Taxifolin-containing composition

Abstract

To put taxifolin to practical use by providing a ground for its functionality to human beings.SOLUTION: A functional composition for human beings contains taxifolin. The composition is for improvement in cognitive function. The functional composition for human beings may be aimed at healthy persons of 50 years or older. The functional composition for human beings may be aimed at persons with mild cognitive impairment.SELECTED DRAWING: None

Description

[Technical field]

[0001] The present invention relates to a functional composition for humans containing taxifolin. [Background technology]

[0002] Taxifolin (also known as dihydroquercetin) is a flavonoid compound found in natural products such as grapes, citrus fruits, onions, green tea, olive oil, larch, milk thistle, French maritime pine bark, Douglas fir bark, and Smilax glabre rhizome. Taxifolin is known to have strong antioxidant activity, and its biological activity is expected to be used to prevent various diseases and improve symptoms. For example, Patent Document 1 describes that administration of taxifolin-containing food to dementia model mice (APPSwDI genetically modified mice) reduced the amount of amyloid beta accumulation in the brain compared to administration of normal food (paragraph 0063 of Patent Document 1). In addition, it is described that administration of taxifolin-containing food to dementia model mice (APPSwDI genetically modified mice) shortens the time it takes to reach the platform each time the mice are tested, similar to that of normal C57BL / 6J mice (paragraph 0072 of Patent Document 1). [Prior art documents] [Patent documents]

[0003] [Patent Document 1] International Publication No. 2017 / 199755 Summary of the Invention [Problem to be solved by the invention]

[0004] Although test results using model mice have been reported, it was not clear how cognitive function would be affected by taxifolin intake in humans.

[0005] Therefore, an object of the present invention is to provide evidence of the functionality of taxifolin in humans and to promote its utilization. [Means for solving the problem]

[0006] In order to achieve the above-mentioned object, the present inventors conducted various studies and found that taxifolin has an action effect of improving human cognitive function, thereby completing the present invention.

[0007] That is, the present invention has the following configuration. [1] A functional composition for humans containing taxifolin, the functional composition for humans being used to improve cognitive function. [2] The functional composition for humans described in [1] above, which is intended for healthy individuals aged 50 or older. [3] The functional composition for humans described in [1] above, which is intended for people with mild cognitive impairment. [4] The functional composition for humans according to the above-mentioned [1], wherein the taxifolin is to be taken in a dose of 50 mg to 150 mg per day for 4 weeks or more. Effect of the Invention

[0008] According to the present invention, by utilizing taxifolin, a material having excellent functionality, such as improving cognitive function in humans, can be provided. [Brief description of the drawings]

[0009] [Figure 1] In Test Example 1, an evaluation was performed using the cognitive function testing tool Cognitrax, and the calculated value of "Number of correct hits (delay)" in the "Visual memory test," one of the test evaluation items, was compared between a test group that ingested a test food containing taxifolin and a test group that ingested a control food not containing taxifolin. [Diagram 2]In Test Example 1, an evaluation was performed using the cognitive function testing tool Cognitrax, and the calculated value of the "number of correct answers (immediate)" in the "visual memory test," one of the evaluation items in the test, was compared between a test group that ingested a test food containing taxifolin and a test group that ingested a control food not containing taxifolin. [Diagram 3] In Test Example 1, an evaluation was performed using the cognitive function testing tool Cognitrax, and the calculated values ​​of "motor speed (the sum of the average of the right hand and the average of the left hand)" in the "finger tapping test," one of the evaluation items in the test, were compared between a test group that ingested a test food containing taxifolin and a test group that ingested a control food not containing taxifolin. [Figure 4] In Test Example 1, an evaluation was performed using the cognitive function testing tool Cognitrax, and the calculated value of the "right hand average" in the "finger tapping test," one of the test evaluation items, was compared between a test group that ingested a test food containing taxifolin and a test group that ingested a control food not containing taxifolin. [Diagram 5] 1 is a chart showing the results of a questionnaire using the Profile of Mood States Second Edition (POMS2) as a secondary evaluation item in Test Example 1. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] Taxifolin used in the present invention is not particularly limited in terms of origin. For example, materials obtained by chemical synthesis may be used, or materials obtained by extraction from natural products may be used. Natural products containing taxifolin include grapes, citrus fruits, onions, green tea, olive oil, larch, milk thistle, French maritime pine bark, Douglas fir bark, and Smilax glabre rhizome. Among them, trees belonging to the genus larch, such as Siberian larch, Dahurian larch, North Pacific larch, and larch, are rich in taxifolin, and can be suitably prepared from these. For example, taxifolin is particularly abundant in the xylem and growing parts, and an extract containing taxifolin can be obtained by drying and grinding the tree and extracting it with water or a water-containing organic solvent, and then fractionating the obtained extract by HPLC. A method for extracting taxifolin from a source plant is known in the art, such as in International Publication No. 2010 / 095969, and taxifolin can be obtained according to the preparation method disclosed therein. In addition, materials containing taxifolin at high purity, such as "Labitol (registered trademark)" (manufactured by AMETIS JSC, imported and sold by DHQ Co., Ltd.), are commercially available, and such commercially available products may be used.

