Oral composition

Abstract

To provide an oral composition for promoting defecation or the like to be newly used for humans or the like.SOLUTION: The oral composition for suppressing body weight gain, suppressing visceral fat accumulation, promoting lipid excretion, anti-obesity and / or promoting defecation contains silk powder.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to an oral composition for promoting defecation, for example, for use in humans, etc. [Background technology]

[0002] In recent years, the number of people suffering from constipation has been increasing due to dietary changes resulting from the Westernization of eating habits, chronic lack of exercise, and increased social stress. Constipation is common among women and the elderly, and its relief is highly anticipated. Major methods for relieving constipation include preventative and ameliorative methods such as improving diet and light exercise, as well as medicinal treatment. In addition, there is a need for the development of oral compositions for promoting bowel movements (Patent Document 1).

[0003] [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Patent Publication No. 2010-150188 Summary of the Invention [Problem to be solved by the invention]

[0005] The problem to be solved by the present invention relates to an oral composition for promoting defecation, for use in humans, etc. [Means for solving the problem]

[0006] Therefore, the inventors of the present invention have conducted extensive research and have completed the following invention. Specifically, the present invention includes the following items. [Item 1] An oral composition containing silk powder for suppressing weight gain, suppressing visceral fat accumulation, promoting lipid excretion, anti-obesity, and / or promoting bowel movements. [Effects of the Invention]

[0007] The present invention can provide a novel oral composition for promoting defecation containing silk powder. DETAILED DESCRIPTION OF THE INVENTION

[0008] Hereinafter, an embodiment of the present invention will be described.

[0009] (Silk powder) Silk powder is a powder made from cocoons (such as those of the silkworm moth Bombyx mori (Linnaeus, 1758) (Bombycidae)) and is composed of a polymeric protein called silk fibroin, which is the main component of silk fibers. The powder is finely ground to a specific particle size (1 μm to 150 μm) to facilitate the absorption of lipids and other components in the body when the oral composition is ingested (to ensure a certain density structure in the oral composition, etc.). The particle size is preferably (10 to 120 μm), more preferably (15 to 100 μm), and even more preferably (20 to 80 μm) to maximize the desired effect (absorption). Examples of production methods include a method of pulverizing silk fibers to produce water-insoluble silk powder, a method of obtaining silk powder by dehydrating a recrystallized silk aqueous solution, a method of obtaining silk powder by freezing, thawing, separating, and drying a recrystallized silk aqueous solution, and a method of hydrolyzing silk fibers (see, for example, JP 2007-006762 A).The silk powder described in the following examples of the present application is a silk powder containing fibroin from which sericin has been removed by hot water degumming of silkworm cocoon shells or silk thread.

[0010] Methods for obtaining a predetermined particle size of the powder include, for example, dry grinding, wet grinding, low-temperature grinding, dry grinding, heat grinding, freeze grinding, etc. Examples include a ball mill, jet mill, bead mill, hammer mill, roller mill, and vibration ball mill.

[0011] Silk powder containing fibroin from which sericin has been removed by subjecting silkworm cocoon shells or silk thread to a specific degumming process (such as alkali degumming (e.g., J. Sericult. Sci. Japan, 43(6), 492-494, 1974) or hot water degumming) can be produced, for example, by the following method: The silkworm cocoon shells or silk thread are placed in an explosion machine, and high-pressure steam is introduced to perform an explosion treatment by heating and pressurizing. By such heating and pressurizing, the fibroin, although water-insoluble, is decomposed into short chains. Water is added to the thus-obtained exploded fibroin to prepare an aqueous solution. The aqueous solution thus prepared is dried by a specific drying method (such as spray drying) to produce a powder.

