WO2024080117A1 - Composition orale pour prévenir et/ou améliorer les symptômes du rhume - Google Patents

Composition orale pour prévenir et/ou améliorer les symptômes du rhume Download PDF

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WO2024080117A1
WO2024080117A1 PCT/JP2023/034691 JP2023034691W WO2024080117A1 WO 2024080117 A1 WO2024080117 A1 WO 2024080117A1 JP 2023034691 W JP2023034691 W JP 2023034691W WO 2024080117 A1 WO2024080117 A1 WO 2024080117A1
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group
test food
difference
groups
placebo group
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Japanese (ja)
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綾香 中島
健吾 鈴木
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株式会社ユーグレナ
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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/748—Cyanobacteria, i.e. blue-green bacteria or blue-green algae, e.g. spirulina
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/02—Nasal agents, e.g. decongestants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/04—Drugs for disorders of the respiratory system for throat disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/14—Antitussive agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Definitions

  • the present invention relates to an oral composition for preventing and/or improving cold symptoms.
  • Patent Document 1 describes a cold medicine composition that contains an antipyretic and analgesic drug such as ibuprofen.
  • Euglena is a single-celled microorganism classified as a microalgae. Because it has properties of both plants and animals, it contains a wide variety of nutrients, including vitamins, minerals, amino acids, and fatty acids. Since mass cultivation techniques for edible purposes were established in 2005, it has been used as a nutritional food and supplement to this day.
  • the object of the present invention is to provide an oral composition for preventing and/or improving cold symptoms.
  • an oral composition for preventing and/or ameliorating cold symptoms which contains a Euglena algae body substance.
  • the cold symptoms are preferably at least one selected from the group consisting of general malaise, chills, fever, fatigue, sneezing, runny nose, nasal congestion, sore throat, cough, joint pain, muscle pain, and headache.
  • the oral composition is preferably a food product.
  • the oral composition is preferably a beverage.
  • the oral composition may be a pharmaceutical product.
  • the present invention provides an oral composition for preventing and/or improving cold symptoms.
  • 1 is a graph showing the average cumulative number of days with cold symptoms over an 8-week period. Graph showing the mean severity of hot flashes over the entire period (8 weeks). Graph showing mean fatigue severity in the later period (last 4 weeks, periods V-VIII). 1 is a graph showing the mean severity of nasal congestion in the later period (last 4 weeks, periods V to VIII). Graph showing mean severity of sore throat in the later period (last 4 weeks, periods V-VIII). Graph showing the mean severity of muscle pain in the later period (last 4 weeks, periods V to VIII). 1 is a graph showing the change in the cumulative number of days with cold symptoms. 1 is a graph showing the change in cumulative number of fatigue days over time. 1 is a graph showing the total cumulative number of days of fatigue each week.
  • FIG. 13 is a diagram showing the cumulative percentage of each response regarding fatigue over the entire period (8 weeks).
  • FIG. 13 is a diagram showing the cumulative percentage of each response regarding sneezing over the entire period (8 weeks).
  • FIG. 13 is a graph showing the cumulative percentage of each response regarding nasal congestion over the entire period (8 weeks).
  • FIG. 13 is a diagram showing the cumulative percentage of each cough response over the entire period (8 weeks).
  • FIG. 13 is a diagram showing the cumulative percentage of each response regarding muscle pain over the entire period (8 weeks).
  • This embodiment relates to an oral composition for preventing and/or improving cold symptoms, and an agent for preventing and/or treating cold symptoms, which contains a substance derived from Euglena.
  • the preventive and/or therapeutic agent for cold symptoms according to this embodiment contains a Euglena-derived substance as an active ingredient and is used for preventing and/or treating cold symptoms.
  • Cold symptoms refers to at least one selected from the group consisting of general malaise, chills, fever, fatigue, sneezing, runny nose, nasal congestion, sore throat, cough, joint pain, muscle pain, and headache.
  • Prevention and/or treatment of cold symptoms refers to the concept of preventing, treating, alleviating, and improving cold symptoms.
  • the preventive and/or therapeutic agent for cold symptoms according to this embodiment can be used for at least one selected from the group consisting of relieving nasal discomfort, relieving runny nose, relieving nasal congestion, relieving itchy nose, relieving stuffy nose, relieving throat discomfort, relieving throat swelling, relieving redness in the throat, relieving a sore throat, relieving hoarseness, relieving phlegm, relieving chills, relieving tingling, relieving a feeling of sluggishness, relieving a feeling of hot flashes, relieving a feeling of daze, relieving a feeling of lethargy, relieving a feeling of lethargy, and relieving a feeling of fatigue.