[0011] Taxifolin used in the present invention may be appropriately taken into the body in a desired effective amount so that taxifolin can act. Taxifolin may be, for example, in the form of a glycoside in which sugar is bound to its phenol OH group, or in the form of a salt or solvate. Even in such a form, taxifolin can be released after being taken into the body due to hydrolysis by enzymes such as esterases in the body or ion buffering properties of biological fluids, and this can act. The purity of taxifolin used may be, for example, 10% by mass or more, 20% by mass or more, 30% by mass or more, 40% by mass or more, 50% by mass or more, 60% by mass or more, 70% by mass or more, 80% by mass or more, 90% by mass or more, 95% by mass or more, based on the total amount of the material containing taxifolin. Even if the purity is low, the desired effective amount can be taken into the body by increasing the dosage accordingly.

[0012] In the present invention, the form of taxifolin to be taken into the living body is not particularly limited, but may be prepared in the form of an oral composition for oral intake, or in the form of a parenteral composition for parenteral intake. More specifically, when taken orally, the form may be, for example, a tablet, liquid, syrup, powder, granule, capsule, soft capsule, solid, semi-liquid, cream, paste, etc. Furthermore, when taken parenterally, the form may be, for example, an injection, inhalant, suppository, topical cream, etc. That is, taxifolin can be taken into the living body by being administered to humans or taken by humans by being contained as a part of the components in these normal forms.

[0013] In the above-mentioned composition forms, the content of taxifolin may be such that an effective amount is taken in when the form is applied to humans, and is not limited thereto, but typically, for example, taxifolin may be present in an amount of 0.01 parts by mass or more, 0.1 parts by mass or more, 1 part by mass or more, 5 parts by mass or more, 10 parts by mass or more, 20 parts by mass or more, etc., per 100 parts by mass of the composition. Also, taxifolin may be present in an amount of 100 parts by mass or less, 90 parts by mass or less, 80 parts by mass or less, 70 parts by mass or less, 60 parts by mass or less, 50 parts by mass or less, etc., per 100 parts by mass of the composition.

[0014] Taxifolin can be quantified using known techniques such as HPLC analysis.

[0015] In any non-limiting aspect, the present invention may be in the form of application of, for example, food and drink, medicine, or supplement.

[0016] In the above-mentioned application form, the content of taxifolin is not limited as long as an effective amount is taken in when the form is applied to humans, but typically, for example, in the case of a tablet form of 150 mg to 300 mg per tablet, taxifolin may be contained in 2% by mass to 40% by mass, 4% by mass to 30% by mass, 5% by mass to 30% by mass, etc. In addition, for example, in the case of a drink form of a bottle with a content of 50 to 500 mL, taxifolin may be contained in 0.01 w / v% to 1 w / v% per bottle, 0.05 w / v% to 1 w / v%, or 0.1 w / v% to 1 w / v% per bottle. In addition, when in the form of a hard capsule with a content of 200 mg to 350 mg, the taxifolin may be contained in an amount of 5% by mass or more and 70% by mass or less, 10% by mass or more and 60% by mass or less, or 30% by mass or more and 50% by mass or less, per content.

[0017] Taxifolin is a material that can be used by humans without health problems based on dietary experience. Its dosage can be appropriately set and is not limited, but the daily intake for an adult can be 10 mg or more and 400 mg or less, 20 mg or more and 300 mg or less, or 30 mg or more and 200 mg or less. The intake period can be, for example, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks, 14 weeks, 15 weeks, 16 weeks, 17 weeks, 18 weeks, 19 weeks, 20 weeks, etc., and it can be used to be taken over these periods.

[0018] As shown in the test examples described below, taxifolin has the effect of improving human cognitive function.

[0019] Therefore, the present invention can provide a functional composition for humans (a) having the following configuration: (a) A functional composition for humans for improving cognitive function.

[0020] Although not limited thereto, the functional composition for humans provided by the present invention may further comprise one or more of the following components. (a1) It is aimed at healthy individuals aged 50 or older. (a2) It is aimed at people with mild cognitive impairment. (a3) Taxifolin is intended for taking 50 mg to 150 mg per day for four weeks or more.

[0021] In the above embodiment, the subject may be 55 years of age or older, 60 years of age or older, 65 years of age or older, 70 years of age or older, 75 years of age or older, or 80 years of age or older. The intake period may be 5 weeks or more, 6 weeks or more, 7 weeks or more, 8 weeks or more, 9 weeks or more, 10 weeks or more, 11 weeks or more, or 12 weeks or more. Mild cognitive impairment (MCI) is a pre-stage of dementia, a state between normal and disease, and is considered to be an important opportunity to prevent dementia (Suzuki Yutaka, "Mild Cognitive Impairment," Nihon University Medical Journal, 2012; 71(6): 385-389.). That is, for mild cognitive impairment (MCI), progression to dementia can be suppressed at this stage, and normal cognitive function can be maintained.

