JP7164118B2 - Anti-fatigue oral composition - Google Patents

Description

The present invention relates to an anti-fatigue oral composition and the like.

In recent years, since ceramide is a main component of intercellular lipids in human epidermis, the market for ceramide has been expanding as a material for functional cosmetics. It is known that keratin ceramide gradually decreases with aging, and therefore supplementation with topical ceramide is thought to be important for maintaining healthy skin. In addition, free ceramide, which exists as intercellular lipids in the stratum corneum, is free ceramide, and thus free ceramide is also attracting attention.

Research has also been conducted so far to efficiently prepare useful ceramides (for example, Patent Document 1).

JP 2012-126910 A

As for ceramides, research and development have been vigorously conducted on their effects on the skin, but little research and development has been conducted on their other functions.

Accordingly, an object of the present invention is to discover new functions of ceramide.

The present inventors discovered the possibility that orally ingesting ceramide may exhibit an anti-fatigue effect, and have made further improvements to complete the present invention.

The invention includes, for example, the subject matter described in the following sections.
Section 1.
An anti-fatigue oral composition comprising ceramide.
Section 2.
Item 2. The anti-fatigue oral composition according to Item 1, comprising free ceramide.
Item 3.
Ceramide skeleton (sphingoid base having 3 hydroxyl groups, 18 carbon atoms, and 0 or 1 carbon-carbon double bond)-(22 to 26 carbon atoms, 0 carbon-carbon double bonds, hydroxyl group A free ceramide that is a combination of fatty acids having 0, 1, or 2 of the - (fatty acid having 24 or 25 carbon atoms, 0 carbon-carbon double bonds, and 0, 1 or 2 hydroxyl groups),
containing at least one free ceramide selected from the group consisting of
Item 3. The anti-fatigue oral composition according to item 2.
Section 4.
t18:0-22:0h,
t18:1-22:0h,
t18:0-23:0h,
t18:1-23:0h,
t18:0-24:0h,
t18:1-24:0h,
t20:0-24:0h,
t18:1-26:0h,
t18:0-25:0h and t18:0-24:0h ₂
containing at least one free ceramide selected from the group consisting of
Item 4. The anti-fatigue oral composition according to item 3.
Item 5.
5. The anti-fatigue oral composition of paragraph 4, comprising at least t18:0-24:0h, t18:1-24:0h, and t20:0-24:0h.
Item 6.
The total amount of t18:0-24:0h, t18:1-24:0h, and t20:0-24:0h is 30% by mass or more of the total amount of free ceramide contained,
Item 6. The anti-fatigue oral composition according to item 5.
Item 7.
Item 7. The anti-fatigue oral composition according to any one of items 1 to 6, wherein the anti-fatigue is improvement of body fatigue and/or improvement of general malaise.
Item 8.
t18:0-22:0h,
t18:1-22:0h,
t18:0-23:0h,
t18:1-23:0h,
t18:0-24:0h,
t18:1-24:0h,
t20:0-24:0h,
t18:1-26:0h,
t18:0-25:0h and t18:0-24:0h ₂
An oral ceramide composition comprising at least one free ceramide selected from the group consisting of
Item 9.
9. The oral ceramide composition of paragraph 8, comprising at least t18:0-24:0h, t18:1-24:0h, and t20:0-24:0h.
Item 10.
The total amount of t18:0-24:0h, t18:1-24:0h, and t20:0-24:0h is 30% by mass or more of the total amount of free ceramide contained,
10. Oral ceramide composition according to Item 9.
Item 11.
Item 11. The oral ceramide composition according to any one of Items 1 to 10, which is for rapid absorption.
Item 12.
Item 11. The oral ceramide composition according to any one of Items 1 to 10, which is for rapid recovery from fatigue.

The present invention provides an anti-fatigue oral composition. The anti-fatigue oral composition can improve fatigue by oral ingestion.

In addition, in discovering the anti-fatigue effect of oral ingestion of ceramide, the present inventors also found that specific ceramide can be absorbed extremely rapidly and taken into the blood when orally ingested. The inventors have also invented a ceramide oral composition containing a specific ceramide. The oral ceramide composition included in the present invention is particularly excellent in intestinal absorbability and blood transfer due to the inclusion of specific ceramide. Therefore, oral compositions containing these specific free ceramide species are considered to have a high rapid effect upon oral ingestion compared to other ceramides. In addition, as for the effects of known ceramides, they are considered to be more effective when orally ingested than other ceramides.

