelatin, carrageenan, guar gum, xanthan gum, pectin, locust bean gum, gellan gum, carboxymethylcellulose, soybean polysaccharides, and propylene glycol alginate. Other ingredients that can be added include vitamins such as vitamin A, B vitamins, vitamin C, and vitamin E; minerals such as calcium, magnesium, zinc, iron, and manganese; acidulants such as citric acid, lactic acid, acetic acid, malic acid, tartaric acid, and gluconic acid; milk fats such as cream, butter, and sour cream; flavors such as yogurt, berry, orange, quince, perilla, citrus, apple, mint, grape, apricot, pear, custard cream, peach, melon, banana, tropical, herbal, black tea, and coffee; herbal extracts; and brown sugar extracts.

[0022] Alternatively, commercially available fermented milk foods and beverages may be used, and fermented milk foods and beverages containing live Lacticase Bacillus paracasei YIT 9029 bacteria manufactured by Yakult Honsha Co., Ltd. are suitable. Specific examples include, but are not limited to, Yakult products such as "New Yakult," "Yakult 400," "Yakult 1000," and "Y1000," as well as "Joa" and "Sofur." ​​Products containing a high number of live Lacticase Bacillus paracasei bacteria are particularly preferred, as they are expected to be more effective. All Yakult products are lactic acid bacteria beverages containing a high number of live Lacticase Bacillus paracasei YIT 9029 bacteria. The above-mentioned products contain approximately 1 x 10 Lacticase Bacillus paracasei YIT 9029 bacteria. 9 cfu ~ 1 x 10 11 Contains cfu / unit.

[0023] There is no strict limit to the intake amount of Lacticase Bacillus paracasei YIT 9029, which is the active ingredient of the present disclosure. However, the preferred intake amount is 1 x 10 viable cell count of Lacticase Bacillus paracasei YIT 9029 per day for an adult (60 kg). 5 cfu ~ 1 x 10 13 cfu, particularly 1 x 10 8 cfu ~ 2 x 10 12 cfu is preferred. From the viewpoint of effectively reducing the risk of developing anemia, it is preferable to take Lacticase Bacillus paracasei YIT 9029 frequently, particularly preferably three or more times per week. Furthermore, it is preferable to take Lacticase Bacillus paracasei YIT 9029 for a long period of time, particularly preferably 10 years or more.

[0024] The subjects for taking the supplement include humans who need or wish to reduce the risk of developing anemia, with middle-aged and elderly people (e.g., those aged 55 or older) being more preferred, and men being more preferred.

[0025] The agent for reducing the risk of developing anemia of the present disclosure may contain other active ingredients as long as the effects of the invention are not impaired.

[0026] Ingestion of the anemia risk-reducing agent of the present disclosure before the onset of anemia suppresses the onset of anemia and can prevent the onset of anemia. Furthermore, even after the onset of anemia, the recurrence rate of anemia can be reduced by ingesting the anemia risk-reducing agent of the present disclosure after treating the anemia by supplementing deficient nutrients, administering medication, stopping bleeding, transfusion, surgery, etc.

[0027] The present disclosure also relates to a method for reducing the risk of developing anemia in a subject, comprising administering Lacticase Bacillus paracasei YIT 9029 to a subject before the onset of anemia. By using this method, the onset of anemia can be suppressed and prevented if it is administered before the onset of anemia. Furthermore, even after the onset of anemia, the recurrence rate of anemia can be reduced after treating the anemia by supplementing deficient nutrients, administering medication, hemostasis, transfusion, surgery, or the like.

[0028] The present disclosure will now be described in more detail with reference to examples, but the present disclosure is not limited to these examples in any way.

[0029] Example 1. Methods (1) Study Overview A retrospective epidemiological study was conducted using interviews and self-administered questionnaires on elderly people aged 65 years or older who have physical functions that do not interfere with daily life and who have agreed to and signed the study details, and data was obtained on the characteristics of the subjects (physical measurements, smoking habits, drinking habits, nutritional intake), medical history, and general intake status of Lacticaseibacillus paracasei-containing compositions and lactic acid bacteria-containing compositions.

