Pollinosis suppression agent, defecation improvement agent, and skin disorder improvement agent
Mechabu, rich in water-soluble dietary fiber, offers new health benefits when ingested as seaweed, effectively addressing hay fever, bowel issues, and skin diseases, with notable improvements in quality of life and symptom reduction.
Patent Information
- Application Number
- JP2023175358
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2023-10-10
- Publication Date
- 2025-04-22
AI Technical Summary
There have been no reports on the functionality of mechabu when ingested as seaweed, despite its potential health benefits.
Mechabu containing 4.5% or more by mass of water-soluble dietary fiber is used as a hay fever inhibitor, defecation improvement agent, and skin disease amelioration agent, with recommended daily intake ranging from 30g to 200g.
The use of mechabu with high water-soluble dietary fiber content effectively suppresses hay fever, improves bowel movements, and ameliorates skin diseases, as demonstrated by significant improvements in quality of life and symptom reduction in clinical trials.
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Figure 2025065864000001_ABST
Abstract
Description
[Technical field]
[0001] The present invention relates to an agent for suppressing hay fever, an agent for improving bowel movements, and an agent for improving skin diseases. [Background technology]
[0002] Seaweed such as wakame, kombu, and hijiki are traditional ingredients in Japanese cuisine and have been eaten in Japan since ancient times. Many recent studies have shown that seaweed is very good for your health.
[0003] Among them, Mekabu is the root (sporophyll) of the brown algae Undaria pinnatifida, and contains various polysaccharides such as fucoidan and alginic acid (see, for example, Non-Patent Document 1). Fucoidan is a polysaccharide whose main component is fucose, and has been reported to have many physiological activities such as immunostimulatory effects. In addition, alginic acid has been reported to have various effects such as blood pressure lowering effects (see, for example, Non-Patent Document 2). [Prior art documents] [Non-patent literature]
[0004] [Non-Patent Document 1] H. Ohnogi, Y. Naito, Y. Higashimaru, K. Uno, T. Yoshikawa, Japanese Journal of Complementary and Alternative Medicine, 2015, 12(2), 87-93.
[0005] [Non-Patent Document 2] Keisuke Tsuji, Etsuko Tsuji, Yasue Nakagawa, Shinjiro Suzuki, Journal of the Japan Association of Home Economics, 1988, 39(3), 187-195. Summary of the Invention [Problem to be solved by the invention]
[0006] While there have been reports on the functionality of fucoidan and alginic acid extracted from Mekabu, there have been no reports yet on the functionality of ingesting the seaweed Mekabu itself.
[0007] The present invention has been made in consideration of the above-mentioned circumstances, and aims to provide Mekabu, a seaweed that has new functionality when ingested as such. [Means for solving the problem]
[0008] The present inventors have conducted extensive research to solve the above-mentioned problems. As a result, they have found that Mekabu containing 4.5% by mass or more of water-soluble dietary fiber has an effect of suppressing hay fever and improving bowel movements, and have completed the present invention. Specifically, the present invention provides the following.
[0009] (1) A pollen allergy suppressant containing Mekabu seaweed containing 4.5% by mass or more of water-soluble dietary fiber.
[0010] (2) The pollen allergy suppressant according to (1), which is taken in an amount of 30 g or more and 200 g or less per day, calculated as Mekabu.
[0011] (3) A bowel movement improving agent containing Mekabu, which contains 4.5% by mass or more of water-soluble dietary fiber.
[0012] (4) The defecation improver according to (3), wherein the amount of the mekabu taken is 30 g or more and 200 g or less per day.
[0013] (5) A skin disease improving agent containing Mekabu containing 4.5% by mass or more of water-soluble dietary fiber.
[0014] (6) The skin disease improving agent according to (5), in which the amount of the mekabu taken is 30 g or more and 200 g or less per 11 days. Effect of the Invention
[0015] According to the present invention, it is possible to provide Mekabu, a seaweed that has new functionality when ingested as such. [Brief description of the drawings]
[0016] [Figure 1] These are the scores for "sneezing" before and after ingestion of the test substance group and the placebo group. [Diagram 2] These are the "daily life" scores before and after intake of the test substance group and the placebo group. [Diagram 3] These are the "social life" scores before and after intake of the test substance group and the placebo group. [Figure 4] These are the "sleep" scores before and after intake for the test substance group and the placebo group. [Diagram 5] These are the "mental life" scores before and after intake of the test substance group and the placebo group. [Figure 6] This is the total score of the "DLQI" before and after intake of the test substance group and the placebo group. [Figure 7] These are the "daily life" scores before and after intake of the test substance group and the placebo group. [Figure 8] These are the "treatment" scores before and after intake of the test substance and placebo groups. [Figure 9] These are the "CAS" scores before and after intake of the test substance group and the placebo group. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0017] Hereinafter, an embodiment of the present invention will be described, however, the present invention is not limited to this embodiment and can be practiced with appropriate modifications.