Before and after oral ingestion of the ceramide composition, POMS (Profile of Mood States) was used to evaluate whether the body is easily tired. Before and after oral ingestion of the ceramide composition, POMS (Profile of Mood States) was used to evaluate the results of "whole body dullness". The ceramide composition was analyzed by LC-MS (high-performance liquid chromatograph-mass spectrometer), and the results of analyzing various free ceramide species contained in the ceramide composition are shown. Fig. 1 shows the results of examining the effects on the skin (transepidermal water loss (TEWL)) of oral ingestion of a ceramide composition. 3 mg of the ceramide composition was orally administered to ICR mice, blood was collected 3 hours after administration, and each free ceramide species present in the plasma was analyzed by LC-MS. An example of free ceramide is represented by a structural formula to help understand the structure of free ceramide. Shown are the results of evaluation of whether "daytime sleepiness is strong" using a mood scale questionnaire before and after oral ingestion of the ceramide composition. Before and after oral ingestion of the ceramide composition, the results of evaluating whether or not the subjects had a "busy feeling" using a mood scale questionnaire are shown. Shown are the results of evaluating whether or not the subject "wants to lie down" using CFS before and after oral ingestion of the ceramide composition. Before and after oral ingestion of the ceramide composition, CFS was used to evaluate whether or not the subject "felt exhausted". Before and after oral ingestion of the ceramide composition, CFS was used to evaluate whether the body felt sluggish. Before and after oral ingestion of the ceramide composition, POMS was used to evaluate whether the subject was "tensed". The results of evaluation of "positive mood" using POMS before and after oral ingestion of the ceramide composition are shown. Before and after oral ingestion of the ceramide composition, POMS was used to evaluate whether the subject was “full of energy”. Before and after oral ingestion of the ceramide composition, the results of evaluation using POMS on whether or not the subject "becomes lively" are shown. Before and after oral ingestion of the ceramide composition, POMS was used to evaluate whether the subject was "tired". Before and after oral ingestion of the ceramide composition, the results of evaluation of "sluggishness" using POMS are shown.

Each embodiment of the present invention will be described in further detail below.

The present invention includes anti-fatigue oral compositions. The anti-fatigue oral composition comprises ceramide. Ceramide is a compound having a structure (--NH--CO--) in which an amino group (--NH ₂ ) of a sphingoid base is bonded to a carboxyl group (--COOH) of a fatty acid. The alcoholic hydroxyl group (--OH) of the sphingoid base of ceramide is further combined with a polar group such as sugar and phosphoric acid to form glycosphingolipids and phosphosphingolipids, respectively. Here, those bound with sugar are particularly called glycosylceramide, and particularly when the sugar is glucose, they are called glucosylceramide. A ceramide in which sugar and phosphoric acid are not bound is particularly called free ceramide. Free ceramide is suitable as the ceramide contained in the anti-fatigue oral composition of the present invention.

The sphingoid base constituting the free ceramide preferably has 2 or 3 hydroxyl groups, more preferably 3 hydroxyl groups. The sphingoid base preferably has 14 to 22 carbon atoms (14, 15, 16, 17, 18, 19, 20, 21, or 22), more preferably 16 to 20 carbon atoms. , and those having 18 or 20 carbon atoms are more preferable. Moreover, those having 0 or 1 carbon-carbon double bond are preferable. More specific preferred sphingoid bases include, for example, sphingosine, dihydrosphingosine, phytosphingosine and the like.

Fatty acids constituting free ceramide preferably have 16 to 30 carbon atoms (16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30). , C18-28 fatty acids are more preferred, C20-26 fatty acids are more preferred, and C22-26 fatty acids are even more preferred. Moreover, fatty acids having 0 or 1 carbon-carbon double bonds are preferred, and fatty acids having 0 carbon-carbon double bonds (that is, saturated fatty acids) are more preferred. Fatty acids having 0, 1, or 2 hydroxyl groups are preferred, and fatty acids having 1 or 2 hydroxyl groups are more preferred. Although not particularly limited, if it has a hydroxyl group, it is preferably an α-hydroxyl group.

