Composition for alleviating or preventing symptoms of allergic rhinitis or allergic conjunctivitis

Abstract

The present invention provides a composition for alleviating or preventing symptoms of allergic rhinitis or allergic conjunctivitis, which contains dihomo-gamma-linolenic acid (DGLA) as an active ingredient.

Description

Technical Field

[0001] The present invention relates to a composition for alleviating or preventing the symptoms of allergic rhinitis or allergic conjunctivitis, etc. Background Art

[0002] Second High γ -linolenic acid (8,11,14-eicosatrienoic acid; DGLA) is an n-6 polyunsaturated fatty acid contained in breast milk, fish oil, seaweed, meat, etc. γ -linolenic acid synthesis. DGLA is known to exist in biological membranes and blood like other fatty acids, and is known to constitute 1 to 3% of biological membranes in the liver, spleen, epidermis, etc.

[0003] Known as a precursor of DGLA γ - Linolenic acid exhibits anti-inflammatory effects when administered orally. Its mechanism is believed to be as follows: γ -linolenic acid is converted into DGLA, which is then metabolized by cyclooxygenase to produce prostaglandin E1 (PGE1) to antagonize prostaglandin E2, or DGLA is metabolized by 15-lipoxygenase to produce 15-hydroxyeicosatrienoic acid (15-HETrE) to inhibit 5-lipoxygenase.

[0004] Regarding DGLA, a production technology from microorganisms has been discovered (Patent Document 1).

[0005] Regarding the physiological activity of DGLA, Patent Document 2 reports that the intake of DGLA in dermatitis model animals inhibits dermatitis. Patent Document 3 records that in an experiment using atopic dermatitis model mice, the intake of triglycerides whose main fatty acid composition is DGLA showed a tendency to inhibit the increase in the number of mast cells in skin lesions. Although Patent Document 4 does not show an example of the use of DGLA, it records that in an experiment using atopic dermatitis model mice, oral administration of DGLA inhibited the increase in the number of mast cells in skin lesions. γ -linolenic acid (GLA) ethyl ester inhibited high IgE production, and in an in vitro experiment using spleen cells from this model mouse, GLA inhibited IgE production. On the other hand, Patent Document 4 also states that even if GLA was orally administered to atopic dermatitis mice with hyper-IgEemia for 2 months, no inhibition of IgE production was confirmed.

[0006] Prior art literature Patent Literature Patent Document 1: Japanese Patent No. 3354581 Patent Document 2: WO2006 / 085687 Patent Document 3: Japanese Patent Application Laid-Open No. 2006-306813 Patent Document 4: Japanese Patent Laid-Open No. 2002-47176 Summary of the Invention Technical Problem to be Solved by the Invention So far, it has been reported that the intake of DGLA can suppress atopic dermatitis in mice. However, there is no report confirming the effect of DGLA intake on other allergic diseases.

[0007] In Patent Documents 2 and 3, it is described that in an experiment using atopic dermatitis model mice, a tendency was observed in which the increase in the number of mast cells in the skin lesion part was suppressed by the intake of DGLA. However, there is a report that the number of mast cells does not necessarily increase in cedar pollinosis patients (for example, Journal of the Otolaryngological Society of Japan, Vol. 87, No. 2, 1984, p. 141-148). Therefore, there is no common technical knowledge that if the increase in the number of mast cells is suppressed, the symptoms of allergic rhinitis or allergic conjunctivitis such as pollinosis can be alleviated or prevented.

[0008] An object of the present invention is to provide a novel means for alleviating or preventing the symptoms of allergic rhinitis or allergic conjunctivitis.

[0009] Technical Solution for Solving the Technical Problem The present inventors have found that during the period when cedar or cypress pollen scatters, for subjects who have had nose or eye discomfort, that is, the symptoms of allergic rhinitis or allergic conjunctivitis, in the past two years, the severity of the symptoms is reduced by the intake of DGLA. Further, it has been found that in subjects who have the symptoms of allergic rhinitis or allergic conjunctivitis at the initial stage of the scattering of pollen as an allergen, that is, subjects who are more sensitive to the allergen, the effect of DGLA intake in alleviating the severity of the symptoms is higher.

[0010] Based on the above insights, the present inventors have further conducted repeated studies and thus completed the present invention.

[0011] That is, the present invention is as follows.

[0012] [1] A composition for alleviating or preventing the symptoms of allergic rhinitis or allergic conjunctivitis, which contains dihomo- γ -γ-linolenic acid (DGLA) as an active ingredient.

[0013] [2] The composition according to [1], wherein the allergic rhinitis or allergic conjunctivitis is pollinosis.

[0014] [3] The composition according to [2], wherein the composition is used in a manner of oral administration to a subject who has the symptoms of allergic rhinitis or allergic conjunctivitis at the initial stage of the scattering of pollen.

[0015] [4] The composition according to [3], wherein, in the subject, the score of at least one selected from the severity classifications of allergic rhinitis symptoms, such as sneezing attacks, runny nose, nasal congestion, itchy eyes, and tearing, is 1 or more at the initial stage of pollen scattering.

[0016] [5] The composition according to [3], wherein, in the subject, the score of at least one selected from runny nose, sneezing, nasal congestion, itchy nose, itchy eyes, and tearing in the Japanese Allergic Rhinitis QOL questionnaire is 1 or more at the initial stage of pollen scattering.

[0017] [6] The composition according to [3], wherein the subject has a serum Japanese cedar pollen-specific IgE concentration of 0.73 UA / mL or less.

[0018] [7] The composition according to any one of [1] to [6], wherein the symptom is at least one selected from sneezing attacks, runny nose, nasal congestion, itchy nose, itchy eyes, and tearing.

[0019] [8] The composition according to [7], wherein the symptom is at least one selected from sneezing attacks, runny nose, itchy eyes, and tearing.

[0020] [9] The composition according to any one of [1] to [8], wherein the composition is used in a manner of orally administering 4 mg / kg body weight / day or more of DGLA to the subject.