[0018] <Hay fever suppressant> The pollen allergy suppressant according to this embodiment contains Mekabu, which contains 4.5% by mass or more of water-soluble dietary fiber.
[0019] In this specification, "mass %" refers to the amount relative to the total amount of Mekabu, which is taken as 100 mass %. Also, "Mekabu" refers to the part formed at the base (sporophylls) of Undaria pinnatifida, a brown alga.
[0020] According to the present inventors, it has been found that Mekabu containing 4.5% by mass or more of water-soluble dietary fiber has an effect of suppressing hay fever and can be used as a pollen allergy suppressant.
[0021] The content of water-soluble dietary fiber in Mekabu is not particularly limited, but is preferably, for example, 4% by mass or more, 4.5% by mass or more, 5% by mass or more, 5.5% by mass or more, or 6% by mass or more. On the other hand, the content of water-soluble dietary fiber in Mekabu is preferably 19% by mass or less, 18.5% by mass or less, 18% by mass or less, 17.5% by mass or less, 17% by mass or less, 16.5% by mass or less, 16% by mass or less, 15.5% by mass or less, 15% by mass or less, 14.5% by mass or less, 14% by mass or less, 13.5% by mass or less, or 13% by mass or less.
[0022] The moisture content in Mekabu is not particularly limited, but is preferably 80% by mass or more, 81% by mass or more, 82% by mass or more, 83% by mass or more, 84% by mass or more, or 85% by mass or more. On the other hand, the moisture content of Mekabu is preferably 94% by mass or less, 93% by mass or less, 92% by mass or less, 91% by mass or less, 90% by mass or less, 89% by mass or less, 88% by mass or less, or 87% by mass or less. The moisture contained in Mekabu includes not only the moisture held by the fiber of Mekabu, but also the moisture held by the sticky components derived from Mekabu's fucoidan and alginic acid, and all moisture contained in the moisture present around Mekabu independently of Mekabu. Here, the moisture content is measured by near-infrared spectroscopy.
[0023] The sodium content in the cotyledonary node is not particularly limited, but for example, it is preferably 0.025% by mass or more, 0.027% by mass or more, 0.03% by mass or more, 0.032% by mass or more, 0.035% by mass or more, 0.037% by mass or more, 0.04% by mass or more, 0.042% by mass or more, 0.045% by mass or more, 0.047% by mass or more, 0.05% by mass or more, 0.052% by mass or more, 0.055% by mass or more, 0.057% by mass or more, 0.06% by mass or more, 0.062% by mass or more, 0.065% by mass or more, 0.067% by mass or more, 0.07% by mass or more, 0.072% by mass or more, 0.075% by mass or more, 0.077% by mass or more, 0.08% by mass or more. On the other hand, the sodium content in the cotyledonary node may be 10% by mass or less, 9.5% by mass or less, 9% by mass or less, 8.5% by mass or less, 8% by mass or less, 7.5% by mass or less, 7% by mass or less, 6.5% by mass or less, 6% by mass or less, 5.5% by mass or less, 5% by mass or less, 4.5% by mass or less, 4% by mass or less, 3.5% by mass or less, 3% by mass or less, 2.5% by mass or less, 2% by mass or less, 1.8% by mass or less, 1.6% by mass or less, 1.5% by mass or less, 1.4% by mass or less, 1.3% by mass or less, 1.2% by mass or less, 1.0% by mass or less, 0.9% by mass or less, 0.8% by mass or less, 0.7% by mass or less, 0.6% by mass or less, 0.5% by mass or less, 0.4% by mass or less, 0.3% by mass or less, 0.28% by mass or less, 0.26% by mass or less, 0.25% by mass or less, 0.24% by mass or less, 0.22% by mass or less, 0.2% by mass or less, 0.19% by mass or less, 0.18% by mass or less, 0.17% by mass or less, 0.16% by mass or less, 0.15% by mass or less, 0.14% by mass or less, 0.13% by mass or less, 0.12% by mass or less, 0.11% by mass or less, 0.1% by mass or less, 0.09% by mass or less. Here, the sodium content is measured by the ion electrode method.