In the free ceramide, the (sphingoid base)-(fatty acid) combination of the ceramide skeleton may be any combination of the above sphingoid bases and fatty acids. A particularly preferred combination is, for example, a combination of (sphingoid base having 2 or 3 (especially 3) hydroxyl groups)-(fatty acid having a hydroxyl group (especially having an α-hydroxyl group)). The number of hydroxyl groups of the fatty acid is preferably 0, 1, or 2, more preferably 1 or 2.

For example, ceramide AP, which is a combination of phytosphingosine (P) and a fatty acid with 1 hydroxyl group (A), and ceramide NP, which is a combination of phytosphingosine (P) and a fatty acid with 0 hydroxyl group (N), are preferred. Furthermore, ceramide DP, which is a combination of phytosphingosine (P) and a fatty acid having 2 hydroxyl groups (D), is also preferably exemplified. Ceramide AP and ceramide NP are commonly used terms, but ceramide DP is a term used in this specification and not a commonly used term. Specific examples of ceramide DP include dihydroxylignocellophytosphingosine and the like.

Among them, as a free ceramide, (i) a ceramide skeleton (having 3 hydroxyl groups, 18 carbon atoms, and a sphingoid base having 0 or 1 carbon-carbon double bond)-(22 carbon atoms to 26, a free ceramide that is a combination of fatty acids having 0 carbon-carbon double bonds and 0, 1, or 2 hydroxyl groups, and (ii) a ceramide skeleton (having 3 hydroxyl groups and 20 carbon atoms and a sphingoid base having no carbon-carbon double bond)-(a fatty acid having 24 or 25 carbon atoms, 0 carbon-carbon double bonds, and 0, 1, or 2 hydroxyl groups) free ceramide , is preferred. Among them, more specifically, for example, t18: 0-22: 0h, t18: 1-22: 0h, t18: 0-23: 0h, t18: 1-23: 0h, t18: 0-24: 0h, t18:1-24:0h, t20:0-24:0h, t18:1-26:0h, t18:0-25:0h, and t18:0-24:0h ₂ and the like are preferred. The notation will be explained by taking “t18:0-22:0h” as an example. ”), has “18” carbon atoms, and has “0” carbon-carbon double bonds (that is, has no carbon-carbon double bonds). In addition, the latter part "22:0h" is information about the fatty acid, and is a fatty acid having a carbon number of "22", a carbon-carbon double bond of "0", and one hydroxyl group ("h"). It shows that In addition, "h2" shows having _two hydroxyl groups.

Among the above specific free ceramides, t18:0-24:0h, t18:1-24:0h, and t20:0-24:0h are particularly preferred.

In addition, the anti-fatigue oral composition of the present invention preferably contains at least t18: 0-24: 0h, t18: 1-24: 0h, and t20: 0-24: 0h as free ceramide, and the composition The total amount of t18:0-24:0h, t18:1-24:0h, and t20:0-24:0h relative to the total amount of free ceramide contained in the product is 30% by mass, 40% by mass, or 50% by mass % or more is more preferable.

In addition, each ceramide can be used individually by 1 type or in combination of 2 or more types. Moreover, each ceramide can be prepared by a known method or a method that can be easily conceived from a known method. Also, commercially available ceramide can be purchased and used. For example, natural human ceramide sold as an external cosmetic material by Genuine R&D Co., Ltd. contains many ceramide species preferable for use in the composition according to the present invention, and is suitable. Also, for example, a composition containing ceramide species suitable for the anti-fatigue oral composition of the present invention can be obtained by the method described in Patent Document 1 above.

The anti-fatigue oral composition according to the present invention can be suitably used for recovery from fatigue and/or prevention of fatigue. Fatigue is not particularly limited, but for example, drowsiness (especially daytime sleepiness), feeling of being busy, feeling of fatigue (e.g., feeling tired easily, wanting to lie down, feeling exhausted, feeling sluggish, feeling tense, etc.) feeling), lack of positiveness, lack of fulfillment (feeling full of energy, feeling lively, etc.), etc., and the anti-fatigue according to the present invention for recovery and / or prevention of these Oral compositions can preferably be used.