[0021]

[10] The composition according to any one of [1] to [9], wherein DGLA is in any form of glyceride, phospholipid, glycolipid, alkyl ester, salt, or free fatty acid.

[0022]

[11] The composition according to

[10] , wherein the glyceride is triglyceride, diglyceride, or monoglyceride.

[0023]

[12] The composition according to

[10] , wherein the alkyl ester is an ester with a lower alcohol having 1 to 4 carbon atoms.

[0024]

[13] The composition according to

[10] , wherein the phospholipid is diacylglycerol phospholipid or lysophosphatidylglycerol.

[0025]

[14] A method for alleviating or preventing symptoms of allergic rhinitis or allergic conjunctivitis, wherein the method comprises administering to a subject an effective amount of a composition comprising dihomo- γ -γ-linolenic acid (DGLA) as an active ingredient.

[0026]

[15] The method according to

[14] , wherein the allergic rhinitis or allergic conjunctivitis is pollinosis.

[0027]

[16] The method according to

[15] , wherein the subject is a subject having symptoms of allergic rhinitis or allergic conjunctivitis at the initial stage of pollen dispersal.

[0028]

[17] The method according to

[16] , wherein in the subject, the score of at least one selected from the severity classifications of allergic rhinitis symptoms, such as sneezing attacks, runny nose, nasal congestion, itchy eyes, and tearing, is 1 or more at the initial stage of pollen dispersal.

[0029]

[18] The method according to

[15] , wherein in the subject, the score of at least one selected from runny nose, sneezing, nasal congestion, itchy nose, itchy eyes, and tearing in the Japanese Allergic Rhinitis QOL questionnaire is 1 or more at the initial stage of pollen dispersal.

[0030]

[19] The method according to

[16] , wherein the subject has a serum hinoki pollen-specific IgE concentration of 0.73 UA / mL or less.

[0031]

[20] The method according to any one of

[14] to

[19] , wherein the symptom is at least one selected from sneezing attacks, runny nose, nasal congestion, itchy nose, itchy eyes, and tearing.

[0032]

[21] The method according to

[20] , wherein the symptom is at least one selected from sneezing attacks, runny nose, itchy eyes, and tearing.

[0033]

[22] The method according to any one of

[14] to

[21] , wherein the subject ingests 4 mg / kg body weight / day or more of DGLA.

[0034]

[23] The method according to any one of

[14] to

[22] , wherein DGLA is in any form of glyceride, phospholipid, glycolipid, alkyl ester, salt, or free fatty acid.

[0035]

[24] The method according to

[23] , wherein the glyceride is triglyceride, diglyceride, or monoglyceride.

[0036]

[25] The method according to

[23] , wherein the alkyl ester is an ester with a lower alcohol having 1 to 4 carbon atoms.

[0037]

[26] The method according to

[23] , wherein the phospholipid is diacylglycerol phospholipid or lysophosphatidylglycerol.

[0038]

[27] A composition for alleviating or preventing symptoms of allergic rhinitis or allergic conjunctivitis, the composition comprising dihomo- γ -γ-linolenic acid (DGLA) as an active ingredient.

[0039]

[28] The composition according to

[27] , wherein the allergic rhinitis or allergic conjunctivitis is pollinosis.

[0040]

[29] The composition according to

[28] , wherein the composition is used in a manner of oral administration to a subject having symptoms of allergic rhinitis or allergic conjunctivitis at the initial stage of pollen scattering.

[0041]

[30] The composition according to

[29] , wherein in the subject, the score of at least one selected from the severity classifications of allergic rhinitis symptoms, such as sneezing attacks, runny nose, nasal congestion, itchy eyes, and tearing, is 1 or more at the initial stage of pollen scattering.

[0042]

[31] The composition according to

[29] , wherein in the subject, the score of at least one selected from runny nose, sneezing, nasal congestion, itchy nose, itchy eyes, and tearing in the Japanese Allergic Rhinitis QOL Questionnaire is 1 or more at the initial stage of pollen scattering.

[0043]

[32] The composition according to

[29] , wherein the subject has a serum Cryptomeria japonica pollen-specific IgE concentration of 0.73 UA / mL or less.

[0044]

[33] The composition according to any one of

[27] to

[32] , wherein the symptom is at least one selected from sneezing attacks, runny nose, nasal congestion, itchy nose, itchy eyes, and tearing.

[0045]

[34] The composition according to

[33] , wherein the symptom is at least one selected from sneezing attacks, runny nose, itchy eyes, and tearing.

[0046]

[35] The composition according to any one of

[27] to

[34] , wherein the composition is used in a manner of oral administration to the subject at 4 mg / kg body weight / day or more of DGLA.

[0047]

[36] The composition according to any one of

[27] to

[35] , wherein DGLA is in any form of glyceride, phospholipid, glycolipid, alkyl ester, salt, or free fatty acid.

[0048]

[37] The composition according to

[36] , wherein the glyceride is triglyceride, diglyceride, or monoglyceride.

[0049]

[38] The composition according to

[36] , wherein the alkyl ester is an ester with a lower alcohol having 1 to 4 carbon atoms.

[0050]

[39] The composition according to

[36] , wherein the phospholipid is diacylglycerol phospholipid or lysophosphatidylglycerol.

[0051]

[40] The composition according to

[27] to

[39] , wherein the composition is a pharmaceutical composition, a food composition, or a food additive.

[0052]

[41] The composition according to any one of

[27] to

[40] , wherein the composition is used in a manner of orally administering 4 mg / kg body weight / day to 500 mg / kg body weight / day of DGLA to a subject.

[0053]

[42] The composition according to any one of

[27] to

[41] , wherein the composition is orally administered for 1 week or more.

[0054]

[43] The composition according to

[28] , wherein the composition is taken before the start date of pollen scattering or at the initial stage of pollen scattering.