[0012] Silkworms used to produce raw materials for silkworm cocoon shells or silk thread may be either domesticated or wild. Commercially available explosion machines can be used, such as those with a well-known structure (e.g., JP 2005-307041 A, Figure 3) that incorporates a pressure-resistant reactor equipped with a high-pressure / superheated steam inlet, an on-off valve, and a release channel. Steam at 200-250°C is introduced into the reactor, and the reactor is maintained at a pressure of 0.3-3 MPa for a predetermined period of 2-120 minutes. The valve is then opened and the reactor is instantly released to atmospheric pressure. The fibroin undergoing hydrolysis, heated and pressurized by the superheated steam, is physically destroyed by the pressure generated when the molecular structure expands from its internal to external positions. Preferred heating and pressurizing conditions for steam explosion include a pressure of 0.5-3.546 MPa (5-35 atm), with high-pressure steam at 220°C maintained for 30 seconds to 40 minutes.

[0013] The content of silk powder contained in the oral composition can be appropriately set, for example, taking into consideration the defecation promoting effect and the content of other ingredients. In one embodiment, the silk powder is preferably contained in an amount of 1% by mass or more and 100% by mass or less, more preferably 2% by mass or more and 100% by mass or less, and even more preferably 3% by mass or more and 100% by mass or less, based on the total mass of the oral composition. From the viewpoint of safety,

[0014] The daily intake of silk powder used in the present invention (when taken as an oral composition) can be adjusted as appropriate depending on the intake form, purpose of use, age, body weight, etc., but in order to achieve the desired effect, the daily intake for an adult human, calculated as dry matter of silk powder, is preferably 10 mg / kg / day or more, more preferably 25 mg / kg / day or more, and even more preferably 50 mg / kg / day or more, and from the perspective of safety for humans when taking it, it is preferably 1000 mg / kg / day or less, more preferably 750 mg / kg / day or less, and even more preferably 500 mg / kg / day or less.

[0015] (visceral fat) Visceral fat is fat accumulated around the internal organs inside the abdominal and back muscles, and is distinct from subcutaneous fat located on the surface of the torso. The area occupied by visceral fat in a cross section of the torso at the navel (hereinafter referred to as visceral fat cross-sectional area) is commonly used as an index of visceral fat mass. Visceral fat mass is measured using image analysis methods such as X-ray CT (Computed Tomography) or MRI (Magnetic Resonance Imaging). In this image analysis method, the visceral fat cross-sectional area is geometrically calculated from cross-sectional images of the torso acquired using X-ray CT or MRI (see JP 2012-40094 A).

[0016] (obesity) In Europe and the United States, a body mass index (BMI) of 25-30 is defined as overweight, and a BMI of 30 or higher is defined as obese. In Japan, obesity is defined as a BMI of 25 or higher. The Japan Society for the Study of Obesity defines "obesity" as a diagnosis of obesity when one or more of the following conditions are present: (1) impaired glucose tolerance, (2) dyslipidemia, (3) hypertension, (4) hyperuricemia or gout, (5) coronary artery disease, (6) cerebral infarction, (7) fatty liver, (8) menstrual abnormalities, (9) sleep apnea syndrome, (10) orthopedic disease such as osteoarthritis, or (11) obesity-related nephropathy, or when visceral fat accumulation obesity is present even in the absence of any of the above 11 conditions (Nippon Nai Kai Zasshi 103:753-759, 2014, Trends and Prospects for New Anti-Obesity Drugs).

[0017] (promote defecation) The promotion of defecation includes increasing the frequency and amount of defecation when the frequency and amount of defecation are less than normal, and suppressing a decrease in the normal frequency of defecation.

[0018] (insulin resistance) Insulin resistance is a condition in which insulin's main function of promoting glucose absorption, which is its primary function, is weakened in the liver, adipocytes, skeletal muscles, etc. The anti-insulin resistance effect is, for example, the inhibition or delay of worsening of a value that is an indicator of current or future insulin resistance, or the improvement of that value, as confirmed using the SSPG method (Steady-state plasma glucose, Clinical Pharmacology, Jpn J Clin Pharmacol Ther 27(1) Mar 1996 p373) in a subject.

