JP7780911B2 - Foods, beverages, quasi-drugs, or pharmaceuticals containing lactic acid bacteria that have hair growth and hair restoration effects - Google Patents

Description

NPMD NITE BP-03233

The present invention relates to a food, drink, quasi-drug, or pharmaceutical product containing lactic acid bacteria of the species Lactobacillus plantarum, or a culture medium or fermentation product thereof, which has a hair growth and hair restoration effect on the human body.

Hair serves to protect the head from external forces and from light such as ultraviolet rays and visible light, and also plays a major role in the appearance of the head from the perspective of fashion and beauty.
Hair has a hair cycle, in which it grows and falls out at regular intervals, and the hair cycle can be divided into a growth phase, a regression phase, and a resting phase.

On the other hand, due to issues such as aging, some individuals may be more susceptible to hair loss depending on their constitution, and various methods such as hair growth agents, quasi-drugs, cosmetics, etc. are used to deal with such hair loss and thinning hair on the head.
Various prior patent applications have been published as methods for dealing with such hair loss and thinning hair, but generally, compounds such as minoxidil and finasteride are often used.
On the other hand, in recent years, as a method other than using such compounds, vigorous research has been conducted into lactic acid bacteria for the purpose of maintaining health, and methods for promoting hair growth, hair regrowth, and inhibiting hair loss using lactic acid bacteria have also been disclosed.

Patent Publication No. 2015-187171

Patent Document 1 describes a method that utilizes a specific strain of lactic acid bacteria belonging to the genus Lactococcus, but the experimental results thereof utilize dermal papilla cells and measure the production amounts of FGF-7 and VEGF, which are growth factors secreted from the dermal papilla cells, and it is pointed out that the results are not obtained by actually administering the method to humans.

Therefore, the present inventors focused on new lactic acid bacteria and set out to develop a method for using such lactic acid bacteria to achieve hair growth and other effects on the human body.
In particular, the objective was to develop a food, drink, quasi-drug, or pharmaceutical product that utilizes the lactic acid bacteria and that has been confirmed to be useful for hair growth, etc., when actually orally ingested by humans.

The present inventors screened various lactic acid bacteria and, taking advantage of the fact that activation of dermal papilla cells is essential for achieving hair growth, hair care and hair restoration effects, screened multiple lactic acid bacteria using activation of dermal papilla cells as an indicator and selected lactic acid bacteria.
Furthermore, they prepared food and beverages using the lactic acid bacteria and conducted clinical trials in which people (subjects) actually ingested the products, confirming their effectiveness, thereby completing food and beverages with high hair growth effects.

That is, the first invention of the present application is:
"Food, beverages, quasi-drugs or pharmaceuticals containing lactic acid bacteria that have hair growth or hair development effects in the human body, or their culture fluid or fermentation products."

Next, the food or drink containing the lactic acid bacteria may have a name selected from the group consisting of names of refreshing confectionery, lactic acid bacteria-containing food, lactic acid bacteria drink, and soft drink.
That is, the second invention of the present application is:
"The food or beverage, quasi-drug or pharmaceutical containing the lactic acid bacteria, its culture solution or fermentation product according to claim 1, wherein the food or beverage is any one selected from the group consisting of refreshing confectionery, lactic acid bacteria-containing food, lactic acid bacteria drink and soft drink."

Next, the food or drink containing the lactic acid bacteria of the present invention may be in the form of a solid tablet, for example.
That is, the third invention of the present application is:
"A food, drink, quasi-drug or pharmaceutical containing the lactic acid bacteria, its culture solution or fermentation product according to claim 1 or 2, wherein the food, drink, quasi-drug or pharmaceutical is in the form of a tablet."

Next, the lactic acid bacteria are preferably lactic acid bacteria belonging to the species Lactobacillus plantarum.
That is, the fourth invention of the present application is:
"The food or drink, quasi-drug, or pharmaceutical product according to any one of claims 1 to 3, wherein the lactic acid bacterium, its culture solution, or fermentation product belongs to the species Lactobacillus plantarum."