[0024] The content of glutamic acid in Mekabu is not particularly limited, but is preferably 0.001% by mass or more, 0.0011% by mass or more, 0.0012% by mass or more, 0.0013% by mass or more, or 0.0014% by mass or more. On the other hand, the content of glutamic acid in Mekabu may be 0.02% by mass or less, 0.019% by mass or less, 0.018% by mass or less, 0.017% by mass or less, 0.016% by mass or less, 0.015% by mass or less, 0.014% by mass or less, 0.013% by mass or less, or 0.012% by mass or less.
[0025] The content of nitrate nitrogen in Mekabu is not particularly limited, but is preferably 500 ppm or less, 490 ppm or less, 480 ppm or less, 470 ppm or less, 460 ppm or less, 450 ppm or less, 440 ppm or less, 430 ppm or less, 420 ppm or less, 410 ppm or less, 400 ppm or less, 390 ppm or less, 380 ppm or less, 370 ppm or less, 360 ppm or less, 350 ppm or less, 340 ppm or less, 330 ppm or less, 320 ppm or less, 310 ppm or less, 300 ppm or less, 290 ppm or less, 280 ppm or less, or 270 ppm or less. On the other hand, the content of nitrate nitrogen in Mekabu is preferably 100 ppm or more, 120 ppm or more, 150 ppm or more, 170 ppm or more, or 200 ppm or more.
[0026] In one embodiment, the width of one piece of the mekabu is not particularly limited, but is preferably, for example, 0.5 mm or more, 0.6 mm or more, 0.7 mm or more, 0.8 mm or more, 0.9 mm or more, 1 mm or more, 1.1 mm or more, 1.2 mm or more, 1.3 mm or more, 1.4 mm or more, 1.5 mm or more, 1.6 mm or more, 1.7 mm or more, 1.8 mm or more, 1.9 mm or more, or 2 mm or more. On the other hand, the width of one piece of the mekabu is preferably 2 mm or less, 1.9 mm or less, 1.8 mm or less, 1.7 mm or less, 1.6 mm or less, or 1.5 mm or less.
[0027] The length of one piece of Mekabu is not particularly limited, but is preferably, for example, 4 mm or more, 5 mm or more, 6 mm or more, 7 mm or more, 8 mm or more, 9 mm or more, 10 mm or more, 11 mm or more, 12 mm or more, 13 mm or more, 14 mm or more, or 15 mm or more. On the other hand, the length of one piece of Mekabu is preferably 150 mm or less, 140 mm or less, 130 mm or less, 120 mm or less, 110 mm or less, 100 mm or less, 90 mm or less, 80 mm or less, 70 mm or less, 60 mm or less, 50 mm or less, 40 mm or less, or 30 mm or less.
[0028] Furthermore, the thickness of one piece of Mekabu is not particularly limited, but is preferably, for example, 0.5 mm or more, 0.6 mm or more, 0.7 mm or more, 0.8 mm or more, 0.9 mm or more, 1 mm or more, 1.1 mm or more, 1.2 mm or more, 1.3 mm or more, 1.4 mm or more, 1.5 mm or more, 1.6 mm or more, 1.7 mm or more, 1.8 mm or more, 1.9 mm or more, or 2 mm or more. On the other hand, the thickness of one piece of Mekabu is preferably 2 mm or less, 1.9 mm or less, 1.8 mm or less, 1.7 mm or less, 1.6 mm or less, or 1.5 mm or less.
[0029] In addition, the "length" of mekabu refers to the dimension in the longest direction, the "width" of mekabu refers to the dimension in the direction perpendicular to the length, which is the next longest dimension after the length, and the "thickness" of mekabu refers to the dimension in the direction perpendicular to the length, which is the shortest dimension.
[0030] Furthermore, there may be pieces in the mekabu that do not satisfy the above dimensional requirements (or a combination of requirements if there are multiple dimensional requirements), and the proportion of pieces that do not satisfy the dimensional requirements (or a combination of requirements if there are multiple dimensional requirements) may be, for example, 10% or less, 5% or less, or 1% or less, based on the number of pieces.