[0055]

[44] A composition containing dihomo- γ -γ-linolenic acid (DGLA) as an active ingredient for use in the manufacture of a composition for alleviating or preventing symptoms of allergic rhinitis or allergic conjunctivitis.

[0056]

[45] The use according to

[44] , wherein the allergic rhinitis or allergic conjunctivitis is pollinosis.

[0057]

[46] The use according to

[45] , wherein the composition is used in a manner of orally administering to a subject having symptoms of allergic rhinitis or allergic conjunctivitis at the initial stage of pollen scattering.

[0058]

[47] The use according to

[46] , wherein in the subject, the score of at least one selected from sneezing attacks, runny nose, nasal congestion, itchy eyes, and tearing in the severity classification of allergic rhinitis symptoms is 1 or more at the initial stage of pollen scattering.

[0059]

[48] The use according to

[46] , wherein in the subject, the score of at least one selected from runny nose, sneezing, nasal congestion, nasal itching, itchy eyes, and tearing in the Japanese Allergic Rhinitis QOL questionnaire is 1 or more at the initial stage of pollen scattering.

[0060]

[49] The use according to

[46] , wherein the subject has a serum Japanese cedar pollen-specific IgE concentration of 0.73 UA / mL or less.

[0061]

[50] The use according to any one of

[44] to

[49] , wherein the symptoms are at least one selected from sneezing attacks, runny nose, nasal congestion, nasal itching, itchy eyes, and tearing.

[0062]

[51] The use according to

[50] , wherein the symptoms are at least one selected from sneezing attacks, runny nose, itchy eyes, and tearing.

[0063]

[52] For the use according to any one of

[44] to

[51] , wherein the composition is used in a manner such that the amount of DGLA orally administered to the subject is 4 mg / kg body weight / day or more.

[0064]

[53] For the use according to any one of

[44] to

[52] , wherein DGLA is in any form of glyceride, phospholipid, glycolipid, alkyl ester, salt, or free fatty acid.

[0065]

[54] For the use according to

[53] , wherein the glyceride is triglyceride, diglyceride or monoglyceride.

[0066]

[55] For the use according to

[53] , wherein the alkyl ester is an ester with a lower alcohol having 1 to 4 carbon atoms.

[0067]

[56] For the use according to

[53] , wherein the phospholipid is diacylglycerol phospholipid or lysophospholipid.

[0068] Advantages of the Invention By ingesting the composition of the present invention, it is possible to alleviate or prevent the symptoms of allergic rhinitis or allergic conjunctivitis. Brief Description of the Drawings

[0069] Figure 1 Shows the increase and decrease in the score of sneezing attacks in the severity classification of allergic rhinitis symptoms from the start of the test (0 weeks). p < 0.01.

[0070] Figure 2 Shows the increase and decrease in the score of nasal congestion in the severity classification of allergic rhinitis symptoms from the start of the test (0 weeks). p < 0.05.

[0071] Figure 3 Shows the increase and decrease in the nasal and eye symptom score in JRQLQ from the start of the test (0 weeks). P < 0.1.

[0072] Figure 4 Shows the results of the stratified analysis of the score of sneezing attacks in the severity classification of allergic rhinitis symptoms for the DGLA group. H group: n = 15; L group: n = 3. P = 0.712.

[0073] Figure 5 Shows the results of the stratified analysis of the score of runny nose in the severity classification of allergic rhinitis symptoms for the DGLA group. H group: n = 15; L group: n = 3. P = 0.258.

[0074] Figure 6Indicates the score for nasal congestion in the severity classification of allergic rhinitis symptoms and the results of the stratified analysis of the DGLA group. Group H: n = 8; Group L: n = 10. P = 0.249.

[0075] Figure 7 Indicates the score for itchy eyes in the severity classification of allergic rhinitis symptoms and the results of the stratified analysis of the DGLA group. Group H: n = 14; Group L: n = 4. P = 0.303.

[0076] Figure 8 Indicates the score for tearing in the severity classification of allergic rhinitis symptoms and the results of the stratified analysis of the DGLA group. Group H: n = 7; Group L: n = 11. P = 0.284.

[0077] Figure 9 Indicates the score for runny nose in the JRQLQ and the results of the stratified analysis of the DGLA group. Group H: n = 15; Group L: n = 3. P = 0.582.

[0078] Figure 10 Indicates the score for sneezing in the JRQLQ and the results of the stratified analysis of the DGLA group. Group H: n = 16; Group L: n = 2. P = 0.345.

[0079] Figure 11 Indicates the score for nasal congestion in the JRQLQ and the results of the stratified analysis of the DGLA group. Group H: n = 13; Group L: n = 5. P = 0.126.

[0080] Figure 12 Indicates the score for itchy nose in the JRQLQ and the results of the stratified analysis of the DGLA group. Group H: n = 10; Group L: n = 8. P = 0.084.

[0081] Figure 13 Indicates the score for itchy eyes in the JRQLQ and the results of the stratified analysis of the DGLA group. Group H: n = 12; Group L: n = 6. P = 0.362.

[0082] Figure 14 Indicates the score for tearing in the JRQLQ and the results of the stratified analysis of the DGLA group. Group H: n = 12; Group L: n = 6. P = 0.59. Detailed implementation mode

[0083] The present invention provides a composition for alleviating or preventing the symptoms of allergic rhinitis or allergic conjunctivitis, which contains DGLA as an active ingredient (hereinafter, also referred to as the composition of the present invention).

[0084] In the present invention, dihomo- γDGLA (dihomo-gamma-linolenic acid) refers to an unsaturated fatty acid having 20 carbon atoms, 3 double bonds, and belonging to the n-6 series. The DGLA for the purpose of the present invention may be in any form such as free fatty acid, salts such as sodium and potassium salts, lower alkyl esters having 1 to 4 carbon atoms such as ethyl ester and methyl ester, glycerine esters such as triglyceride, diglyceride, and monoglyceride, phospholipids such as diacylglycerol phospholipid and lysophosphatidyl acylglycerol, and glycolipid, as long as it contains DGLA as a constituent fatty acid. DGLA is preferably in the form of an ester such as a glycerine ester or a lower alkyl ester, more preferably in the form of a glycerine ester, and even more preferably in the form of a triglyceride.