Next, the lactic acid bacteria is preferably Lactobacillus plantarum N793 strain (NITE BP-03233).
That is, the fifth invention of the present application is:
"The food or drink, quasi-drug, or pharmaceutical product according to any one of claims 1 to 4, wherein the lactic acid bacterium, its culture solution, or its fermentation product is Lactobacillus plantarum N793 strain (NITE BP-03233)."

By using and orally administering a food or drink, quasi-drug, or pharmaceutical product containing the lactic acid bacteria of the present invention, or its culture medium or fermentation product, it is possible to naturally suppress hair loss and thinning in the human body.

FIG. 1 shows the results of evaluation of dermal papilla cell activation ability in an example. FIG. 1 shows the results of the total number of hairs analyzed in a clinical trial. FIG. 10 is a diagram showing the results of hair thickness from hair analysis in a clinical trial. FIG. 1 shows the results of the number of non-vellus hairs in a hair analysis in a clinical trial. FIG. 1 shows the results of non-vellus hair rate from hair analysis in a clinical trial. FIG. 1 shows the results of hair analysis of vellus hair counts in a clinical trial. FIG. 1 shows the results of vellus hair rate from hair analysis in a clinical trial. FIG. 1 shows the results of hair loss analysis from hair analysis in a clinical trial. FIG. 10 is a diagram showing the results of a VAS questionnaire on the sensation of hair loss during hair washing. FIG. 10 is a diagram showing the results of a VAS questionnaire on the sensation of hair loss when styling hair. FIG. 1 is a diagram showing the results of a VAS questionnaire on the feeling of lack of hair firmness and strength. FIG. 10 is a diagram showing the results of a VAS questionnaire on the perception of hair thinness. FIG. 10 is a diagram showing the results of a VAS questionnaire on the feeling of lack of hair strength. FIG. 10 is a diagram showing the results of a VAS questionnaire on the feeling of hair lack in volume. FIG. 10 is a diagram showing the results of a VAS questionnaire on the sense of visibility of the scalp. FIG. 10 is a diagram showing the results of a VAS questionnaire on the sense of visibility of the top of the head, hairline, and parting. FIG. 10 is a diagram showing the results of a VAS questionnaire on perception of the amount of hair loss.

The present invention will be described below with reference to examples, but the present invention is not limited to the following examples.
The first invention of the present application is "a food, drink, quasi-drug or pharmaceutical product containing lactic acid bacteria that have a hair growth or hair development effect in the human body."

Hair growth or hair care effect The hair growth or hair care effect referred to in the present invention refers to the effect of increasing the number of hairs, thickening the hair, reducing hair loss, etc., and refers to any one or more of these effects.

Lactic acid bacteria Examples of the present invention are described below, but the present invention is not limited to the following examples.
Preparation of Lactic Acid Bacteria An example of the lactic acid bacteria used in the present invention is preferably a lactic acid bacterium of the genus Lactobacillus, more specifically, a lactic acid bacterium of the species Lactobacillus plantarum.
In the present invention, any lactic acid bacteria of the species Lactobacillus plantarum can be used, but among these, it is particularly preferable to use the following strains of lactic acid bacteria of the species Lactobacillus plantarum.

1. Lactobacillus plantarum strain N793 (NITE BP-03233)
The lactic acid bacterium of the present invention is Lactobacillus plantarum. In particular, among lactic acid bacteria belonging to the genus Lactobacillus plantarum, the Lactobacillus plantarum N793 strain (NITE BP-03233) is used. The symbol N793 used in the present invention is a number uniquely assigned to the strain by Nissin Foods Holdings Co., Ltd., and the Lactobacillus plantarum N793 strain was first discovered by the present inventors.

More specifically, the Lactobacillus plantarum N793 strain has been identified as a lactic acid bacterium belonging to the Lactobacillus plantarum subsp. plantarum species.

The Lactobacillus plantarum strain N793 of the present invention was deposited on June 18, 2020, at the Patent Microorganisms Depositary of the National Institute of Technology and Evaluation under NITE BP-03233. The bacteriological properties of the Lactobacillus plantarum strain N793 of the present invention are shown in Tables 1 and 2. These bacteriological properties were determined according to the method described in Bergey's Manual of Systematic Bacteriology, Vol. 2 (1986). Table 1 shows the morphology and other characteristics of this strain, and Table 2 shows the results of a test of sugar utilization using API 50CH and API CHL (manufactured by bioMérieux). In Table 2, "+" indicates positive and "-" indicates negative.