[0022] Furthermore, cognitive function includes various elements, and according to the test examples described below, it is possible to prevent decline in cognitive functions such as, but not limited to, visual memory for recognizing and remembering shapes, and cognitive functions related to mobility and motor control by improving or maintaining these cognitive functions. EXAMPLES

[0023] The present invention will be described in detail below with reference to examples, but the scope of the present invention is not limited to these examples.

[0024] <Test Example 1> We investigated how the intake of taxifolin affects human cognitive function. Specifically, we conducted tests using the cognitive function testing tool Cognitrax (provided by Health Solution Co., Ltd., developed by CNS Vital Signs, Inc.).

[0025] [1. Target] The subjects were healthy Japanese men and women aged 55 to 80 years who were aware of forgetfulness or had been told they had forgetfulness.

[0026] 2. Test Foods The test foods were hard capsules containing larch extract powder containing 90% by mass of taxifolin along with other excipients. The control foods were hard capsules without larch extract powder. Table 1 shows the composition of each test food per capsule.

[0027] [Table 1]

[0028] [3. Examination Schedule] Sixty individuals were selected from those deemed suitable for participation in the study by the responsible physician or other appropriate personnel, and were assigned to two groups based on age, sex, and the calculated values ​​(standardized scores) from a prior Cognitrax test and the measured values ​​of blood amyloid beta, using these as allocation adjustment factors to ensure there was no bias.

[0029] Participants were asked to take one tablet of each test food twice a day, after breakfast and after dinner, for 12 weeks. Cognitrax tests were conducted before intake (which also served as a pre-test), at each visit after 6 weeks of intake, and after 12 weeks of intake, and standardized scores (converted values ​​for comparison with participants of the same age, calculated with the mean being 100 and the standard deviation being 15) were calculated for each of the cognitive-related test evaluation items.

[0030] In addition, as secondary evaluation items, blood amyloid beta levels were measured using a commercially available kit, "Human / Rat Beta Amyloid (42) ELISA Kit Wako, High Sensitivity (Code No. 292-64501)" (FUJIFILM Wako Pure Chemical Corporation), and a questionnaire was conducted using the mood profile test tool (POMS2: Profile of Mood States Second Edition).

[0031] [4. Analysis method] Statistical differences between test groups were analyzed using unpaired t-tests for evaluations based on comparisons between the control and test food groups at the time of testing, and paired t-tests (Bonferroni method) for evaluations based on comparisons over time from before intake to 6 or 12 weeks after intake.

[0032] [5. Analysis results] As shown in Figure 1, at 6 and 12 weeks after intake, the test food intake group showed an improvement in the calculated "number of correct hits (delay)" in the "visual memory test," a test evaluation item in which participants recognize and remember figures displayed on a screen, compared to the control food intake group.

[0033] As shown in Figure 2, the calculated "number of correct answers (immediate)" in the above-mentioned "visual memory test" was improved in the test food intake group at 6 and 12 weeks after intake, compared to the control food intake group.

[0034] As shown in Figure 3, at 6 and 12 weeks after ingestion, the test food intake group showed improvements in the calculated "motor speed (the sum of the average of the right hand and the average of the left hand)" in the finger tapping test, a laboratory evaluation item in which participants tap the space bar on a keyboard as quickly as possible with the index finger of either the right or left hand, compared to the control food intake group.

[0035] As shown in Figure 4, the group that consumed the test food showed improvements in the calculated "right hand average" scores in the above-mentioned "finger tapping test" at 6 and 12 weeks after ingestion, compared to the group that consumed the control food.

[0036] As shown in Figure 5, in a questionnaire using the mood profile testing tool POMS2, the "TMD: Overall Negative Mood" category showed a downward trend in the test food intake group compared to the control food intake group, indicating a better mood state.

[0037] On the other hand, no statistically significant differences were observed in the blood amyloid beta measurements between the test food intake group and the control food intake group.

[0038] Furthermore, no severe or serious adverse events were observed in this study, and it was considered that there were no safety issues with continued intake of the test food.

[0039] These studies demonstrated that taxifolin has the effect of improving human cognitive function, in particular visual memory for recognizing and remembering shapes, as well as cognitive functions related to mobility and motor control.

Claims

1. A functional composition for humans containing taxifolin, the functional composition for humans being intended for healthy individuals aged 55 or older, for improving cognitive function related to visual memory.

2. 2. The functional composition for humans according to claim 1, wherein the taxifolin is taken in a dose of 50 mg to 150 mg per day for 4 weeks or more.

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