[0085] DGLA can be mass-produced by the method disclosed in Japanese Patent No. 3354581. Specifically, it is obtained by culturing a microorganism of the genus Mortierella, particularly Mortierella alpina, which produces an oil containing DGLA, and extracting the oil from the cells. By this method, an oil having a DGLA content (proportion) of 30 to 50% by weight in the fatty acid composition can be obtained. In the present invention, this oil can be used directly, or DGLA can be further concentrated and then used. Specifically, the oil containing DGLA can be concentrated by winterization treatment, enzymatic treatment with lipase, etc. Alternatively, the oil containing DGLA can be converted into free fatty acid, its salt, and an ester with a lower alcohol by hydrolysis or alcoholysis and then used. Furthermore, concentration can also be carried out by distillation treatment, urea addition treatment, column treatment, enzymatic treatment, supercritical carbon dioxide treatment, etc.

[0086] The concentration of DGLA in the composition of the present invention, that is, the proportion of DGLA in the fatty acid composition of the composition of the present invention relative to the total fatty acids can be about 0.01 to 50% by weight, for example, 0.05 to 50% by weight, 0.1 to 50% by weight, 0.5 to 50% by weight, 1.0 to 50% by weight, 5.0 to 50% by weight, 10 to 50% by weight, 20 to 50% by weight, 30 to 50% by weight, 30 to 45% by weight, 30 to 40% by weight, or 30 to 35% by weight, and is preferably 30 to 35% by weight.

[0087] In this specification, the proportion (% by weight) of a fatty acid in the fatty acid composition of a composition, unless otherwise specified, is calculated based on the value measured by gas chromatography after esterifying the components in the composition according to "AOCS official method Ce1b-89". The case where the concentration or content of a fatty acid is referred to also means the proportion (% by weight) of the fatty acid relative to the above total fatty acids. The analysis conditions for gas chromatography are as follows.

[0088] Apparatus: Agilent 6850 GC system (Agilent Corporation) Column: DB-WAX (Agilent Technologies, 30 m x 0.32 mm ID, 0.25 μm film thickness) Carrier gas: Helium (2.2 mL / min, constant flow) Injector temperature: 250 °C Injection volume: 1 μL Injection method: Split Split ratio: 50:1 Column oven: 170 °C - 1 °C / min - 225 °C Detector: FID Detector temperature: 300 °C In the present invention, "allergic rhinitis" refers to a disease in which allergens invade the body and cause an immune reaction, thereby causing nasal symptoms such as sneezing attacks, runny nose, and nasal congestion. In addition, in the present invention, "allergic conjunctivitis" refers to a disease in which allergens invade the body and cause an immune reaction, thereby causing eye symptoms such as itchy eyes and tearing. Allergic rhinitis or allergic conjunctivitis includes perennial and seasonal types. Perennial allergic rhinitis or allergic conjunctivitis can occur throughout the year due to indoor dust (e.g., fungal spores, fabric fibers, animal dander, mites, insect corpses), etc. Seasonal allergic rhinitis or allergic conjunctivitis can occur during specific periods of the year due to pollen, etc.

[0089] In a preferred embodiment of the present invention, allergic rhinitis or allergic conjunctivitis can be seasonal allergic rhinitis or allergic conjunctivitis, and more preferably can be hay fever. Examples of hay fever include: cedar pollinosis, cypress pollinosis, ragweed pollinosis, rice pollinosis, zelkova pollinosis, orchardgrass pollinosis, white birch pollinosis, Quercus serrata pollinosis, alder pollinosis, Pinus pollinosis, etc. In a preferred embodiment of the present invention, allergic rhinitis or allergic conjunctivitis can be cedar or cypress pollinosis.

[0090] In the present invention, "having symptoms of allergic rhinitis or allergic conjunctivitis" means satisfying at least one of the following (i) and (ii).

[0091] (i) The score of at least one selected from sneezing attacks, runny nose, nasal congestion, itchy eyes, and tearing in the severity classification of allergic rhinitis symptoms is 1 or more.

[0092] (ii) In the subject, the score of at least one selected from runny nose, sneezing, nasal congestion, itchy nose, itchy eyes, and tearing in the Japanese Allergic Rhinitis QOL Questionnaire (JRQLQ) is 1 or more.

[0093] Therefore, the subject in the present invention only needs to have the subjective symptoms shown by satisfying at least one of the above (i) and (ii), and does not necessarily receive a doctor's diagnosis of having "allergic rhinitis or allergic conjunctivitis". In one embodiment, the subject of the present invention can be a person who has discomfort in the nose or eyes caused by allergens such as pollen but does not have "allergic rhinitis or allergic conjunctivitis" (or at least a person who has not received a doctor's diagnosis of having "allergic rhinitis or allergic conjunctivitis").

[0094] The severity classification of allergic rhinitis symptoms is a classification method based on the severity of the 2020 version of the Nasal Allergy Treatment Guidelines (Nasal Allergy Treatment Guidelines Making Committee). Specifically, the subject himself selects the item that conforms to the degree of the day for the subjective symptoms related to each item described in the following table every night.

[0095] [Table 1] JRQLQ is a questionnaire (Minoru Okuda et al.: Japanese Allergic Rhinitis QOL Standard Questionnaire (2002 Edition), Japanese Allergic Rhinitis QOL Standard Questionnaire Making Committee, Allergy 2003; 52: 21-56) made by Okuda et al. on the impact of allergic rhinitis on quality of life (QOL). It is reported that there is a significant correlation between JRQLQ and the Japanese version of the Rhino-conjunctivitis Quality of Life Questionnaire (RQLQ) used worldwide, that is, the Japanese version of the Allergic Rhinoconjunctivitis QOL Questionnaire (the Japanese version of the Rhino-conjunctivitis Quality of Life Questionnaire; RQLQJ) (Journal of the Japanese Rhinological Society, 52(4): 499-505, 2013). In JRQLQ, the subject himself selects the item that conforms to the degree of the most severe nasal and eye symptoms in the most recent 1-2 weeks for the items described in the following table.