Lactic acid bacteria powder, its culture solution, or fermentation product The lactic acid bacteria of the present invention can be used in various forms. For example, in the case of lactic acid bacteria powder, the lactic acid bacteria can be freeze-dried or enzyme-treated and freeze-dried.
Furthermore, in addition to lactic acid bacteria powder, a culture solution of the lactic acid bacteria of the present invention can also be used. Specifically, either a culture solution containing bacterial cells or a culture supernatant can be used. Of course, the bacterial cells can be centrifuged or treated with an enzyme such as a protease or lipase, as needed.

Furthermore, it may be a fermentation product obtained by using lactic acid bacteria powder or its culture solution together with the lactic acid bacteria. In other words, fermentation products obtained by purifying compounds, peptides, etc. produced by the lactic acid bacteria during the fermentation process can also be used. Specific examples include equol and GABA.

Foods and Drinks The lactic acid bacteria powder of the present invention, its culture solution or fermentation product can be used by being contained in foods and drinks.
First, the food and drink of the present invention can be formulated by adding appropriate carriers and additives to the lactic acid bacteria powder, its culture solution, or its fermentation product, as needed, specifically in various forms such as powder, granules, capsules, tablets, powders, coated tablets, liquids, syrups, juices, etc.

Furthermore, the food and beverage products containing the lactic acid bacteria powder of the present invention, its culture medium, or its fermentation product may contain the bacteria of the present invention, its culture medium, or its fermentation product as active ingredients, and may of course also contain other ingredients.
Specific examples include sugars (starch, dextrin, polysaccharides, monosaccharides, disaccharides, etc.), proteins, various amino acids, lipids, water, vitamins, minerals, flavorings, various food additives, and the like.

Furthermore, the lactic acid bacteria of the present invention can be used in beverages. Examples include fermented milk containing lactic acid bacteria and lactic acid bacteria beverages containing lactic acid bacteria. While the current Ministerial Ordinance on the Compositional Standards of Milk and Dairy Products does not specifically stipulate the number of lactic acid bacteria as a component of the standard, fermented milk (with a non-fat milk solids content of 8.0% or more) and lactic acid bacteria beverages (with a non-fat milk solids content of 3.0% or more) preferably have a lactic acid bacteria count of 1.0 x 10 ⁷ cfu/ml or more, and lactic acid bacteria beverages (with a non-fat milk solids content of less than 3.0%) preferably have a lactic acid bacteria count of 1.0 x 10 ⁶ cfu/ml or more. These bacterial counts can be achieved by growing the bacteria in a fermented liquid such as milk or in the form of a final product. In addition to fermented milk and lactic acid bacteria beverages containing lactic acid bacteria, the present invention can also be used in dairy products such as butter, egg products such as mayonnaise, and sweet breads such as butter cake. It can also be used in processed foods such as instant noodles and cookies.

Furthermore, the lactic acid bacteria of the present invention, their culture solution or fermentation product can also be usefully contained in foods for specified health uses, nutritional supplements, functional foods, etc., in addition to general foods and beverages.
The names of the foods and beverages in the present invention are not particularly limited, and examples thereof include refreshing confectionery, lactic acid bacteria-containing foods, lactic acid bacteria drinks, and soft drinks, but are of course not limited to these.

Quasi-drugs and pharmaceuticals The lactic acid bacteria powder, its culture solution, or fermentation product of the present invention can be used by being incorporated into orally ingested quasi-drugs and pharmaceuticals, in addition to foods.Specific examples include orally ingestible forms such as drinks and tablets.
That is, the lactic acid bacteria of the present invention, its culture solution, or fermentation product can be extracted or powdered by concentration, separation, or the like, and then used as a quasi-drug or pharmaceutical product containing the ingredient as an active ingredient. For example, the extract can be bottled, or the dried powder of the fermentation solution can be granulated or encapsulated using an excipient or compressed into tablets.