  • the Euglena-derived substance includes dried Euglena algae, Euglena extract, and living Euglena cells, as well as paramylon extracted from Euglena cells, paramylon powder, and processed paramylon products.
  • Euglena includes microorganisms taxonomically classified in the genus Euglena, their variants, mutant species, and closely related species in the family Euglenaceae.
  • the genus Euglena refers to a group of organisms belonging to the Excavata, Euglenozoa, Euglenophyceae, Euglenales, and Euglenaceae families among eukaryotes.
  • Euglena chadefaudii Euglena deses, Euglena gracilis, Euglena granulata, Euglena mutabilis, Euglena proxima, Euglena spirogyra, and Euglena viridis.
  • Euglena Euglena gracilis
  • Euglena gracilis Z strain can be used, but other species such as Euglena gracilis Z strain mutant SM-ZK strain (chloroplast-deficient strain) and E. gracilis var. bacillaris variant, genetic mutants such as chloroplast mutants of these species, and other Euglena species such as Astasia longa can also be used.
  • the genus Euglena is widely distributed in freshwater such as ponds and swamps, and may be isolated from these for use, or any Euglena species that has already been isolated may be used.
  • the genus Euglena includes all mutant strains. These mutant strains also include those obtained by genetic methods such as recombination, transduction, transformation, etc.
  • Euglena algae bodies can be used as Euglena.
  • Euglena live cells separated by centrifugation, filtration, sedimentation, or the like can be used as they are as Euglena algae bodies.
  • Euglena live cells can be used as they are after harvesting from the culture tank, but it is preferable to wash them with water or physiological saline.
  • Euglena algae bodies may also be used in the form of a dispersion in which the Euglena algae bodies are dispersed in a liquid such as water.
  • mechanically treated algae bodies obtained by subjecting living Euglena cells to ultrasonic irradiation or mechanical treatment such as homogenization may be used as the Euglena algae bodies.
  • the mechanically treated product may be dried and used as the Euglena algae bodies.
  • defatted Euglena powder obtained by degreasing Euglena algae bodies for example, with a non-polar solvent.
  • a Euglena extract (Euglena extract) can be used as Euglena, and it is particularly preferable to use a Euglena aqueous solvent extract.
  • Euglena aqueous solvent extract refers to an extract extracted from Euglena using an aqueous solvent, and it is particularly preferable to use a water extract, hot water extract, alcohol extract, or glycol extract of Euglena extracted using water, alcohols, or glycols as the aqueous solvent at 5°C to 600°C for several seconds to several tens of hours.
  • the water used for extraction does not necessarily have to be distilled water, pure water, or ultrapure water, and may be, for example, tap water or water containing impurities, but water that does not contain components that interfere with the extraction of active ingredients is preferable.
  • water extract refers to an extract using water at 0 to 50°C (excluding 0°C).
  • water refers to water at 0 to 50°C (excluding 0°C).
  • the temperature of the water is not particularly limited as long as it is within a range in which the active ingredients can be sufficiently extracted without affecting them, but is preferably 1 to 40°C, more preferably 5 to 35°C, and particularly preferably 10 to 30°C.
  • hot water extract refers to an extract using water at a temperature higher than 50°C, and can also be called “warm water extract.”
  • hot water refers to water at a temperature higher than 50°C, and is a concept that includes “hot water,” including water in a boiling state. It is also not limited to hot water in a liquid state, but also includes hot water in a gaseous state and a supercritical state.
  • the temperature of the hot water is not particularly limited as long as it is within a range that can sufficiently extract the active ingredients without affecting them, but is preferably higher than 50°C and lower than 120°C, and more preferably higher than 50°C and lower than 100°C.
  • the pH of the water used for extraction is not particularly limited as long as it is within a range that allows the active ingredients to be sufficiently extracted without affecting them, but a pH of 4 to 10 is preferable, a pH of 5 to 9 is more preferable, and a pH of 6 to 8 is particularly preferable.
  • the aqueous solvent can be one that can sufficiently extract the active ingredient without affecting the active ingredient, and one or more solvents that can be normally used for extraction can be selected and used.
  • solvents that can be normally used for extraction
  • examples include water, alcohols, glycols, etc., but are not limited to these.