[0030] (2) Medical History: Subjects were interviewed to determine whether they had been diagnosed with anemia that met the following criteria and their age at the time. Criteria: Meeting the hemoglobin level standard for anemia defined by the WHO (less than 130 g / L for adult men and less than 120 g / L for adult women) and / or a doctor's diagnosis of anemia based on a medical interview regarding nonspecific symptoms of anemia (e.g., fatigue, shortness of breath, pallor, headache, etc.).

[0031] (3) Intake of Lacticase Bacillus paracasei-containing compositions "Yakult," "Yakult LT," "Yakult 300V," "Yakult Ace," "Yakult 80Ace," "New Yakult," "New Yakult Calorie Half," "Yakult 400," "Yakult 400LT," "Yakult 1000," "Y1000" (collectively referred to as "Yakult products," manufactured by Yakult Honsha), "Joie," "Sofur," and "Pretio" (manufactured by Yakult Honsha). The above products (Yakult products, Joie, Sofur, and Pretio) are all foods and beverages containing live Lacticase Bacillus paracasei YIT 9029 bacteria. The subjects were surveyed about their intake (frequency of intake) of the above products over the past 10 years.

[0032] (4) Intake of lactic acid bacteria-containing compositions The subjects were surveyed over the past 10 years to determine their intake (frequency of intake) of various lactic acid bacteria-containing foods and beverages, including the Lactic acid bacteria-containing composition (collectively referred to as lactic acid bacteria-containing compositions).

[0033] (5) Subjects of analysis Of the 1,800 survey participants, those who did not report the age at which anemia developed, those who could not recall the frequency of intake of Lacticaseibacillus paracasei-containing composition and / or lactic acid bacteria-containing composition, and those who had developed anemia more than 10 years ago were excluded, and 1,539 subjects were analyzed (715 men, 824 women, mean age 73.4±6.5 years).

[0034] (6) Method for analyzing the relationship between intake status of Lacticase Bacillus paracasei-containing composition over the past 10 years and the risk of developing anemia The subjects were divided into two groups: those who had taken Lacticase Bacillus paracasei-containing composition less than three times a week over the past 10 years (hereinafter referred to as the intake group less than three times a week) and those who had taken it three or more times a week (hereinafter referred to as the intake group three or more times a week). The incidence of anemia over the past 10 years in the intake group less than three times a week and the intake group three or more times a week was calculated as χ 2The results were compared using a log-rank test (Table 1). Furthermore, for the group consuming less than three times a week and the group consuming three or more times a week, anemia-free rate curve was created using the Kaplan-Meier method, and a Log-Rank test was used to examine whether there was a significant difference in the trends in the anemia-free rate between the two groups (Figure 1). Furthermore, a Cox proportional hazards regression analysis was performed to examine the relationship between intake and anemia risk, adjusting for differences in age, sex, drinking habits, and smoking habits between the group consuming less than three times a week and the group consuming three or more times a week (confounding factors: age, sex, BMI, smoking habits, and drinking habits) (Table 2).

[0035] (7) Method for analyzing the relationship between intake of lactic acid bacteria-containing compositions over the past 10 years and the risk of developing anemia Similarly, the incidence of anemia (Table 1) and the risk of developing anemia adjusted for differences in age, sex, drinking habits, and smoking habits (Table 2) were compared between those who had consumed lactic acid bacteria-containing compositions less than three times a week over the past 10 years and those who had consumed them three or more times a week.

[0036] (8) Comparison of subject backgrounds For some subjects whose blood data and nutritional intake status were available, the blood parameters and nutritional intake status at the time of the survey were compared between the group consuming less than three times a week and the group consuming three or more times a week using analysis of covariance with age and sex as covariates.