Furthermore, quasi-drugs and pharmaceuticals may contain the lactic acid bacteria powder of the present invention, its culture solution, or fermentation products as an active ingredient, and may of course contain other ingredients (e.g., sugars, proteins, amino acids, lipids, water, vitamins, minerals, etc.) in addition to the active ingredient.

1. Screening of Lactic Acid Bacteria Lactic acid bacteria to be used in foods and drinks, quasi-drugs, or pharmaceuticals containing the lactic acid bacteria powder of the present invention, its culture solution, or fermentation product were screened as follows.
The hair cycle is a cycle in which hair goes through three phases: growth, catagen, and resting. The longest period of the hair cycle is the growth phase, which usually lasts for 3 to 6 years.

The anagen phase is maintained by growth factors such as keratinocyte growth factor, insulin-like growth factor 1, and vascular endothelial growth factor. These growth factors are produced by dermal papilla cells located deep within the hair root. Keratinocyte growth factor secreted from dermal papilla cells acts directly on hair matrix cells, which are the source of hair, and is known to promote the growth and division of hair matrix cells, making it thought to be the growth factor that acts most directly on hair. Based on the above, dermal papilla cells are necessary for hair growth, and it is surmised that activating dermal papilla cells will lead to hair growth. For this reason, we evaluated the ability of various lactic acid bacteria to activate dermal papilla cells.

The lactic acid bacteria species tested were Lactobacillus plantarum (3 species),
Lactobacillus casei/paracasei (3 species), Lactobacillus rhamnosus (3 species), Lactobacillus fermentum (3 species), Lactobacillus reuteri (3 types) and Lactobacillus lactis (3 types).

2. Dermal papilla cell activation test <Preparation of test sample (lactic acid bacteria powder suspension)>
Lactic acid bacteria were cultured in the MRS medium (manufactured by Becton Dickinson) shown in Table 3 at 37°C for 24 hours. The grown bacteria were then collected using a centrifuge. The collected bacteria were washed with sterilized water and collected using a centrifuge. Washing and collection were repeated three times. After heat sterilization at 95°C for 15 minutes, bacteria were again collected using a centrifuge. The collected bacteria were freeze-dried using a freeze dryer to obtain a lactic acid bacteria powder. The lactic acid bacteria powder was suspended in PBS (PBS (-) pH 7.4, manufactured by Gibco) to a concentration of 1 mg/mL to prepare a lactic acid bacteria powder suspension.

<Evaluation of dermal papilla cell activation ability>
The dermal papilla cell activation activity of the test samples (lactic acid bacteria powder suspensions) obtained above was evaluated. Specifically, human dermal papilla cells were seeded into a 96-well plate at a density of 1.2 x 10 ⁴ cells/well and cultured in a CO ₂ incubator (5% CO ₂ , 37°C) for 6 hours, after which 100 μL of D-MEM medium (FBS 4%) containing each test sample (final concentration 1%) was added. After addition, the cells were incubated in a CO ₂ incubator (5% CO ₂ , 37°C) for 72 hours, and the number of dermal papilla cells in the culture medium was measured by absorptiometry. Cell Counting Kit-8 (manufactured by Dojindo Laboratories) was used for the measurement. PBS (PBS(-) pH 7.4, manufactured by Gibco) was used as a control. The dermal papilla cell activation activity was evaluated based on the dermal papilla cell activation rate, with the control set to 1. The measurement results are shown in Table 4. As shown in Table 4, it was found that Lactobacillus plantarum has a high ability to activate hair follicle dermal papilla cells.
The test results are shown in Table 4. The results are shown in a graph in Figure 1.
─Test Results─

As a result, it was found that Lactobacillus plantarum (3 species) has a high ability to activate hair follicle papilla cells.

2. Intake test in clinical trial The above-mentioned dermal papilla cell activation test revealed that Lactobacillus plantarum has high activity. Of the three strains tested, the N793 strain (NITE BP-03233), which had the highest activity, was tested in a clinical trial to verify its effectiveness.