  • alcohols include ethanol, methanol, n-propanol, isopropanol, etc.
  • glycols include butylene glycol (BG) and propylene glycol, etc.
  • Other aqueous solvents include acetone, etc. These solvents can be used alone or as an aqueous solution, or as a mixed solvent of any two or more kinds.
  • the temperature of the aqueous solvent used for extraction is, for example, 0°C or higher, and is not particularly limited as long as it does not affect the active ingredients.
  • an aqueous solvent in a boiling or supercritical state can also be used, it is preferable to use an aqueous solvent at 5°C to 600°C, and it is more preferable to use an aqueous solvent at 10°C to 200°C. Therefore, aqueous solvents for extraction include aqueous solvents in a boiling or supercritical state.
  • the amount of aqueous solvent used for extraction is preferably an amount that can fully dissolve the water-soluble active ingredients contained in Euglena.
  • the extraction method is not particularly limited, and for example, extraction can be performed by the method shown below, but ordinary extraction methods can be freely selected and used without being limited thereto. Examples include a method in which dry powder of Euglena algae is soaked in an aqueous solvent for a predetermined time, followed by centrifugation or filtration, and a method in which dry powder of Euglena algae is added to an aqueous solvent, shaken to disperse uniformly, and then centrifuged or filtered. In addition, to promote extraction, it is also possible to heat the aqueous solvent after adding Euglena.
  • Water extraction of Euglena can be performed by a conventional method such as those shown below, but is not limited thereto.
  • Euglena tissue and water are placed in a container, and the container is left to stand for a predetermined time while being appropriately stirred or shaken.
  • the obtained extract can be used as it is as a water extract.
  • the supernatant obtained by centrifuging such an extract can also be used as a water extract.
  • the extract or supernatant can also be concentrated and dried to remove water, and used as a water extract.
  • Water extraction can be performed by adding a small amount of alcohol, for example, 10% by mass or less, preferably ethanol, to water in order to increase the extraction efficiency and shorten the extraction time.
  • the extraction time when performing water extraction is not particularly limited as long as it is a time that allows the active ingredient to be extracted, and can be set appropriately in the range of several seconds to several tens of hours depending on the extraction temperature.
  • Extraction using hot water can be performed by a commonly used method such as, but not limited to, the following.
  • Euglena is introduced into a commonly used extractor together with water, and then heated to perform extraction.
  • the pressure during extraction can be set to 1 to 5,000 atmospheres, and is preferably set to 60 to 400 atmospheres.
  • the extraction time is kept short, for example, within 3 minutes, more preferably within 1 minute, and especially preferably within 30 seconds.
  • the extracted Euglena extract can be used as it is as an active ingredient of the agent for preventing and/or treating cold symptoms according to this embodiment, but the extract can also be further fractionated by appropriate separation means (e.g., partition extraction, gel filtration, silica gel chromatography, reverse-phase or normal-phase high-performance liquid chromatography, etc.) to obtain highly active fractions for use.
  • the Euglena extract or a fraction thereof can be concentrated and dried to remove the aqueous solvent, and used as an aqueous solvent extract.
  • the Euglena extract may be a water-soluble component extracted by enzymatic proteolysis of algae cells belonging to the genus Euglena, specifically, a hydrolyzed Euglena extract obtained by enzymatic hydrolysis of Euglena powder (Euglena algae).
  • the hydrolyzed Euglena extract may be prepared according to the method described in JP 2010-90065 A.
  • the method for preparing hydrolyzed Euglena extract is explained below.
  • Purified water is added to the dried Euglena (weight), preferably in an amount 100 times (weight), and the mixture is subjected to a pressurized heat treatment.
  • a proteolytic enzyme is then added to treat the algae. After the treatment is complete, the mixture is inactivated, for example, at 90°C, and the residue is separated from the water-soluble components by centrifugation or filtration.
  • the conditions for the pressurized heat treatment are preferably heating and pressurizing at 100-150°C, atmospheric pressure to 0.255 MPa, and 1-30 minutes using an autoclave, for example, heating and pressurizing at 0.1-0.14 MPa and 121°C for 10 minutes.
  • the proteolytic enzyme for example, commonly used enzymes with protease activity such as pepsin, pancreatin, and papain may be used alone or in combination, and it is particularly preferable to use an endopeptidase to hydrolyze peptide bonds in the middle of the polypeptide chain and break it down into several peptides.