The anti-fatigue oral composition according to the present invention is preferably used, for example, in the fields of medicine and food. The composition may consist of ceramide alone, or may be a composition containing ceramide and other components (various bases, carriers, additives, etc.), as described in detail below. The ceramide-containing biological tissue extract itself is also included in the composition. In other words, a ceramide-containing biological tissue extract (and one further containing other ingredients if necessary) can also be used as the anti-fatigue oral composition according to the present invention.

When the anti-fatigue oral composition according to the present invention is used in the pharmaceutical field (including pharmaceuticals and quasi-drugs), the composition (hereinafter sometimes referred to as "pharmaceutical composition according to the present invention") is It may consist of various ceramides alone, or may be a pharmaceutical composition containing other ingredients. For example, in the pharmaceutical composition according to the present invention, the active ingredient, ceramide, may optionally be added with pharmaceutically acceptable bases, carriers, additives (e.g., excipients, binders, disintegrants, lubricants, agents, solvents, sweeteners, coloring agents, corrigents, flavoring agents, surfactants, humectants, preservatives, pH adjusters, thickening agents, etc.). Such base materials, carriers, additives and the like are specifically described, for example, in Dictionary of Pharmaceutical Excipients 2016 (Yakuji Nippo Co., Ltd.), and for example, those described therein can be used. The formulation form is also not particularly limited, and the active ingredient and other ingredients are mixed by a conventional method, such as tablets, coated tablets, powders, granules, fine granules, capsules, pills, liquids, suspensions, and emulsions. , jellies, chewables, soft tablets and the like. For example, tablets may be manufactured by a tableting method. Either a direct compression method in which the mixed raw materials are tableted as they are, or a granule compression method in which the mixed raw materials are granulated and then tableted can be used. For example, capsules may be soft capsules or hard capsules.

The amount of ceramide compounded in the pharmaceutical composition according to the present invention is not particularly limited as long as the anti-fatigue effect is exhibited, and can be appropriately set according to the subject. It is preferably 0.0005 to 100% by mass, more preferably 0.005 to 90% by mass, still more preferably 0.05 to 80% by mass. The lower limit may be approximately 10% by mass, 20% by mass, 30% by mass, 40% by mass, 50% by mass, 60% by mass, 70% by mass, or 80% by mass.

Subjects to whom the pharmaceutical composition according to the present invention is administered are not particularly limited, but humans who feel fatigue are suitable. The feeling of fatigue may be felt slightly or strongly. It can also be used prophylactically when physical and/or mental fatigue is expected in the near future.

Furthermore, subjects to which the pharmaceutical composition according to the present invention is administered include not only humans but also non-human mammals. Mammals exhibiting fatigue can be exemplified, and mammals raised as pets and livestock are particularly preferred. Specific examples include dogs, cats, monkeys, cows, horses, sheep, goats, pigs, rabbits, mice, rats, camels, and llamas. In mammals, as in humans, the pharmaceutical composition of the present invention can also be used prophylactically.

The timing of administration of the pharmaceutical composition according to the present invention is not particularly limited, and the timing of administration can be appropriately selected in consideration of, for example, the formulation form, the age of the subject of administration, the degree of symptoms of the subject of administration, and the like. The dosage form is oral administration.

The dosage of the pharmaceutical composition according to the present invention can be appropriately selected according to the age of the subject of administration, the degree of symptoms of the subject of administration, other conditions, and the like. In particular, the amount of ceramide contained as a reference can be appropriately set within a range that does not impair the effects of the present invention. It can be administered once a day or in multiple doses (preferably 2 to 3 times). In the case of mammals as well, the dosage can be appropriately set with reference to the case of the person concerned.