2-1. Production of lactic acid bacteria-containing foods - Cultivation of lactic acid bacteria Lactic acid bacteria were cultured in the MRS medium (manufactured by Becton Dickinson) shown in Table 3 at 37°C for 24 hours. The grown cells were then collected using a centrifuge. The collected cells were washed with sterilized water and collected using a centrifuge. Washing and collection were repeated three times. After heat sterilization at 95°C for 15 minutes, the cells were again collected using a centrifuge. The collected cells were freeze-dried using a freeze dryer to obtain a lactic acid bacteria powder.

〇 Production of the test food (lactic acid bacteria-containing food) of the example A lactic acid bacteria-containing food was produced by blending lactic acid bacteria powder and excipients. The excipients contained reduced maltose starch syrup, powdered cellulose, calcium stearate, and fine silicon dioxide. The raw materials were mixed thoroughly using a rocking mixer. For the tableting process, the mixture was sieved through a mesh and tableted using a tablet press. The prepared lactic acid bacteria-containing food had the ingredient composition shown in Table 5.

The nutritional components (per tablet) of the lactic acid bacteria-containing food are shown in Table 6.

We have completed the production of a food product (tablets) containing lactic acid bacteria. Clinical trials were conducted using the tablets as test meals.

・Subjects Subjects were selected based on the following criteria 1) to 4).
1) Japanese men and women aged 20 to 59 at the time of consent. 2) Subjects who are aware of thinning hair. 3) Subjects who can agree to maintain their current hair styling methods (hair length, hairstyle, perm, etc.), hair dyeing methods (hair dye), and hair washing methods (hair wash) during the study period. 4) Subjects who can agree to a local haircut by a professional (a 1cm x 1cm area approximately 3cm to the right of the horizontal line connecting the midline of the head and the top of the left and right ear helices was clipped with clippers, leaving a length of approximately 0.5mm). The actual number of subjects was 13. Of these, there were 6 men and 7 women. The average age was 50.23±1.95 years.

Feeding Method The feeding method for the test foods described above was as shown in Table 7.

- Schedule for observing the subject's head hair The observation schedule for the subject's head hair was carried out according to the following schedule.
The number of observations was six, and the observation times were before use, 2 days after use, 12 weeks after use, 12 weeks + 2 days after use, 24 weeks after use, and 24 weeks + 2 days after use. The test food was consumed at home for 168 days.

Test Results To observe the subject's head hair (hair analysis), a digital microscope (HIROX, KH-2000) was used to examine the hair in the local hair-cut area (1 cm x 1 cm) described above.
Test items included hair analysis, including total number of hairs, number of hairs, hair thickness, number of non-vellus hairs, and hair loss analysis. Statistical analysis was performed using Dunnett's test between before intake and 12 weeks after intake, and between before intake and 24 weeks after intake (+: P < 0.1 *: P < 0.05 **: P < 0.01 ***: P < 0.001). +: P < 0.1 was determined to indicate a significant trend, and P < 0.05 was determined to indicate a significant difference. The results for each item are shown below.

Hair analysis/total number of hairs: 163.7±10.4 hairs before intake, 169.1±10.6 hairs after 12 weeks of intake, and 175.8±11.3 hairs after 24 weeks of intake. Compared to before intake, the number increased by 5.4 hairs after 12 weeks of intake and 12.1 hairs after 24 weeks of intake, with a significant difference observed after 24 weeks of intake (P=0.006). The results are shown in Table 8.

The graph is also shown in FIG.

Hair analysis/hair thickness: 58.9±3.3 μm before ingestion, 61.0±3.4 μm after 12 weeks of ingestion, and 62.7±3.1 μm after 24 weeks of ingestion. Compared to before ingestion, the number of hairs increased by 2.1 after 12 weeks of ingestion and 3.8 after 24 weeks of ingestion, with a significant trend observed after 12 weeks of ingestion (P<0.1). A significant difference was also observed after 24 weeks of ingestion (P=0.001). The results are shown in Table 9.

The graph is also shown in Figure 3.