[0096] [Table 2] In the present invention, the symptoms of allergic rhinitis or allergic conjunctivitis are not particularly limited and may be at least one selected from the group consisting of sneezing attacks, runny nose, nasal congestion, nasal itching, eye itching, and tearing.

[0097] As shown in the examples described hereinafter, the composition of the present invention can, in particular, significantly reduce the score of sneezing attacks or nasal congestion in the severity classification of allergic rhinitis symptoms or suppress the increase in the score, as compared with the placebo group. Therefore, in a preferred embodiment of the present invention, the symptoms of allergic rhinitis or allergic conjunctivitis may be at least one selected from sneezing and nasal congestion. In addition, the composition of the present invention can be used to reduce the score of sneezing attacks or nasal congestion in the severity classification of allergic rhinitis symptoms or suppress the increase in the score, as compared with the placebo group.

[0098] In addition, as shown in the examples described hereinafter, the composition of the present invention can reduce the nasal and eye symptom score in JRQLQ or suppress the increase in the score, as compared with the placebo group. In the present invention, the "nasal and eye symptom score in JRQLQ" refers to the sum of the scores of runny nose, sneezing, nasal congestion, nasal itching, eye itching, and tearing in JRQLQ. In a preferred embodiment of the present invention, the composition of the present invention can be used to reduce the nasal and eye symptom score in JRQLQ or suppress the increase in the score, as compared with the placebo group.

[0099] Among the symptoms of allergic rhinitis or allergic conjunctivitis, it is known that sneezing attacks, runny nose, eye itching, and tearing are caused by the action of histamine. So far, no effect of DGLA uptake on the action of histamine in allergic rhinitis or allergic conjunctivitis has been reported. In a preferred embodiment of the present invention, the symptoms of allergic rhinitis or allergic conjunctivitis can be symptoms caused by histamine, specifically at least one selected from sneezing attacks, nasal discharge, eye itching, and tearing.

[0100] The administration subject of the composition of the present invention is a mammal, preferably a human. In one embodiment, the composition of the present invention can be administered to a subject in need of alleviating or preventing the symptoms of allergic rhinitis or allergic conjunctivitis. The composition of the present invention can also be used for non-therapeutic purposes.

[0101] In the case where allergic rhinitis or allergic conjunctivitis is pollinosis, in one embodiment, the composition of the present invention can be administered to an object having symptoms of allergic rhinitis or allergic conjunctivitis at the initial stage of the scattering of pollen (e.g., cedar or cypress pollen) as an allergen. In the present invention, the "initial stage of pollen scattering" refers to the period when a small amount of pollen scattering is detected before the start date of pollen scattering in the region where the object resides (e.g., prefecture or municipality in Japan if it is Japan). In one embodiment, the "initial stage of pollen scattering" can be the period from 6 weeks before the start date of pollen scattering in the region where the object resides (e.g., prefecture or municipality in Japan if it is Japan) to the start date of pollen scattering. Here, the "start date of pollen scattering" refers to the day before the period when the amount of pollen scattering as an allergen starts to increase in the region where the object resides (e.g., Japan, prefecture or municipality), (e.g., 1 day to 2 weeks before), and the first day when 1 or more pollen grains are detected per 1 cm 2 by the Durham method for 2 consecutive days. In particular, regarding the start date of cedar pollen scattering in Japan, it is defined by the Pollen Information Standardization Committee of the Japan Allergy Association, a public interest incorporated foundation.

[0102] The "initial stage of pollen scattering", for example, can be the period from 6 weeks before to 1 week before the start date of pollen scattering, the period from 6 weeks before to 2 weeks before the start date of pollen scattering, the period from 6 weeks before to 3 weeks before the start date of pollen scattering, the period from 6 weeks before to 4 weeks before the start date of pollen scattering, or the period from 6 weeks before to 5 weeks before the start date of pollen scattering, and preferably can be the period from 6 weeks before to 5 weeks before the start date of pollen scattering. At the initial stage of pollen scattering, pollen scatters slightly, and an object having symptoms of allergic rhinitis or allergic conjunctivitis at the initial stage of pollen scattering can be said to be more sensitive to pollen as the allergen of such symptoms. The composition of the present invention can show a higher effect on such an object.

[0103] In one embodiment, an object having symptoms of allergic rhinitis or allergic conjunctivitis at the initial stage of pollen scattering can be, for example: an object with a score of 1 or more for at least one selected from sneezing attacks, runny nose, nasal congestion, itchy eyes, and tearing in the severity classification of allergic rhinitis symptoms at the initial stage of pollen scattering; or an object with a score of 1 or more for at least one selected from runny nose, sneezing, nasal congestion, itchy nose, itchy eyes, and tearing in the Japan Allergic Rhinitis QOL questionnaire at the initial stage of pollen scattering.

[0104] In one embodiment, preferably, a subject having symptoms of allergic rhinitis or allergic conjunctivitis at the initial stage of pollen dispersal and having a score of nasal itching of 1 or more in the Japanese Allergic Rhinitis QOL questionnaire at the initial stage of pollen dispersal can have a Japanese cedar pollen-specific IgE concentration in the serum of 0.73 UA / mL or less.

[0105] The composition of the present invention can be prepared in forms suitable for pharmaceutical compositions, food compositions (such as functional foods, health foods, dietary supplements, etc.), food additives, etc., such as various solid preparations such as granules (including dry syrups), capsules (soft capsules, hard capsules), tablets (including chewable tablets, etc.), powders (powders), pills, etc., or liquid preparations for oral administration (including liquids, suspensions, syrups), etc. For example, the composition of the present invention can be formulated by filling the active ingredient into a soft capsule coated with gelatin.