When the anti-fatigue oral composition according to the present invention is used as a food composition (for example, food and drink and food additives), the composition (hereinafter sometimes referred to as "food composition according to the present invention") contains ceramide , and food hygienically acceptable bases, carriers, additives, and other ingredients and materials that can be used as foods and drinks are appropriately blended. For example, processed foods containing ceramide for improving or preventing fatigue, beverages, health foods (foods with nutrient function claims, foods for specified health use, etc.), supplements, food for sick people (hospital food, sick food, nursing care food, etc.), etc. can be exemplified. Although not particularly limited, when the ceramide blended in the food composition is a biological tissue-extracted ceramide extracted from biological (especially animal or plant) tissue, for example, processed foods, health foods ( food with nutrient function claims, food for specified health use, etc.), supplements, food for the sick, and the like. In addition, ceramide is powdered, for example, and contained in various foods and drinks such as beverages (juices, etc.), confectionery, breads, soups (including powdered soups, etc.), and processed foods. may

In addition, when preparing the food composition according to the present invention as a health food (food with nutrient function claims, food for specified health use, etc.) or supplement, it may be prepared, for example, by granules, capsules, tablets (chewable) so as to facilitate continuous intake. It is preferable to prepare it in the form of beverages (drinks), etc. Among them, capsules, tablets, and tablet forms are preferable from the viewpoint of ease of ingestion, but are not particularly limited to these. do not have. The food composition according to the present invention in the form of granules, capsules, tablets and the like can be appropriately prepared according to conventional methods using pharmaceutically and/or food hygienically acceptable carriers. Moreover, even when preparing other forms, conventional methods may be followed.

The amount of ceramide compounded in the food composition according to the present invention is not particularly limited as long as the anti-fatigue effect can be exhibited. , preferably 0.0005 to 100% by mass, more preferably 0.005 to 90% by mass, still more preferably 0.05 to 80% by mass. The lower limit may be approximately 10% by mass, 20% by mass, 30% by mass, 40% by mass, 50% by mass, 60% by mass, 70% by mass, or 80% by mass.

The food composition according to the present invention can be preferably used for improving or preventing fatigue symptoms. In addition, it is preferable that the intake amount, the subject of intake, etc. are the same as those of the pharmaceutical composition according to the present invention described above, for example.

Hospital food is food provided when a person is admitted to a hospital, sick food is food for a sick person, and nursing care food is food for a person being cared for. The food composition according to the present invention is particularly preferable as hospital food, sick food, or nursing care food for patients who are hospitalized, are being treated at home, or who are receiving nursing care and are feeling fatigue. can be used. It can also be used prophylactically when physical and/or mental fatigue is expected in the near future.

The present invention also includes oral ceramide compositions comprising ceramide. The oral ceramide composition also includes an anti-fatigue oral composition containing the above ceramide. In other words, the anti-fatigue oral composition is a preferred embodiment of the oral ceramide composition, and is particularly used for anti-fatigue applications.

The ceramide species and other components contained in the oral ceramide composition according to the present invention are the same as those in the anti-fatigue oral composition described above. However, there are no particular restrictions on the administration target. Not only subjects requiring anti-fatigue effects but also subjects requiring skin function improving effects, for example, are included.

As the ceramide species contained in the oral ceramide composition according to the present invention, free ceramide is preferred, and among these, t18: 0-22: 0h, t18: 1-22: 0h, t18: 0-23: 0h, t18 are preferred. : 1-23: 0h, t18: 0-24: 0h, t18: 1-24: 0h, t20: 0-24: 0h, t18: 1-26: 0h, t18: 0-25: 0h, and t18: 0-24:0h ₂ , etc., and particularly preferred are t18:0-24:0h, t18:1-24:0h, and t20:0-24:0h. Also, at least t18:0-24:0h, t18:1-24:0h, and t20:0-24:0h are preferably included as free ceramide, and the total amount of free ceramide contained in the composition is More preferably, the total amount of t18:0-24:0h, t18:1-24:0h, and t20:0-24:0h is 30% by mass, 40% by mass, or 50% by mass or more.

By containing the specific free ceramide species, the oral ceramide composition according to the present invention is particularly excellent in intestinal absorption and blood transfer. Therefore, oral compositions containing these specific free ceramide species are considered to have a high rapid effect upon oral ingestion compared to other ceramides. In addition, as for the effects of known ceramides, they are considered to be more effective when orally ingested than other ceramides.

In this specification, the term "comprising" includes "consisting essentially of" and "consisting of."

The present invention will be described in more detail below, but the present invention is not limited to the following examples.
Preparation of ceramide composition
With reference to the method described in JP-A-2012-126910, soy sauce lees were extracted with ethanol, followed by solvent fractionation to purify high-purity free ceramide to obtain a ceramide composition.