Hair analysis/Number of non-vellus hairs (firm, hard hairs, hair diameter 40 μm or more) μ
The number of firm, hard hairs with a diameter of 40 μm or more was 121.2 ± 12.3 before ingestion, 131.8 ± 13.2 after 12 weeks of ingestion, and 141.0 ± 12.3 after 24 weeks of ingestion. Compared to before ingestion, the number significantly increased by 10.6 hairs (P = 0.025) after 12 weeks of ingestion and 19.8 hairs (P < 0.001) after 24 weeks of ingestion. The results are shown in Table 10.

The graph is also shown in FIG.

Hair Analysis/Non-Vellus Hair Rate The non-vellus hair rate (%) for firm, hard hairs with a diameter of 40 μm or more was calculated as the number of non-vellus hairs in the localized cut area divided by the total number of hairs. The non-vellus hair rate was 74.8±5.9 before intake, 78.3±6.2 after 12 weeks of intake, and 80.8±5.4 after 24 weeks of intake. Compared to before intake, the rate increased by 3.5% after 12 weeks of intake and 6.0% after 24 weeks of intake, with a significant trend observed after 12 weeks of intake (P<0.1). A significant difference was also observed after 24 weeks of intake (P=0.002). The results are shown in Table 11.

The graph is also shown in FIG.

Hair analysis/number of vellus hairs The number of soft hairs (vellus hairs) with a diameter of less than 40 μm was 42.5±11.6 before intake, 37.2±11.3 after 12 weeks of intake, and 34.8±10.4 after 24 weeks of intake. Compared to before intake, the number decreased by 5.3 after 12 weeks of intake and 7.7 after 24 weeks of intake, with a significant difference observed after 24 weeks of intake (P=0.021). The results are shown in Table 12.

The graph is also shown in FIG.

Hair Analysis/Vellus Hair Rate The vellus hair rate (%) for soft hair (vellus hair) with a hair diameter of less than 40 μm was calculated as the number of vellus hairs in the local cut area divided by the total number of hairs. The vellus hair rate was 25.2±5.9 before intake, 21.7±6.2 after 12 weeks of intake, and 19.2±5.4 after 24 weeks of intake. Compared to before intake, the rate decreased by 3.5% after 12 weeks of intake and 6.0% after 24 weeks of intake, with a significant trend observed after 12 weeks of intake (P<0.1). A significant difference was observed after 24 weeks of intake (P=0.002). The results are shown in Table 13.

The graph is also shown in FIG.

Hair analysis/hair loss analysis After washing and drying by a hairdresser, the number of fallen hairs was collected and measured. Before intake, the number was 109.5±15.4 hairs, after 12 weeks of intake it was 78.6±12.8 hairs, and after 24 weeks of intake it was 75.9±15.4 hairs. Compared to before intake, there was a tendency for the number of hairs to decrease by 30.9 hairs (P<0.1) after 12 weeks of intake and by 33.6 hairs (P<0.1) after 24 weeks of intake. The results are shown in Table 14.

The graph is also shown in FIG.

VAS Questionnaire A questionnaire using the Visual Analogue Scale method (VAS questionnaire) was conducted regarding the sensation of hair loss when washing hair, the sensation of hair loss when styling hair, the actual sensation of hair loss, the fineness of hair, and the strength of hair.
The Visual Analogue Scale questionnaire (VAS questionnaire) involves having the subject draw a vertical line on a 100 mm line segment with extreme states at both ends, representing the subject's subjective sensation at the time of filling out the questionnaire, and measuring the length from the end to the vertical line to obtain the VAS score. This is a method for evaluating the subject's subjective sensation.

In this evaluation, for example, when rating "feeling of hair loss when washing hair," participants were asked to answer on a 100mm line, with the left end representing "feeling of no hair loss when washing hair (hair from the drain, hair on the towel used to dry hair, etc.)" (score 0) and the right end representing "feeling of extremely bad hair loss when washing hair (hair from the drain, hair on the towel used to dry hair, etc.)" (score 100). Therefore, the smaller the number, the better the evaluation.

1) Hair loss when washing hair (hair in the drain, hair on the towel used to dry hair, etc.)
The mean values were 71.5±5.8 before ingestion, 60.2±8.3 after 12 weeks, and 47.8±7.0 after 24 weeks. Compared to the mean values before ingestion, the mean values were 11.3 after 12 weeks and 23.7 after 24 weeks, showing a significant difference after 24 weeks of ingestion (P=0.001). The results are shown in Table 15.