[0106] Examples of additives for formulation include excipients, lubricants, binders, disintegrants, fluidizing agents, dispersants, wetting agents, preservatives, thickeners, pH regulators, colorants, flavoring agents, surfactants, solubilizing aids. In addition, in the case of preparing a liquid form, thickeners such as pectin, xanthan gum, and guar gum can be added. In addition, coated tablets can be prepared using a coating agent, or a paste-like gum agent can be prepared. Furthermore, in the case of preparing other forms, the conventional methods can be followed.

[0107] The composition of the present invention can be in the form of a food composition or a food additive. In the present invention, the food composition refers to all foods including beverages, and in addition to general foods including health foods such as dietary supplements, it also includes foods for specified health uses and foods with nutritional functions defined in the health functional food system of the Consumer Affairs Agency. For example, a functional food with a label indicating the main purpose of reducing nasal and eye discomfort caused by allergens such as pollen is provided. For example, oils containing DGLA can be directly provided. In addition, the food composition or food additive of the present invention also includes food raw materials, which are used to impart the effect of reducing or preventing the symptoms of allergic rhinitis or allergic conjunctivitis by adding, mixing, or coating other foods. In addition to foods, it can also be provided as animal feed, etc.

[0108] The food composition or food additive of the present invention can be prepared by incorporating the composition of the present invention into the food composition or food additive, thereby imparting the function of reducing or preventing the symptoms of allergic rhinitis or allergic conjunctivitis.

[0109] The food compositions of the present invention can be beverages, snacks, breads, soups, etc. For example, they include general sterilized bagged foods, frozen foods, convenience foods (such as noodles), canned foods, sausages, cookies, crackers, cereal bars, crackers, snacks (such as potato chips), pastries, cakes, pies, candies, chewing gums (including spherical and rod-shaped), jellies, soups, ice creams, dressings, yogurts, etc., dietary supplements in the form of tablets, capsules, emulsions, soft drinks, etc. The manufacturing methods of these foods are not particularly limited as long as the effects of the present invention are not impaired, and for each food, the methods used by those skilled in the art can be followed.

[0110] The scope of the present invention includes the case of selling the products related to the present invention by showing the effects exerted by the compositions of the present invention on the packaging containers, product manuals, and brochures. In addition, the scope of the present invention also includes the case of promoting and selling the products related to the present invention by showing the effects of the present invention on televisions, Internet websites, brochures, newspapers, magazines, etc. In the case of making the compositions of the present invention into pharmaceuticals or quasi-pharmaceuticals, the functions and effects of alleviating or preventing the symptoms of allergic rhinitis or allergic conjunctivitis can be shown on the packaging containers, etc.

[0111] In the present invention, the amount of the active ingredient ingested by the subject is not particularly limited, and for example, it is ingested in an amount exceeding the effective amount for obtaining the desired effect. Here, the effective amount for obtaining the desired effect refers to the amount required to alleviate or prevent the symptoms of allergic rhinitis or allergic conjunctivitis. For example, in the case of an adult, depending on conditions such as the age, weight, and health status of the subject, it is possible to ingest DGLA (converted to free fatty acid) as the active ingredient at 4 mg / kg body weight / day or more, for example, 5 mg / kg body weight / day or more, 6 mg / kg body weight / day or more, 7 mg / kg body weight / day or more, 8 mg / kg body weight / day or more, 9 mg / kg body weight / day or more, 10 mg / kg body weight / day or more, 50 mg / kg body weight / day or more, or 100 mg / kg body weight / day or more. In addition, since the active ingredient of the composition of the present invention does not have strong side effects, there is no upper limit to the daily intake amount, and for example, it can be 500 mg / kg body weight / day or less, 400 mg / kg body weight / day or less, 200 mg / kg body weight / day or less, or 150 mg / kg body weight / day or less. In one embodiment, the composition of the present invention can be used in such a way that DGLA of 4 mg / kg body weight / day to 500 mg / kg body weight / day, for example, 4 mg / kg body weight / day to 400 mg / kg body weight / day, 4 mg / kg body weight / day to 200 mg / kg body weight / day, 4 mg / kg body weight / day to 150 mg / kg body weight / day, 4 mg / kg body weight / day to 50 mg / kg body weight / day, 4 mg / kg body weight / day to 10 mg / kg body weight / day, 4 mg / kg body weight / day to 9 mg / kg body weight / day, 4 mg / kg body weight / day to 8 mg / kg body weight / day, or 4 mg / kg body weight / day to 7 mg / kg body weight / day is orally administered to the subject.

[0112] In one embodiment, the composition of the present invention can be used in such a way that DGLA (converted to free fatty acid) as the active ingredient of 314 mg / day or more, for example, 400 mg / day or more, 500 mg / day or more, 600 mg / day or more, 700 mg / day or more, 800 mg / day or more, 900 mg / day or more, or 1000 mg / day or more is orally administered to the subject.

[0113] There is no particular limitation on the ingestion time of the composition of the present invention, and it can be 1 week or more, for example, 2 weeks or more, 3 weeks or more, 4 weeks or more, 5 weeks or more, 6 weeks or more, 7 weeks or more, 8 weeks or more, 9 weeks or more, 10 weeks or more, 11 weeks or more, 12 weeks or more, 13 weeks or more, 14 weeks or more, or 15 weeks or more.