  • proteolytic enzymes that can be used include Yakult Pharmaceutical Co., Ltd.'s Panchidase MP and Aroase AP-10.
  • concentration of the enzyme to be added, the pH of the reaction solution, the reaction temperature, and other conditions can be selected to be optimal for each enzyme preparation.
  • the water-soluble component thus obtained can be used as is, but it can also be used after undergoing purification procedures such as fractionation, deodorization, decolorization, and concentration, within the scope that does not impair the effects of the present invention.
  • Polysaccharide contained in the genus Euglena, which is a polymer ( ⁇ -1,3-glucan) in which approximately 700 glucose molecules are polymerized through ⁇ -1,3-bonds.
  • Paramylon particles are flat spheroidal particles formed by entangling ⁇ -1,3-glucan chains in a spiral shape.
  • Paramylon exists as granules in the cells of all species and varieties of Euglena, and the number, shape, and uniformity of the particles vary depending on the species.
  • Paramylon consists only of glucose, and the average degree of polymerization of paramylon obtained from the wild strain of E. gracilis Z and the chloroplast-deficient strain SM-ZK is approximately 700 glucose units.
  • Paramylon is insoluble in water and hot water, but is soluble in dilute alkali, concentrated acid, dimethyl sulfoxide, formaldehyde, and formic acid.
  • the average density of paramylon is 1.53 in E. gracilis Z and 1.63 in E. gracilis var. bacillaris SM-L1.
  • paramylon has a loose spiral structure in which three linear ⁇ -1,3-glucans are twisted together like a right-handed rope. Several of these glucan molecules come together to form paramylon granules. Paramylon granules have a very high crystalline structure, accounting for approximately 90%, making it the compound with the highest crystalline structure rate among polysaccharides.
  • the particle size distribution of paramylon (manufactured by Euglena Co., Ltd.) has a median diameter of 1.5 to 2.5 ⁇ m when measured using a laser diffraction/scattering particle size distribution measuring device.
  • Paramylon particles are isolated from cultured Euglena cells by any suitable method, purified into fine particles, and usually provided as a powder.
  • paramylon particles can be obtained by (1) culturing Euglena cells in any suitable medium, (2) isolating Euglena cells from the medium, (3) isolating paramylon from the isolated Euglena cells, (4) purifying the isolated paramylon, and, if necessary, (5) cooling and subsequent freeze-drying.
  • Paramylon is isolated, for example, using a nonionic or anionic surfactant of a type that is largely biodegradable. Paramylon is purified substantially simultaneously with the isolation.
  • Processed paramylon products include water-soluble paramylon obtained by chemically or physically treating paramylon using various known methods, sulfated paramylon, and paramylon derivatives.
  • Processed paramylon products include, for example, amorphous paramylon and emulsion paramylon.
  • Amorphous paramylon is a substance in which crystalline paramylon derived from Euglena has been made amorphous.
  • Amorphous paramylon has a relative crystallinity of 1-20% compared to crystalline paramylon produced from Euglena by known methods. However, this relative crystallinity was determined by the method described in JP 2011-184592 A.
  • Amorphous paramylon is prepared according to the method described in JP 2011-184592 A by treating crystalline paramylon powder with an alkali, neutralizing it with acid, washing, removing moisture, and then drying.
  • Paramylon processed products also include water-soluble paramylon, obtained by chemically or physically processing paramylon using various known methods, sulfated paramylon, and paramylon derivatives.
  • Emsision paramylon is a substance also known as emulsion paramylon because its processing method and physical properties are similar to those of an emulsion. It is obtained by adding water to paramylon and carrying out a collision process in which the resulting fluid is ejected from a fine nozzle at ultra-high pressure and collided with an object to be impacted, according to the method described in JP 2016-199650 A, and is processed paramylon that has combined with more than four times its amount of water and swelled.
  • Emulsion paramylon can be obtained by performing a collision process at least once using a known property modification device (such as the device described in JP 2011-88108 A and JP 6-47264 A) in which a slurry of a powder or other solid with a water-soluble solvent is sprayed at ultra-high pressure from a fine nozzle and collided with a collision target, with a nozzle pressure of 245 MPa during spraying.
  • a known property modification device such as the device described in JP 2011-88108 A and JP 6-47264 A
  • a slurry of a powder or other solid with a water-soluble solvent is sprayed at ultra-high pressure from a fine nozzle and collided with a collision target, with a nozzle pressure of 245 MPa during spraying.