The graph is also shown in FIG.

2) Sensation of hair loss when styling hair (drying, brushing, hand combing, etc.) Before ingestion, it was 65.5±6.1, after 12 weeks of ingestion it was 53.5±7.9, and after 24 weeks of ingestion it was 46.9±7.4. Compared to before ingestion, it decreased by 12.0 after 12 weeks of ingestion and 18.6 after 24 weeks of ingestion, and a significant trend was observed after 12 weeks of ingestion (P<0.1). A significant difference was also observed after 24 weeks of ingestion (P=0.007). The results are shown in Table 16.

The graph is also shown in FIG.

3) Hair loss: Before intake, it was 70.8±4.9, after 12 weeks it was 61.3±4.8, and after 24 weeks it was 53.4±4.3. Compared to before intake, it decreased by 9.5 after 12 weeks and by 17.4 after 24 weeks, with a significant difference observed after 24 weeks of intake (P=0.029). The results are shown in Table 17.

The graph is also shown in FIG.

4) Sensation of hair thinness Before ingestion, it was 76.4±4.8, after 12 weeks it was 67.5±6.2, and after 24 weeks it was 57.2±4.8. Compared to before ingestion, it decreased by 8.9 after 12 weeks and by 19.2 after 24 weeks, and a significant difference was observed after 24 weeks of ingestion (P=0.024). The results are shown in Table 18.

The graph is also shown in FIG.

5) Feeling of lack of hair strength: Before intake, it was 65.0±6.5, after 12 weeks it was 60.6±6.7, and after 24 weeks it was 46.5±6.9. Compared to before intake, it decreased by 4.4 after 12 weeks and by 18.5 after 24 weeks, with a significant difference observed after 24 weeks of intake (P=0.044). The results are shown in Table 19.

The graph is also shown in FIG.

6) Feeling of lack of hair volume: Before intake, it was 77.8±5.6, after 12 weeks it was 76.7±5.0, and after 24 weeks it was 59.3±6.3. Compared to before intake, it decreased by 1.1 after 12 weeks and by 18.5 after 24 weeks, with a significant difference observed after 24 weeks of intake (P=0.022). The results are shown in Table 20.

The graph is shown in FIG.

7) Scalp visibility: Before intake, it was 78.0±6.3, after 12 weeks it was 77.8±4.5, and after 24 weeks it was 63.4±4.9. Compared to before intake, it decreased by 0.2 after 12 weeks and by 14.6 after 24 weeks, and a significant trend was observed after 24 weeks of intake (P<0.1). The results are shown in Table 21.

The graph is also shown in FIG.

8) Prominence of the crown, hairline, and parting: Before intake, it was 80.8±5.0, after 12 weeks it was 80.5±4.5, and after 24 weeks it was 63.5±4.3. Compared to before intake, it decreased by 0.3 after 12 weeks and by 17.3 after 24 weeks, with a significant difference observed after 24 weeks of intake (P=0.013). The results are shown in Table 22.

The graph is also shown in FIG.

9) Perception of hair loss Before intake, it was 67.3±8.5, after 12 weeks it was 60.5±4.8, and after 24 weeks it was 44.4±4.8. Compared to before intake, it was reduced by 6.8 after 12 weeks and by 22.9 after 24 weeks, with a significant difference observed after 24 weeks of intake (P=0.011). The results are shown in Table 23.

The graph is shown in FIG.

Claims (3)

A food or drink containing Lactobacillus plantarum N793 strain (NITE BP-03233) lactic acid bacteria , which has a hair growth or hair development effect in the human body, or a culture solution or fermentation product thereof . A food or beverage containing lactic acid bacteria, its culture liquid or fermentation product as described in claim 1, wherein the food or beverage is any one selected from the group consisting of names of refreshing confectionery, lactic acid bacteria-containing food, lactic acid bacteria drink and soft drink . 3. A food or drink containing the lactic acid bacteria, its culture solution or fermentation product according to claim 1 or 2, in the form of a tablet .