[0114] In the case where allergic rhinitis or allergic conjunctivitis is pollinosis, in one embodiment, the composition of the present invention can be used in such a manner that ingestion is started before the start date of pollen scattering, for example, more than 1 week before, more than 2 weeks before, more than 3 weeks before, more than 4 weeks before, more than 5 weeks before, or more than 6 weeks before the start date of pollen scattering. In another embodiment, the composition of the present invention can be used in such a manner that ingestion is started during the initial stage of pollen scattering, for example, from 6 weeks before to 1 week before the start date of pollen scattering, from 6 weeks before to 2 weeks before the start date of pollen scattering, from 6 weeks before to 3 weeks before the start date of pollen scattering, from 6 weeks before to 4 weeks before the start date of pollen scattering, or from 6 weeks before to 5 weeks before the start date of pollen scattering. Additionally, the composition of the present invention can be ingested until the end date of pollen scattering, or ingestion can be continued after the end date of pollen scattering. In the present invention, the "end date of pollen scattering" means that in the region where the subject resides (for example, in Japan, it is a prefecture or a municipality), after the scattering amount exceeds the peak, by the Durham method, for 3 consecutive days, every 1 cm 2 has 0 on the day before the first day.

[0115] In a preferred embodiment, the composition of the present invention can be a composition for alleviating or preventing the symptoms of allergic rhinitis or allergic conjunctivitis, which contains DGLA as an active ingredient, Allergic rhinitis or allergic conjunctivitis is pollinosis, preferably cedar or cypress pollinosis, The symptom of allergic rhinitis or allergic conjunctivitis is sneezing attack, DGLA is a triglyceride, preferably a triglyceride, It can be used in such a manner that 4 mg / kg body weight / day or more, 5 mg / kg body weight / day or more, 6 mg / kg body weight / day or more, 7 mg / kg body weight / day or more, 8 mg / kg body weight / day or more, 9 mg / kg body weight / day or more, 10 mg / kg body weight / day or more, 50 mg / kg body weight / day or more, or 100 mg / kg body weight / day or more of DGLA is orally administered to the subject.

[0116] In a preferred embodiment, the composition of the present invention can be a composition for alleviating or preventing the symptoms of allergic rhinitis or allergic conjunctivitis, which contains DGLA as an active ingredient, Allergic rhinitis or allergic conjunctivitis is pollinosis, preferably cedar or cypress pollinosis, The symptom of allergic rhinitis or allergic conjunctivitis is nasal congestion, DGLA is a triglyceride, preferably a triglyceride, It can be used in a manner such that DGLA is orally administered to a subject at 4 mg / kg body weight / day or more, 5 mg / kg body weight / day or more, 6 mg / kg body weight / day or more, 7 mg / kg body weight / day or more, 8 mg / kg body weight / day or more, 9 mg / kg body weight / day or more, 10 mg / kg body weight / day or more, 50 mg / kg body weight / day or more, or 100 mg / kg body weight / day or more.

[0117] In a preferred embodiment, the composition of the present invention can be a composition for alleviating or preventing symptoms of allergic rhinitis or allergic conjunctivitis, which contains DGLA as an active ingredient. Allergic rhinitis or allergic conjunctivitis is pollinosis, preferably cedar or cypress pollinosis. The symptoms of allergic rhinitis or allergic conjunctivitis are sneezing attacks. It can be used in a manner of oral administration for a subject with a sneezing attack score of 1 or more in the severity classification of allergic rhinitis symptoms during the early stage of pollen dispersal, such as from 6 weeks before to 1 week before the start date of pollen dispersal, from 6 weeks before to 2 weeks before the start date of pollen dispersal, from 6 weeks before to 3 weeks before the start date of pollen dispersal, from 6 weeks before to 4 weeks before the start date of pollen dispersal, or from 6 weeks before to 5 weeks before the start date of pollen dispersal, preferably from 6 weeks before to 5 weeks before the start date of pollen dispersal. DGLA is a triglyceride, preferably a triglyceride. It can be used in a manner such that DGLA is orally administered to a subject at 4 mg / kg body weight / day or more, 5 mg / kg body weight / day or more, 6 mg / kg body weight / day or more, 7 mg / kg body weight / day or more, 8 mg / kg body weight / day or more, 9 mg / kg body weight / day or more, 10 mg / kg body weight / day or more, 50 mg / kg body weight / day or more, or 100 mg / kg body weight / day or more.

[0118] In a preferred embodiment, the composition of the present invention can be a composition for alleviating or preventing symptoms of allergic rhinitis or allergic conjunctivitis, which contains DGLA as an active ingredient. Allergic rhinitis or allergic conjunctivitis is pollinosis, preferably cedar or cypress pollinosis. The symptoms of allergic rhinitis or allergic conjunctivitis are sneezing attacks. Subjects for whom the score of sneezing attacks in the severity classification of allergic rhinitis symptoms can be used for oral administration is 1 or more during the early stage of pollen dispersal, such as from 6 weeks before to 1 week before the pollen dispersal start date, from 6 weeks before to 2 weeks before the pollen dispersal start date, from 6 weeks before to 3 weeks before the pollen dispersal start date, from 6 weeks before to 4 weeks before the pollen dispersal start date, or from 6 weeks before to 5 weeks before the pollen dispersal start date, preferably from 6 weeks before to 5 weeks before the pollen dispersal start date. DGLA is a triglyceride, preferably a triglyceride. It can be used in a manner such that the subject is orally administered 4 mg / kg body weight / day or more, 5 mg / kg body weight / day or more, 6 mg / kg body weight / day or more, 7 mg / kg body weight / day or more, 8 mg / kg body weight / day or more, 9 mg / kg body weight / day or more, 10 mg / kg body weight / day or more, 50 mg / kg body weight / day or more, or 100 mg / kg body weight / day or more of DGLA.