  • the median diameter is more than 7 ⁇ m, which is more than five times that of paramylon, and when observed using an optical electron microscope, the particles are observed to be attached to adjacent particles, and they swell by combining with more than four times as much water as paramylon.
  • the slurry made by mixing raw paramylon with water is a smooth fluid, but in emulsion paramylon, the paramylon disperses in the water molecules, increasing its viscosity and giving it a sticky, elastic texture that sticks to your hand when you touch it, like glue.
  • the processed paramylon obtained is called emulsion paramylon based on its processing method and physical properties, but it is unclear whether it is emulsified or not, and the paramylon is in a swollen state due to binding with water.
  • the preventive and/or therapeutic agent for cold symptoms is configured as an oral composition, for example, a food composition such as a health food or a pharmaceutical composition, and is used, ingested, or administered prophylactically and/or therapeutically to prevent and/or treat cold symptoms.
  • a food composition such as a health food or a pharmaceutical composition
  • the Euglena-derived substance can be ingested as a food and has no side effects, so it can be used, ingested, or administered continuously.
  • the agent for preventing and/or treating cold symptoms of this embodiment can provide a food composition having said effect by blending an effective amount of a Euglena-derived substance capable of effectively exerting a preventive and/or therapeutic effect on cold symptoms as a food ingredient into various foods. That is, in the field of food, the present invention can provide a food composition of a food labeled for anti-aging or the like. Examples of such food compositions include general foods, foods for specified health uses, foods with nutrient functions, foods with functional claims, foods for hospital patients, supplements, and the like. The food composition can also be used as a food additive.
  • Such food compositions include seasonings, processed meat products, processed agricultural products, beverages (lactic acid bacteria beverages, soft drinks, alcoholic beverages, carbonated beverages, dairy beverages, fruit juice beverages, tea, coffee, nutritional drinks, etc.), powdered beverages (powdered juice, powdered soup, etc.), concentrated beverages, confectioneries (candy (throat lozenges), cookies, biscuits, gum, gummies, chewables, tablets, chocolate, etc.), bread, cereals, etc.
  • the foods may be in the form of capsules, lozenges, syrup, granules, powder, etc.
  • a "specified health food” is a food that contains functional ingredients that affect physiological functions, etc., and can be labeled as suitable for a specific health purpose with the permission of the Commissioner of the Consumer Affairs Agency. In the present invention, it is a food that is sold with a label indicating a specific health purpose related to anti-aging.
  • Foods with nutrient functions are foods that are used to supplement nutritional components (vitamins, minerals) and display the function of the nutritional components. To be sold as such, the amount of nutritional components contained in the recommended daily intake must be within the range of set upper and lower limits, and in addition to displaying the nutritional functions, warning labels must also be included.
  • Foods with functional claims are foods that display functionality based on scientific evidence at the responsibility of the business operator. Information on safety and the basis for functionality is submitted to the Commissioner of the Consumer Affairs Agency before sale.
  • the food composition according to this embodiment can contain one or more freely selected ingredients that can be used in regular food compositions.
  • all additives that can be used regularly in the food industry such as various seasonings, preservatives, emulsifiers, stabilizers, flavorings, colorants, preservatives, and pH adjusters, can be included.
  • the agent for preventing and/or treating cold symptoms of this embodiment is a pharmaceutical composition having said effect, which can be provided by combining an amount of a Euglena-derived substance capable of effectively exerting an effect of preventing and/or treating cold symptoms with pharma- ceutical carriers and additives.
  • the pharmaceutical composition may be a drug or a quasi-drug.
  • the pharmaceutical composition is preferably applied internally (particularly orally), but may also be applied externally. Therefore, the pharmaceutical composition can be used in the form of an oral preparation, an injection such as an intravenous injection, a subcutaneous injection, an intradermal injection, an intramuscular injection and/or an intraperitoneal injection, a transmucosal application preparation, a transdermal application preparation, etc.
  • the dosage form of the pharmaceutical composition can be appropriately set depending on the form of application, and examples include solid preparations such as tablets, granules, capsules, powders, and dustings, liquid preparations such as solutions and suspensions, semi-solid preparations such as ointments or gels.
  • the pharmaceutical composition according to this embodiment can contain one or more pharma- ceutically acceptable additives of your choice.
  • the pharmaceutical composition according to this embodiment when applied to an oral preparation, it can contain all additives that are typically used in the field of pharmaceutical preparations, such as excipients, binders, disintegrants, surfactants, preservatives, colorants, flavorings, fragrances, stabilizers, preservatives, antioxidants, etc.