[0037] 2. Results (1) Relationship between intake of Lacticase Bacillus paracasei-containing composition over the past 10 years and risk of anemia. Of the 1,539 subjects, 1,285 consumed Lacticase Bacillus paracasei-containing composition less than three times per week, of which 55 (4.3%) developed anemia. 254 consumed Lacticase Bacillus paracasei-containing composition three or more times per week, of which 3 (1.2%) developed anemia (P = 0.018, Table 1). Furthermore, a comparison of the anemia-free rate curves using the Kaplan-Meier method showed that the group consuming Lacticase Bacillus paracasei three or more times per week had a significantly higher anemia-free rate over the 10-year period compared with the group consuming Lacticase Bacillus paracasei less than three times per week (P = 0.018, Figure 1). The group consuming Lacticase Bacillus paracasei more than three times per week had a significantly lower risk of anemia compared with the group consuming Lacticase Bacillus paracasei less than three times per week (P = 0.030, Table 2). In particular, among men, there were no anemia-free rates in the group consuming Lacticase Bacillus paracasei more than three times per week. Furthermore, a similar analysis was performed on lactic acid bacteria-containing compositions, and no significant differences were observed in the incidence of anemia (Table 1) or the risk of developing anemia (Table 2) between the group that had taken lactic acid bacteria-containing compositions three or more times a week for the past 10 years and the group that had taken lactic acid bacteria-containing compositions three or more times a week for the past 10 years (P = 0.103 and P = 0.109, respectively).

[0038]

[0039]

[0040] (2) Comparison of Subject Backgrounds When comparing the nutritional intake status of subjects in the group consuming iron less than three times a week with the group consuming iron three or more times a week, iron intake was significantly higher in the group consuming iron three or more times a week (8.6 ± 3.0 mg / day for the group consuming iron less than three times a week vs. 9.2 ± 3.3 mg / day for the group consuming iron three or more times a week, P = 0.042). On the other hand, even when iron intake was added as a confounding factor, the group consuming iron three or more times a week showed a significantly lower risk of developing anemia compared to the group consuming iron less than three times a week (hazard ratio 0.235, P = 0.046). Therefore, it was confirmed that the effect of the present disclosure is not due to iron intake.

[0041] 3. Summary The group that had taken a Lacticase Bacillus paracasei-containing composition three or more times a week for the past 10 years had significantly lower anemia incidence and anemia risk than the group that had taken a Lacticase Bacillus paracasei-containing composition less than three times a week for the past 10 years (Table 1, Figure 1, and Table 2, P<0.050). Meanwhile, the relationship between the frequency of lactic acid bacteria-containing composition intake and the risk of anemia was unclear (P=0.109). These results indicated a relationship between the intake of a Lacticase Bacillus paracasei-containing composition and a reduced risk of anemia. This suggests that habitual intake of a Lacticase Bacillus paracasei-containing composition reduces the risk of anemia.

Claims

1. An agent for reducing the risk of developing anemia, containing Lacticase Bacillus paracasei YIT 9029 (FERM BP-1366) as the active ingredient.

2. The agent for reducing the risk of developing anemia according to claim 1, which is taken before the onset of anemia.

3. The agent for reducing the risk of developing anemia according to claim 1 or 2, which is taken three or more times per week.

4. The agent for reducing the risk of developing anemia according to any one of claims 1 to 3, which is to be taken continuously for 10 years or more.

5. A food and beverage containing Lacticase Bacillus paracasei YIT 9029 as an active ingredient to reduce the risk of developing anemia.

6. A food or drink for reducing the risk of developing anemia according to claim 5, which is a fermented food or drink.

7. A food and beverage composition for reducing the risk of developing anemia, containing Lacticase Bacillus paracasei YIT 9029 as an active ingredient.

8. Use of Lacticase Bacillus paracasei YIT 9029 for the manufacture of an agent for reducing the risk of developing anemia.

9. Use of Lacticase Bacillus paracasei YIT 9029 for reducing the risk of developing anemia.

10. A method for reducing the risk of developing anemia in a subject, comprising administering Lacticase Bacillus paracasei YIT 9029 to a subject before the subject develops anemia.

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