[0031] The kinetic viscosity of Mekabu is 8.2mm / g 2 As long as it is equal to or more than this, it is not particularly limited, but for example, 8.3 mm / g 2 More than 8.4mm / g 2 More than 8.5mm / g 2Above, 8.6mm / g 2 On the other hand, the kinetic viscosity of Mekabu is preferably 30 mm / g or more. 2 Below, 29mm / g 2 Below, 28mm / g 2 Below, 27mm / g 2 Below, 26mm / g 2 Below, 25mm / g 2 Below, 24mm / g 2 Below, 23mm / g 2 Below, 22mm / g 2 Below, 21mm / g 2 Below, 20mm / g 2 Below, 19mm / g 2 Below, 18mm / g 2 Below, 17mm / g 2 Below, 16mm / g 2 Below, 15mm / g 2 It may be the following:
[0032] The mekabu may be raw, may have seasonings added thereto, may be heated mekabu that has been subjected to heat treatment such as boiling, baking or steaming, or may be heated and further added with seasonings.
[0033] Mekabu may contain other ingredients in addition to the above-mentioned ingredients such as water and water-soluble dietary fiber. As the other ingredients, seasonings, preservatives, gelling agents, viscosity regulators, etc. may be used.
[0034] The amount of the pollen allergy suppressant to be taken is not particularly limited, but is preferably 30 g or more, 32 g or more, or 35 g or more per day in terms of Mekabu. On the other hand, the amount of the pollen allergy suppressant to be taken is preferably 200 g or less, 190 g or less, 180 g or less, 170 g or less, 160 g or less, 150 g or less, 140 g or less, 130 g or less, 120 g or less, 110 g or less, 100 g or less, 90 g or less, 80 g or less, 70 g or less, or 60 g or less in terms of Mekabu.
[0035] [Manufacturing method] The method for producing the mekabu contained in the pollen allergy suppressant of this embodiment is not particularly limited, but for example,2 The method includes a boiling step of boiling Mekabu having an area of 100°C or more and not subjected to heat treatment at 70°C or higher in salt-containing water at 70°C or higher and 100°C or lower, a cooling step of immersing the boiled Mekabu in water at 0°C or higher and 40°C or lower to cool it, and a cutting step of cutting the cooled Mekabu into pieces having a width of 0.5 mm to 2 mm.
[0036] (Boiling process) The boiling process is 400 mm. 2 This process involves boiling Mekabu, which has an area of 100°C or more and has not been heat-treated at 70°C or higher, in salt-containing water at a temperature of 70°C or higher and 100°C or lower.
[0037] The surface area of the wakame before boiling is 400 mm 2 There is no particular limitation as long as the area is 500 mm or more. 2 Above 600mm 2 Above 700mm 2 Above 800mm 2 Above 900mm 2 It is preferable that the area of the mekabu before boiling is equal to or more than the above. On the other hand, the area of the mekabu before boiling is not particularly limited, since the larger the mekabu, the more preferable it is. The area refers to the area of the mekabu that is attached to the stem in a pleated form (a surface perpendicular to the thickness). In this way, by making the area of the mekabu before boiling equal to or more than the required value, the contact area with seawater when boiled can be reduced, and the outflow of glutamic acid and water-soluble dietary fiber into salt-containing water can be reduced.
[0038] The wakame before boiling is not particularly limited as long as it has the above-mentioned area and has not been subjected to heat treatment at 70° C. or higher. In one embodiment, raw wakame that has not been subjected to heat treatment may be used.
[0039] The salt-containing water is not particularly limited as long as it is water containing salt. In one embodiment, the salt-containing water may contain sodium chloride. The content of sodium chloride is not particularly limited, but is preferably 1% by mass or more, 1.5% by mass or more, 2% by mass or more, or 2.5% by mass or more relative to the total amount of the salt-containing water. On the other hand, the content of sodium chloride is preferably 10% by mass or less, 9.5% by mass or less, 9% by mass or less, 8.5% by mass or less, 8% by mass or less, 7.5% by mass or less, 7% by mass or less, 6.5% by mass or less, 6% by mass or less, 5.5% by mass or less, or 5% by mass or less.
[0040] In one embodiment, the salt-containing water may contain magnesium chloride. The content of magnesium chloride is not particularly limited, but is preferably 1% by mass or more, 0.15% by mass or more, 0.2% by mass or more, 0.25% by mass or more, or 0.3% by mass or more relative to the total amount of the salt-containing water. On the other hand, the content of magnesium chloride is preferably 1% by mass or less, 0.95% by mass or less, 0.9% by mass or less, 0.85% by mass or less, 0.8% by mass or less, 0.75% by mass or less, 0.7% by mass or less, 0.65% by mass or less, 0.6% by mass or less, 0.55% by mass or less, or 0.5% by mass or less.