[0019] (Oral composition) The oral composition according to the present invention is, for example, a food or drink (including functional foods, foods for specified health uses, supplements, etc.), a pharmaceutical product, or the like.

[0020] For example, when the oral composition is a food or beverage, the food or beverage may take the form of various foods and beverages such as breads, cakes, noodles, confectioneries, jellies, frozen foods, ice cream, dairy products, beverages, etc., as well as forms similar to those of the oral administration preparations described above (tablets, capsules, syrups, etc.) Foods in various forms can be prepared by using the active ingredient of the present invention alone or in appropriate combination with other food ingredients, solvents, softeners, oils, emulsifiers, preservatives, flavorings, stabilizers, colorants, antioxidants, moisturizers, thickeners, etc.

[0021] For example, when the oral composition is a pharmaceutical, the pharmaceutical is generally easy to formulate a convenient daily dosage regimen that can be adjusted according to the degree of pain, and the pharmaceutical form may be, for example, a solid form or a liquid form. Such solid forms include, for example, powders, tablets, pills, capsules, cachets, lozenges, suppositories, and dispersible granules. For example, in powders, the carrier is generally a finely divided solid that is mixed with a finely divided active ingredient. For example, in tablets, the active ingredient is generally mixed with a carrier having the necessary binding capacity in an appropriate ratio and compacted into the desired shape and size. Suitable carriers may include, but are not limited to, magnesium carbonate, magnesium stearate, talc, sugar, lactose, pectin, dextrin, starch, gelatin, tragacanth, methylcellulose, sodium carboxymethylcellulose, low-melting wax, cocoa butter, etc. The pharmaceutical may also contain ingredients such as excipients, stabilizers, preservatives, binders, disintegrants, hydrocarbons, fatty acids, alcohols, esters, pH adjusters, and preservatives as needed, within the range that does not impair the desired effects.

[0022] The present invention will now be described in more detail with reference to the following examples, but the present invention is not limited to these examples. In the following examples, the unit % used to indicate the amount of each component added means % by mass. [Example]

[0023] Examples of the present invention will be described below. The samples used in the experiments are as follows: Animals: C57Bl / 6JmsSlc mice (8-week-old males, Japan SLC Co., Ltd.) Silk powder: Silk powder (water-insoluble powder) containing fibroin (particle size: 1 μm to 150 μm) obtained by refining silkworm cocoon shells or silk thread to remove sericin. was prepared. Solid feed (MF): Oriental Yeast Co., Ltd. High-fat diet: D12451 (45kcal% fat content, lard used, (High Fat Diet), Research Diet Co., Ltd.). Diet used in Group 1: diet containing the high-fat diet and cornstarch (final concentration 10%). Diet used in Group 2: diet containing the high-fat diet and silk powder (final concentration 10%)

[0024] [Experiment 1: Test using laboratory animals (mice)] Using laboratory animals (mice), changes in body weight and other factors were measured (tested) after ingestion of an oral composition containing silk powder.

[0025] (Test Method) The test method is described below. First, 14 C57Bl / 6J mice were obtained. The obtained mice were kept under normal conditions for one week (with free access to the solid feed (MF) and water). After this normal condition, their weights were measured. After measuring their weights, the following 32 experimental groups were established (the time point at which these groups were established was designated as day 0), and the mice were kept under these conditions (with free access to water and the solid feed corresponding to the following groups) for 8 weeks (56 days).

[0026] Group 1: A group fed the same feed as Group 1. Food intake was measured twice a week, and any leftover food was discarded. Group 2: The group was fed the same feed as Group 2. Food intake was measured twice a week, and any leftover food was discarded.