  • it can also be made into a sustained-release preparation by utilizing a drug delivery system (DDS).
  • DDS drug delivery system
  • the method of use of the preventive and/or therapeutic agent for cold symptoms and the food composition for preventing and/or improving cold symptoms of this embodiment may be, for example, orally administered in the form of capsules, powders, tablets, granules, liquids, syrups, etc.
  • the dosage and administration form of the preventive and/or therapeutic agent for cold symptoms and the food composition for preventing and/or improving cold symptoms of this embodiment may be appropriately selected depending on the subject, the disease state and its progression, and other conditions.
  • the Euglena-derived substance when orally administering to humans (adults) for the purpose of preventing and/or treating cold symptoms, is generally administered at a dose of 10 to 5,000 mg, preferably 500 to 5,000 mg, and more preferably 1,000 to 5,000 mg of Euglena per day in dry weight.
  • the frequency of administration is preferably several times a week, once every two days, once a day, or more, more preferably two or more times a day, and even more preferably three times a day, preferably in the morning, midday, and evening, specifically after each meal (after breakfast, lunch, and dinner).
  • the administration should be long-term or sustained, for example, for a period of 5 weeks or more, preferably 8 weeks or more.
  • Euglena algae it is preferable to ingest 500 mg or more of Euglena algae as a Euglena-derived substance per day for at least five weeks.
  • Test food compositions of Example 1 (test food group) and Comparative Example 1 (placebo group) are shown in the following Tables 1 and 2.
  • Euglena gracilis powder Euglena algae, manufactured by Euglena Co., Ltd. was used as Euglena.
  • test food composition was in the form of a hard capsule and packaged in an aluminum pouch. After opening the package, it was stored in the refrigerator.
  • ⁇ Test Effect of Euglena intake on the occurrence of cold symptoms> Men and women in their 20s to 80s were asked to continue taking capsules containing 1,000 mg of Euglena per day (test food group) or placebo capsules (placebo group) for eight weeks, and the presence or absence of cold symptoms was recorded daily.
  • the test was a double-blind study. Participants were asked to answer questions about cold symptoms, including 1. "general malaise,” 2. “chills,” 3. “feeling feverish,” 4. “fatigue,” 5. “sneezing,” 6. “runny nose,” 7. “nasal congestion,” 8. “sore throat,” 9. “cough,” 10. "joint pain,” 11. “muscle pain,” and 12. "headache,” on a five-point scale from 1 to 5 (1. “not at all,” 2. “hardly any,” 3. “a little,” 4. “somewhat,” 5. “severe”). Participants were judged to have developed symptoms if they answered 3 to 5, and the cumulative number of days each symptom developed and the maximum duration during the intake period were recorded.
  • the presence of one or more of the following symptoms was defined as cold symptoms: general malaise, chills, fever, fatigue, sneezing, runny nose, nasal congestion, sore throat, cough, joint pain, muscle pain, or headache.
  • the day on which a response other than 1 or 2 was given on or after the second day after response 1 was defined as the onset date of said symptom or cold symptoms (if a response other than 1 or 2 was given on the first or second day after starting intake, that day was also included in the onset date).
  • the cumulative number of days with cold symptoms, maximum duration, severity, number of cases, cumulative number of days with onset, etc. were recorded.
  • Period I The period from the start of intake to the 7th day of intake will be Period I
  • the period from the 8th to the 14th day will be Period II
  • each subsequent period will be determined as one week apart, with the final week (from the 50th to the 56th day of intake) being Period VIII.
  • the cumulative number of days with cold symptoms (average) from weeks 5 to 8 was significantly less in the Euglena intake group than in the placebo intake group. More specifically, as shown in Figures 2A to 2E, the average severity of feverishness and fatigue over the entire period (8 weeks) was significantly lower in the Euglena intake group than in the placebo intake group, and the average severity of nasal congestion, sore throat, and muscle pain in the later period (last 4 weeks) was significantly lower.
  • Proportion of cough severity level 1 Among the periods in which significant differences were observed, the periods in which the test food group showed higher values than the placebo group were the entire period (placebo group: 82.7%, test food group: 88.8%, difference between groups: 6.1% [4.8, 7.3], P ⁇ 0.001), the early period (placebo group: 82.6%, test food group: 88.2%, difference between groups: 5.6% [3.8, 7.4], P ⁇ 0.001), and the late period (placebo group: 82.8%, test food group: 89.4%, difference between groups: 6.6% [4.9, 8.4], P ⁇ 0.001).