[0041] In one embodiment, seawater can be used as the salt-containing water. Seawater contains appropriate amounts of sodium chloride, magnesium chloride, etc. For example, when boiled in tap water, water enters the mekabu from the cut end of the mekabu (when it is cut from the stem or cut to a certain size), diluting the minerals and other components, whereas boiling in seawater can prevent the minerals and other components from diluting.
[0042] The heating time (boiling time) is not particularly limited, but is preferably, for example, 30 seconds or more, 40 seconds or more. By having a boiling time longer than the required value, components that increase the bitterness, such as nitrate nitrogen, can be reduced. On the other hand, the heating time is not particularly limited, but is preferably 2 minutes or less, 1.5 minutes or less. By having a boiling time shorter than the required value, it is possible to prevent glutamic acid and water-soluble dietary fiber from flowing out into salt-containing water. The boiling time is the time until the mekabu turns green after boiling, and is not limited to this depending on the production area of the mekabu, etc.
[0043] The heating temperature (the temperature of the salt-containing water for boiling) is not particularly limited as long as it is 70° C. or higher and 100° C. or lower, but is preferably 75° C. or higher, 80° C. or higher, or 85° C. or higher. On the other hand, the heating temperature is preferably 98° C. or lower, or 95° C. or lower.
[0044] (cooling process) The cooling process involves immersing the boiled wakame in water at a temperature between 0°C and 40°C and cooling it.
[0045] The cooling time is not particularly limited, but is preferably 1 minute or more, 2 minutes or more, or 3 minutes or more. On the other hand, the heating time is not particularly limited, but is preferably 30 minutes or less, 25 minutes or less, 20 minutes or less, or 15 minutes or less. By keeping the cooling time to a required value or less, it is possible to suppress the outflow of glutamic acid and water-soluble dietary fiber into water.
[0046] The cooling temperature (the temperature of the water in which the Mekabu is soaked) is not particularly limited as long as it is from 0° C. to 40° C., and is preferably from 5° C. to 10° C. On the other hand, the cooling temperature is preferably 35° C. or less, 30° C. or less, 25° C. or less, or 15° C. or less.
[0047] The cooling may be carried out in a multi-stage process. In that case, the cooling temperature is the lowest temperature of the temperatures of the water used for cooling, and the cooling time is the time during which the temperature is maintained within the above-mentioned temperature range.
[0048] The water for cooling may be tap water, mineral water, or sea water. The water may be cooled.
[0049] (cutting process) The cutting process is a process in which the cooled wakame is cut into pieces with a width of 0.5 mm to 2 mm.
[0050] The dimensions of the wakame after cutting are as described above, so the description will be omitted here.
[0051] (Freezing process) Although not an essential step, the cooling step according to the present embodiment may include a freezing step, which is a step of freezing the cut wakame.
[0052] In addition, when the mekabu is frozen, the above-mentioned respective configurations (composition, physical properties) of the mekabu are the configurations that the mekabu has after thawing.
[0053] The freezing temperature in the freezing step is not particularly limited, and may be, for example, 0° C. or less, −5° C. or less, −10° C. or less, −15° C. or less, −20° C. or less, or −25° C. or less. On the other hand, the freezing temperature may be −100° C. or less, −95° C. or less, −90° C. or less, −85° C. or less, −80° C. or less, −75° C. or less, −70° C. or less, −65° C. or less, or −60° C. or less.
[0054] In this way, freezing the Mekabu can improve its storage stability. Note that the Mekabu frozen in this way can be thawed under running water or hot water.
[0055] <Benefits of bowel movements> The defecation improving agent according to this embodiment contains Mekabu, which contains 4.5% by mass or more of water-soluble dietary fiber.
[0056] The defecation improver according to this embodiment has the same components, physical properties, and intake amount as the pollen allergy suppressant described above, so the section on the pollen allergy suppressant can be cited. In this case, the "pollen allergy suppressant" shall be read as the "defecation improver".
[0057] <Skin disease improving agent> The skin disease ameliorating agent according to this embodiment contains Mekabu, which contains 4.5% by mass or more of water-soluble dietary fiber.