[0027] During the eight-week period, the following measurement samples were collected: Once a week (7 days after 0 to 14 days after 0 to 28 days after 0 to 35 days after 0 to 42 days after 0 to 49 days after 0 to 56 days after 0 to 56 days after 0 to 56 days), weight was measured and recorded, and all feces in the cage were collected. The collected feces were stored for each individual and for one week at a time.

[0028] After 8 weeks (56 days from the day 0), the following measurement samples were collected. The animals were dissected and the weight of visceral fat was measured. After the dissection, feces were collected from the large intestine of the animal, and the collected feces was immediately stored in liquid nitrogen. Cryopreservation was carried out. Using frozen and preserved feces, the bacterial flora was analyzed by amplicon sequencing (Seiso Giken Co., Ltd.).

[0029] (Test results) The test results are listed below. (Weight measurement results) The results of body weight measurements are shown in Table 1. The results shown in Table 1 are the calculated average values ​​(units of g) for the samples (7 animals) of each group. After two weeks, a significant (p<0.05, Student's t-test) suppression of weight gain was confirmed in Group 2 (the group that consumed food containing silk powder) compared to Group 1.

[0030] [Table 1]

[0031] (Visceral fat weight measurement results) Table 2 shows the results of measuring visceral fat weight after 8 weeks. The results shown in Table 2 are the average values ​​calculated for the samples (7 animals) of each group. Compared to Group 1, Group 2 (the group that consumed food containing silk powder) showed a significant (p<0.05, Student's t-test) suppression of visceral fat accumulation.

[0032] [Table 2]

[0033] (Fecal volume measurement results) The weight measurement results are shown in Table 3. The results shown in Table 3 are the calculated average values ​​(units of g) of the samples (7 animals) from each group. It was confirmed that Group 2 (the group that ingested food containing silk powder) produced a larger amount of feces (promoted defecation) than Group 1.

[0034] [Table 3]

[0035] (Results of measuring the amount of lipids in feces) Table 4 shows the results of measuring the lipid content of frozen and preserved feces (feces from 7 to 8 weeks). The lipid content was calculated according to the chloroform-methanol mixed liquid extraction method (Ministry of Education, Culture, Sports, Science and Technology: Chapter 5 of the Analysis Manual for the Standard Tables of Food Composition in Japan, 2015 Edition (7th revision)). The results shown in Table 3 are the results of calculating the average value of the samples (7 animals) from each group. It was confirmed that the amount of fat in the feces was higher in Group 2 (the group that consumed food containing silk powder) than in Group 1 (promoting lipid excretion).

[0036] [Table 4]

[0037] (Bacterial flora analysis results) Table 5 shows the mean (%) and median (%) percentages of bacteria in the Bacteroidetes phylum, and Table 6 shows the mean (%) percentage of bacteria in the Firmicutes phylum. It is believed that the intestinal flora of obese individuals is dominated by bacteria in the Firmicutes phylum, while the intestinal flora of obese individuals is dominated by bacteria in the Bacteroidetes phylum (Journal of the Japanese Society of Nutrition 104:703-709, 2015, Intestinal Microbiota and Obesity, Figure 3, etc.). As shown in Table 5, the proportion of bacteria in the Bacteroidetes phylum was higher in Group 2 (the group that consumed a diet containing silk powder) than in Group 1. As shown in Table 6, the proportion of bacteria in the Firmicutes phylum was lower in Group 2 (the group that consumed a diet containing silk powder) than in Group 1.

[0038] [Table 5]

[0039] [Table 6]

[0040] The above has described the embodiments (including examples) of the present invention with reference to the drawings, but the specific configuration of the present invention is not limited to this, and even if there are design changes, etc., within the scope that does not deviate from the gist of the present invention, they are included in the present invention. [Industrial Applicability]

[0041] The present invention can provide a novel oral composition for use in humans, etc., for promoting defecation, etc.

Claims

[Claim 1] An oral composition containing silk powder for suppressing weight gain, suppressing visceral fat accumulation, promoting lipid excretion, anti-obesity and / or promoting defecation.

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