  • the primary outcome of this study was the mean and standard deviation of the cumulative number of days with cold symptoms for each participant over the entire period: 15.9 ⁇ 17.5 days for the test food group and 21.3 ⁇ 19.2 days for the placebo group.
  • the difference between the groups and its 95% confidence interval was -5.4 days [-10.4, -0.5], meaning that the cumulative number of days with cold symptoms was significantly less in the test food group than in the placebo group.
  • the cumulative number of days with cold symptoms in the test food group was significantly lower than in the placebo group throughout the entire period and in the early and late periods, and the cumulative number of days with each of the following symptoms was also significantly lower in the test food group: general malaise, chills, fatigue, sneezing, runny nose, nasal congestion, sore throat, cough, and muscle pain.

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Abstract

L'invention concerne une composition orale pour prévenir et/ou améliorer les symptômes du rhume.　Cette composition orale pour prévenir et/ou améliorer les symptômes du rhume contient des algues euglena. Dans ce cas, il est préférable que les symptômes du rhume soient un ou plusieurs symptômes choisis dans le groupe constitué par le malaise général, les frissons, la fièvre, la fatigue, les éternuements, l'écoulement nasal, la congestion nasale, les maux de gorge, la toux, les douleurs articulaires, les myalgies et les maux de tête. Il est préférable que la consommation orale soit un produit alimentaire, une boisson ou un médicament.
PCT/JP2023/034691 2022-10-13 2023-09-25 Composition orale pour prévenir et/ou améliorer les symptômes du rhume WO2024080117A1 (fr)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015156339A1 (fr) * 2014-04-08 2015-10-15 株式会社ユーグレナ Agent d'ajustement de l'équilibre immunitaire
WO2019108319A1 (fr) * 2017-12-01 2019-06-06 Kemin Industries, Inc. Compositions contenant de l'euglena gracilis en vue d'une protection contre les virus et méthodes associées

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015156339A1 (fr) * 2014-04-08 2015-10-15 株式会社ユーグレナ Agent d'ajustement de l'équilibre immunitaire
WO2019108319A1 (fr) * 2017-12-01 2019-06-06 Kemin Industries, Inc. Compositions contenant de l'euglena gracilis en vue d'une protection contre les virus et méthodes associées

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
ANONYMOUS: "The Definitive Midorimushi Dictionary", MIDORIMUSHI, 18 August 2022 (2022-08-18), XP093159542, Retrieved from the Internet <URL:https://midorimushi-family.jp/blog/2015/02/2108.html> *
ANONYMOUS: "The Virtues of Euglena", CADC-ALBUFEIRA, 7 October 2022 (2022-10-07), XP093159539, Retrieved from the Internet <URL:https://www.cadc-albufeira.org/management-blog/116.html> *
ANONYMOUS: "What is the relationship between immunity and Euglena? Explaining the causes of weakened immunity and how to improve it!", EUGLENA - HEALTH COLUMN, EUGLENA HEALTHCARE LAB., pages 1 - 9, XP009555441, Retrieved from the Internet <URL:https://www.euglab.jp/column/euglena_clm/000459.html> *
EUGLENA: "Continuous intake of microalgae Euglena maintain and adjust immunity Human clinical trials have confirmed that it suppresses the occurrence of cold symptoms (cold-like symptoms) and the severity of various symptoms. ", EUGLENA - PRESS RELEASE, 1 November 2022 (2022-11-01), XP093159545, Retrieved from the Internet <URL:https://euglena.jp/news/20221101-2/> *
KAWANO TAKANORI; MIURA ATSUSHI; NAITO JUNKO; NISHIDA NORIHISA; ISHIBASHI KEN-ICHI; ADACHI YOSHIYUKI; OHNO NAOHITO; NAITO YUJI: "High-parameter immune profiling and subjective health assessment of the immunomodulatory effects of paramylon-rich Euglena gracilis EOD-1: A randomized, double-blind, placebo-controlled, parallel-group study", JOURNAL OF FUNCTIONAL FOODS, ELSEVIER BV, NL, vol. 109, 23 September 2023 (2023-09-23), NL , XP087415353, ISSN: 1756-4646, DOI: 10.1016/j.jff.2023.105804 *

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