[0058] The skin disease improving agent according to this embodiment has the same components, physical properties, and intake amount as the above-mentioned pollen allergy suppressant, so the section on the pollen allergy suppressant can be cited. In this case, the "pollen allergy suppressant" is to be read as the "skin disease improving agent".
[0059] The pollen allergy suppressant, defecation improver, and skin disease improver of the present embodiment can be modified as appropriate within the scope that does not impair the effects of the present invention. EXAMPLES
[0060] The present invention will be described in more detail below with reference to examples, but the present invention is not limited to the following embodiments.
[0061] <Clinical Trials> [Sample preparation] Example 1: Test Food Mekabu cultivated in Kesennuma's inner bay was boiled in 90°C seawater until it turned green, then cooled in 20°C tap water for 10 minutes, cut into pieces 5-10 mm long and 1-2 mm wide, packed, and frozen. When ready to eat, it was thawed under running tap water.
[0062] (Comparative Example 1: Placebo) The tokoroten was frozen and thawed twice to remove a certain amount of water, then colored with green and red food colorings, packed in the same packs as in Example 1, and frozen. When eating, the tokoroten was thawed under running water.
[0063] 〔test〕 [Target audience] The subjects were selected from those who (1) understood the contents of the study and provided written consent, (2) were aged 20 years or older and under 65 years, (3) were considered to be in general health, (4) were able to consume the test foods every day during the study period, (5) had allergic symptoms, and (6) did not meet the exclusion criteria listed below.
[0064] (exclusion criteria) -Continuous intake of health foods, quasi-drugs, or medicines that claim or emphasize similar or related effects or efficacy to those examined in this study Those who have changed or started using a new health food within the past four weeks Those who work night shifts or day / night shifts - At the time of obtaining consent, individuals who are receiving treatment (hormone replacement therapy, drug therapy, exercise therapy, diet therapy) at a medical institution for the treatment or prevention of a disease, or who are judged to require treatment - Individuals who have a history of serious diseases of glucose metabolism, lipid metabolism, liver function, kidney function, heart, circulatory system, respiratory system, endocrine system, immune system, nervous system, or mental illness -Those with a history of alcohol or drug dependence Those who are at risk of developing food allergies -Those with thyroid problems -Persons who are pregnant or breastfeeding at the time of obtaining consent, or who wish to become pregnant during the study period -Those who have participated in other human trials (human trials using food, pharmaceuticals, quasi-drugs, medical devices, etc.) within the past 4 weeks, or who are scheduled to participate in other human trials during the planned period of this study. -Those who are judged by the study director to be inappropriate to participate in the study
[0065] [allocation] At the contracted testing organization, the allocation manager, who was not directly involved in the study, used a stratified randomization method based on BMI and age to allocate subjects to two groups: a test substance group taking the test substance and a placebo group taking a placebo. Blinding was performed on all people involved in the study, including the subjects, and the allocation manager kept the details of the blinding securely until the data was fixed.
[0066] [Test foods and interventions] The test food used was mekabu (seaweed) cultivated in an inland bay in Kesennuma, Miyagi Prefecture. The test food used 40g of seasoned mekabu (Example 1), and the placebo food used was one in which mekabu was replaced with tokoroten, so that the subjects could not distinguish between the two based on appearance, taste, or smell. The subjects consumed 40g of the test food or placebo food given to them per day for the intervention period of 4 weeks.
[0067] [Evaluation items and measurements] All items were measured by mail and were carried out by the subjects at home. Measurements were carried out twice, before and after ingestion, and evaluations of allergic rhinitis-like symptoms and bowel movements were carried out as follows.
[0068] [Evaluation of allergy-like symptoms] (Japan Standard Allergic Rhinitis QOL Questionnaire (JRQLQ)) The JRQLQ is used to investigate allergic rhinitis, and is composed of four items for nasal symptoms, two items for eye symptoms, as well as a QOL question and an overall state (face scale). QOL consists of 17 questions, and is divided into six areas: daily life, outdoor activities, social life, sleep, body, and mental life. A total QOL score is calculated by adding an evaluation of the overall state to this. A higher score indicates worse allergic rhinitis symptoms and QOL.
[0069] (Dermatology-specific Quality of Life Scale (DLQI)) The DLQI is a questionnaire that evaluates the quality of life (QOL) related to skin diseases and consists of 10 questions. It is evaluated in six scales, namely symptoms / emotions, daily activities, leisure, work / school, relationships, and treatment, as well as a total score. Higher scores indicate poorer QOL.