More specifically, the preparation was performed as follows. That is, a dried product of compressed lees, which is a by-product of soy sauce produced by a conventional method, was subjected to ethanol extraction, and the resulting extract was subjected to solid-liquid separation using ethanol and water to obtain a solid portion. Further, the solid portion was washed with acetone, ethanol and water, dried and pulverized, washed with water, acetone and hexane, and extracted again with ethanol to obtain a solid portion as a ceramide composition.

Examination of anti-fatigue effect by oral intake of ceramide composition 1
Supplement capsules containing 2 mg or 10 mg of ceramide composition per capsule were prepared. Specifically, after mixing lactose and a ceramide composition, the mixture was filled into pullulan hard capsules to prepare supplement capsules. Capsules containing no ceramide composition (filled with lactose only) were also prepared.

40 healthy adults were divided into 13 placebo groups, 14 low dose groups, and 13 high dose groups. A capsule containing 10 mg of the ceramide composition was ingested in the high-dose group, one capsule per day for 28 days (double-blind method). A mood scale questionnaire was taken using POMS (Profile of Mood States) before and after the intake. Evaluation was made on whether "the body is easily tired" and "whether the whole body is dull". These items in POMS are in the form of answering a 5-grade evaluation questionnaire, and the results of analyzing the average values of the answers in each group are shown in FIGS. 1 and 2. FIG.

From the results, it was found that orally ingesting the ceramide composition provides an anti-fatigue effect.

Composition Analysis of Ceramide Composition by LC-MS The ceramide composition was analyzed by LC-MS (high-performance liquid chromatograph-mass spectrometer) to analyze various free ceramide species contained in the ceramide composition. FIG. 3 shows the content ratio (% by mass) of various free ceramide species in the ceramide composition, which was found from the analysis. Three types of free ceramide species, t18:0-24:0h, t18:1-24:0h, and t20:0-24:0h, accounted for 50% by mass or more of the ceramide composition. In addition, it was found that free ceramide was also included.

Investigation of Effect of Oral Ingestion of Ceramide Composition on Skin Hairless mice (female, 7 weeks old) were used to examine the effect of oral ingestion of a ceramide composition on the skin. Hairless mice (n=5) were fed with 0.1% by weight of the ceramide composition in the diet for 2 weeks. Similarly, 0.1% by weight of maize-derived plant glucosylceramide (Nagara Science Co., Ltd.) was added to the diet and given to hairless mice (n=5) for 2 weeks. In addition, hairless mice (n=5) fed a normal diet for 2 weeks were used as controls.

During this study period, the first day, the 7th day, the 11th day, and the 14th day of the study, the transepidermal water loss (TEWL) of each hairless mouse was measured using a Tewameter (manufactured by Courage+Khazaka). The results are shown in FIG. In FIG. 4, the ceramide composition is represented as "ceramide", and the maize-derived plant glucosylceramide is represented as "glucosylceramide".

From the results, it was found that the ceramide composition used had an effect of improving transepidermal water loss (TEWL) by oral intake, and that the effect was higher than that of plant-derived ceramide (corn-derived plant glucosylceramide). I found out.

Examination of Efficiency of Absorption of Ceramide Composition from Intestinal Tract ICR mice were orally administered 3 mg of the ceramide composition, blood was collected 3 hours after administration, and each free ceramide species present in the plasma was analyzed by LC-MS. Blood was also collected from ICR mice to which the ceramide composition was not administered, and the same analysis was performed. The results are shown in FIG. In FIG. 5, the ceramide composition is denoted as "WSS". Free ceramide species marked with a yellow marker indicate those confirmed by MS/MS (other free ceramide species are estimated from molecular ions). Many molecular species similar to the administered ceramide composition were detected in the blood, and based on the results of the analysis after a short time of 3 hours after administration, each administered free ceramide species was absorbed directly from the intestinal tract. It was suggested that In addition, even if it is assumed that ceramide is once decomposed before intestinal absorption and then resynthesized after absorption, each administered free ceramide species is quickly taken into the blood. Therefore, each free ceramide contained in the ceramide composition used, especially the three types of t18:0-24:0h, t18:1-24:0h, and t20:0-24:0h are particularly intestinal absorbable and blood It was found to have excellent transferability. This suggests that compositions containing these specific free ceramide species have a high fast-acting effect when orally ingested among ceramides.