[0070] [Defecation evaluation] (Japanese version of the Constipation assessment scale (CAS)) The CAS is a questionnaire in which patients self-assess on a scale of 0 to 2 eight items related to bowel movements (feeling of abdominal bloating, amount of gas passed, frequency of stool, feeling of the rectum being full, pain in the anus during defecation, amount of stool, state of stool excretion, diarrhea or watery stool). The higher the score, the greater the tendency to constipation.
[0071] [Adverse events assessment] During the pre-measurement, the subjects' medical history and subjective symptoms were confirmed using a questionnaire. If there were any changes in their physical condition after the intervention, a system was established to promptly obtain this information.
[0072] [Statistical analysis] The measured values for the test substance group and placebo group were shown as the mean and standard error. Paired t-tests were used for before-and-after comparisons within groups, and independent t-tests were used for comparisons between groups. In addition, repeated measures analysis of variance was used to confirm interactions between the measurement time factor and group factor. The significance level was set at 5%, and differences less than 5% were considered to indicate significant differences. Free statistical analysis software HAD was used for statistical analysis.
[0073] [Test Results] [Target of analysis] Of the 30 participants (15 in the test substance group and 15 in the placebo group), one participant dropped out due to personal reasons and was excluded from the placebo group, leaving 15 participants in the test substance group (5 men, 10 women) and 14 participants in the placebo group (4 men, 10 women) for the analysis. The average age (± standard deviation) of the participants was 45.33 years ± 9.91 in the test substance group and 45.71 years ± 12.93 in the placebo group (Table 1). The intake rate calculated using the number of days and frequency of intake was 100% (n = 15) in the test substance group and 100% (n = 14) in the placebo group.
[0074] [Table 1]
[0075] [Evaluation of allergy-like symptoms] Table 2 shows the results of JRQLQ. Figure 1 shows the "sneezing" scores before and after intake for the test substance group and the placebo group. Figure 2 shows the "daily life" scores before and after intake for the test substance group and the placebo group. Figure 3 shows the "social life" scores before and after intake for the test substance group and the placebo group. Figure 4 shows the "sleep" scores before and after intake for the test substance group and the placebo group. Figure 5 shows the "mental life" scores before and after intake for the test substance group and the placebo group.
[0076] [Table 2]
[0077] In the symptom of "sneezing" and "sleep," the values of the test substance group were high before ingestion, so a significant tendency (p<0.1) was observed in the comparison between the test substance group and the placebo group before ingestion. After ingestion, the test substance group improved and the placebo group worsened, so no significant difference was observed in the comparison between the groups (see Figures 1 and 4). In a comparison before and after, only the test substance group showed a significant improvement in the area of "daily life" (p<0.05), and a significant tendency was observed in the areas of "social life" and "mental life" (p<0.1). Furthermore, a significant interaction was observed between the factors of the measurement time and the group in the area of "daily life" (p<0.05) (see Figures 2, 3, and 5). In the placebo group, no significant differences were observed before and after ingestion in any area.
[0078] The results of DLQI are shown in Table 3. Figure 6 shows the total scores of "DLQI" before and after the intake of the test substance group and the placebo group. Figure 7 shows the scores of "daily life" before and after the intake of the test substance group and the placebo group. Figure 8 shows the scores of "treatment" before and after the intake of the test substance group and the placebo group.
[0079] [Table 3]
[0080] In a before-and-after comparison, only in the test substance group, a significant improvement was seen in the "total score" (p<0.05), and a significant tendency for improvement was seen in the "daily activities" and "treatment" scales (p<0.1). (Figures 6, 7, and 8) In the placebo group, no significant differences were seen in any scale before and after intake. In a comparison between the groups, no significant differences were seen between the two groups.
[0081] [Defecation evaluation] The results of the Constipation Assessment Scale (CAS) are shown in Table 4. Also, Figure 9 shows the "CAS" scores before and after intake of the test substance group and the placebo group.
[0082] In a comparison before and after, a significant decrease in the "total score" was observed only in the test substance group (p<0.1). In addition, in a comparison between groups, a significant difference was observed in the "total score" after intake (p<0.1) (Figure 9).
[0083] [Table 4]
[0084] [Adverse events] No adverse events, whether or not related to the test article, were observed in this study.
[0085] [Consideration] This study was a placebo-controlled, double-blind, randomized, parallel-group comparative study conducted on healthy adults with allergic symptoms to verify the effect of taking Mekabu on allergic symptoms and bowel symptoms. As a result, in the JRQLQ, the test substance group had higher values for the symptoms of sneezing and the area of "sleep" before intake, so a significant difference was observed in the comparison between the test substance group and the placebo group before intake. After intake, the test substance group improved and the placebo group worsened, so no significant difference was observed in the comparison between the groups. This suggests that the intake of the test substance had a positive effect. In addition, in a comparison before and after, only the test substance group showed a significant improvement in the area of "daily life," and a significant improvement was observed in the areas of "social life" and "mental life." These results suggest that the intake of the test substance may improve the symptoms of allergic rhinitis and the quality of life (QOL) associated with it.
[0086] In the DLQI, which evaluates skin disease-related QOL, no significant differences were observed in any scale in the placebo group before and after comparison, whereas the test substance group showed a significant improvement in the "total score" and a significant tendency for improvement in the "daily activities" and "treatment" scales. This suggests the possibility that taking the test substance may improve skin disease-related QOL.
[0087] In the Constipation Assessment Scale (CAS), a significant improvement was seen in the "total score" before and after the study only in the test substance group. A significant difference was also seen in the comparison between the groups after ingestion. Considering that an increase in stool volume was also seen in the bowel movement VAS in the test substance group, it is suggested that ingestion of the test substance has the effect of increasing stool volume and improving constipation symptoms.
[0088] [Conclusion] This study confirmed that taking Mekabu seaweed improves the symptoms of allergic rhinitis and the associated quality of life (QOL), as well as constipation symptoms.
[0089] <Reference test: Analysis of composition and physical properties> [Sample preparation] Samples of Reference Examples 1 to 4 (commercially available Mekabu) were prepared by the methods described below.
[0090] [Reference examples 1~4] We prepared commercially available Mekabu as shown in Table 1 below.
[0091] [Evaluation method] The samples of Example 1 and Reference Examples 1 to 4 were evaluated by the methods described below. Each sample was measured 10 times (N=10) and the arithmetic average value was calculated.
[0092] [Measurement of breaking hardness] Measurement was performed by a breaking test using a rheometer. Specifically, for each sample of Example 1 and Reference Examples 1 to 4, one individual (one piece) was measured with a rheometer (IMADA DSV-50N-M4, wedge probe) to measure the load (N) when the piece broke.
[0093] [Measurement of water-soluble dietary fiber content] The amount of water-soluble dietary fiber was quantified according to the enzyme-HPLC method of the Nutrition Labeling Standard. Specifically, each sample of Example 1 and Reference Examples 1 to 4 was treated with three kinds of enzymes, and a four-fold amount of ethanol was added to cause precipitation, which was then suction filtered. Proteins, organic acids, and inorganic salts were removed from the filtrate using an ion exchange resin, and the fraction containing three or more sugars was measured by the HPLC method to quantify the amount of water-soluble dietary fiber.
[0094] [Measurement of nitrate nitrogen content] The amount of nitrate nitrogen was measured by an ion electrode method. Specifically, each sample of Example 1 and Reference Examples 1 to 4 was crushed and stirred with a homogenizer, filtered with a 0.45 μm disposable membrane filter unit, and the nitrate nitrogen concentration was measured using an ion electrode meter (HORIBA, LAQUAtwin NO3-11).
[0095] [Measurement of glutamic acid content] The amount of glutamic acid was measured by HPLC. Specifically, each sample of Example 1 and Reference Examples 1 to 4 was crushed and stirred with a homogenizer, filtered with a 0.45 μm disposable membrane filter unit, and the free glutamic acid content was quantified by HPLC analysis.
[0096] 〔result〕 The evaluation results are shown in Table 5. [Table 5]
Claims
1. Contains wakame seaweed containing 4.5% or more by mass of water-soluble dietary fiber Hay fever suppressant.
2. Intake of 30g to 200g per day in terms of Mekabu. The pollen allergy suppressant according to claim 1.
3. Contains wakame seaweed containing 4.5% or more by mass of water-soluble dietary fiber Bowel movement improver.
4. Intake of 30g to 200g per day in terms of Mekabu. The defecation improving agent according to claim 3.
5. Contains wakame seaweed containing 4.5% or more by mass of water-soluble dietary fiber Skin disease improving agent.
6. Intake of 30g to 200g per day in terms of Mekabu. The skin disease improving agent according to claim 5 .