Examination of anti-fatigue effect by oral intake of ceramide composition 2
Supplement capsules containing 2 mg of the ceramide composition per capsule were prepared. Specifically, after mixing the dextran and the ceramide composition, the mixture was filled into pullulan hard capsules to prepare supplement capsules. Capsules containing no ceramide composition (filled with dextran only) were also prepared.
40 healthy adults were divided into 19 people in the placebo group and 20 people in the ceramide group. The placebo group received capsules containing no ceramide composition, and the ceramide group received capsules containing 2 mg of the ceramide composition, one capsule each day. Each was ingested for 84 days (double-blind method). Mood scale questionnaire (by SD method (Semantic Differential Technique)), CFS (Cancer Fatigue Scale: Questionnaire for evaluating fatigue of cancer patients), and POMS (Profile of Mood States) before and after ingestion. was evaluated by Specifically, subjects were asked to answer questionnaires with 16 questions for the mood scale questionnaire, 15 questions for CFS, and 30 questions for POMS, and the answers were tabulated. Specific questionnaire items and evaluation results for each questionnaire are described below.

Mood scale questionnaire items "strong daytime sleepiness" and "feeling busy", CFS questionnaire items "Do you want to lie down?", "Do you feel exhausted?" and POMS questionnaire items "I feel nervous", "I feel positive", "I'm full of energy", "I feel energetic", "I'm tired", and "I'm tired". . The questionnaire on these items was conducted in a format in which the respondents were asked to select which of the following five or four stages applies.
Mood Scale Questionnaire (“Strong daytime sleepiness”): “Not at all” 1 point, “Slightly” 2 points, “A little” 3 points, “Very much” 4 points, “Very much” 5 points Mood Scale Questionnaire (“Busy”): “Not at all busy” 1 point, “Not very busy” 2 points, “Busy” 3 points, “Very busy” 4 points CFS Questionnaire: “No” 1 point, “Slightly” 2 points, "somewhat" 3 points, "quite" 4 points, "very" 5 points POMS questionnaire: "not at all" 1 point, "a little" 2 points, "somewhat" 3 points, " Quite a lot" 4 points, "Very many" 5 points

Figures 7 to 17 show the results of analysis of responses for each item in the placebo group and the ceramide group. In these figures, the ceramide group is indicated as 2 mg group. In addition, before the start of intake and after intake are described as before and after, respectively.

As shown in FIGS. 7 to 17, in all of the above questionnaire items, there was no significant difference between before and after ingestion in the placebo group, but there was a significant difference in the ceramide group. These results also confirmed that oral intake of the ceramide composition provided an anti-fatigue effect.

Claims (6)

An anti-fatigue oral composition comprising free ceramide. Ceramide skeleton (sphingoid base having 3 hydroxyl groups, 18 carbon atoms, and 0 or 1 carbon-carbon double bond)-(22 to 26 carbon atoms, 0 carbon-carbon double bonds, hydroxyl group A free ceramide that is a combination of fatty acids having 0, 1, or 2 of the - (fatty acid having 24 or 25 carbon atoms, 0 carbon-carbon double bonds, and 0, 1 or 2 hydroxyl groups),
containing at least one free ceramide selected from the group consisting of
The anti-fatigue oral composition according to claim 1 . t18:0-22:0h,
t18:1-22:0h,
t18:0-23:0h,
t18:1-23:0h,
t18:0-24:0h,
t18:1-24:0h,
t20:0-24:0h,
t18:1-26:0h,
t18:0-25:0h and t18:0-24:0h ₂
containing at least one free ceramide selected from the group consisting of
The anti-fatigue oral composition according to claim 2 . 4. The anti-fatigue oral composition of claim 3 , comprising at least t18:0-24:0h, t18:1-24:0h, and t20:0-24:0h. The total amount of t18:0-24:0h, t18:1-24:0h, and t20:0-24:0h is 30% by mass or more of the total amount of free ceramide contained,
The anti-fatigue oral composition according to claim 4 . The anti-fatigue oral composition according to any one of claims 1 to 5 , wherein the anti-fatigue is amelioration of body fatigue and/or amelioration of general malaise.

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