[0119] In a preferred embodiment, the composition of the present invention can be a composition for alleviating or preventing the symptoms of allergic rhinitis or allergic conjunctivitis, which contains DGLA as an active ingredient. Allergic rhinitis or allergic conjunctivitis is pollinosis, preferably cedar or cypress pollinosis. The symptoms of allergic rhinitis or allergic conjunctivitis are runny nose. Subjects for whom the score of runny nose in the severity classification of allergic rhinitis symptoms can be used for oral administration is 1 or more during the early stage of pollen dispersal, such as from 6 weeks before to 1 week before the pollen dispersal start date, from 6 weeks before to 2 weeks before the pollen dispersal start date, from 6 weeks before to 3 weeks before the pollen dispersal start date, from 6 weeks before to 4 weeks before the pollen dispersal start date, or from 6 weeks before to 5 weeks before the pollen dispersal start date, preferably from 6 weeks before to 5 weeks before the pollen dispersal start date. DGLA is a triglyceride, preferably a triglyceride. It can be used in a manner such that the subject is orally administered 4 mg / kg body weight / day or more, 5 mg / kg body weight / day or more, 6 mg / kg body weight / day or more, 7 mg / kg body weight / day or more, 8 mg / kg body weight / day or more, 9 mg / kg body weight / day or more, 10 mg / kg body weight / day or more, 50 mg / kg body weight / day or more, or 100 mg / kg body weight / day or more of DGLA.

[0120] In a preferred embodiment, the composition of the present invention can be a composition for alleviating or preventing the symptoms of allergic rhinitis or allergic conjunctivitis, which contains DGLA as an active ingredient. Allergic rhinitis or allergic conjunctivitis is pollinosis, preferably cedar or cypress pollinosis. The symptoms of allergic rhinitis or allergic conjunctivitis are nasal congestion, For the scoring of nasal congestion in the severity classification of allergic rhinitis symptoms that can be used in the form of oral administration, in the early stage of pollen dispersal, such as 6 weeks before to 1 week before the start date of pollen dispersal, 6 weeks before to 2 weeks before the start date of pollen dispersal, 6 weeks before to 3 weeks before the start date of pollen dispersal, 6 weeks before to 4 weeks before the start date of pollen dispersal, or 6 weeks before to 5 weeks before the start date of pollen dispersal, preferably in the period of 6 weeks before to 5 weeks before the start date of pollen dispersal, for subjects with a score of 1 or more. DGLA is a triglyceride, preferably a triglyceride. It can be used in such a way that 4 mg / kg body weight / day or more, 5 mg / kg body weight / day or more, 6 mg / kg body weight / day or more, 7 mg / kg body weight / day or more, 8 mg / kg body weight / day or more, 9 mg / kg body weight / day or more, 10 mg / kg body weight / day or more, 50 mg / kg body weight / day or more, or 100 mg / kg body weight / day or more of DGLA is orally administered to the subject.

[0121] In a preferred embodiment, the composition of the present invention can be a composition for alleviating or preventing the symptoms of allergic rhinitis or allergic conjunctivitis, which contains DGLA as an active ingredient. Allergic rhinitis or allergic conjunctivitis is pollinosis, preferably cedar or cypress pollinosis. The symptoms of allergic rhinitis or allergic conjunctivitis are itchy eyes. For the scoring of itchy eyes in the severity classification of allergic rhinitis symptoms that can be used in the form of oral administration, in the early stage of pollen dispersal, such as 6 weeks before to 1 week before the start date of pollen dispersal, 6 weeks before to 2 weeks before the start date of pollen dispersal, 6 weeks before to 3 weeks before the start date of pollen dispersal, 6 weeks before to 4 weeks before the start date of pollen dispersal, or 6 weeks before to 5 weeks before the start date of pollen dispersal, preferably in the period of 6 weeks before to 5 weeks before the start date of pollen dispersal, for subjects with a score of 1 or more. DGLA is a triglyceride, preferably a triglyceride. It can be used in such a way that 4 mg / kg body weight / day or more, 5 mg / kg body weight / day or more, 6 mg / kg body weight / day or more, 7 mg / kg body weight / day or more, 8 mg / kg body weight / day or more, 9 mg / kg body weight / day or more, 10 mg / kg body weight / day or more, 50 mg / kg body weight / day or more, or 100 mg / kg body weight / day or more of DGLA is orally administered to the subject.

[0122] In a preferred embodiment, the composition of the present invention can be a composition for alleviating or preventing the symptoms of allergic rhinitis or allergic conjunctivitis, which contains DGLA as an active ingredient. Allergic rhinitis or allergic conjunctivitis is pollinosis, preferably cedar or cypress pollinosis, The symptoms of allergic rhinitis or allergic conjunctivitis are tearing, For the severity classification of the symptoms of allergic rhinitis by oral administration, the score for tearing is 1 or more in the early stage of pollen dispersal, such as from 6 weeks before to 1 week before the start date of pollen dispersal, from 6 weeks before to 2 weeks before the start date of pollen dispersal, from 6 weeks before to 3 weeks before the start date of pollen dispersal, from 6 weeks before to 4 weeks before the start date of pollen dispersal, or from 6 weeks before to 5 weeks before the start date of pollen dispersal, preferably from 6 weeks before to 5 weeks before the start date of pollen dispersal. The object is such that the score is 1 or more. DGLA is a triglyceride, preferably a triglyceride, It can be used by orally administering 4 mg / kg body weight / day or more, 5 mg / kg body weight / day or more, 6 mg / kg body weight / day or more, 7 mg / kg body weight / day or more, 8 mg / kg body weight / day or more, 9 mg / kg body weight / day or more, 10 mg / kg body weight / day or more, 50 mg / kg body weight / day or more, or 100 mg / kg body weight / day or more of DGLA to the object.

[0123] In a preferred embodiment, the composition of the present invention can be a composition for alleviating or preventing the symptoms of allergic rhinitis or allergic conjunctivitis, which contains DGLA as an active ingredient, Allergic rhinitis or allergic conjunctivitis is pollinosis, preferably cedar or cypress pollinosis, The symptoms of allergic rhinitis or allergic conjunctivitis are runny nose, For the score of runny nose in JRQLQ by oral administration, it can be used for objects with a score of 1 or more in the early stage of pollen dispersal, such as from 6 weeks before to 1 week before the start date of pollen dispersal, from 6 weeks before to 2 weeks before the start date of pollen dispersal, from 6 weeks before to 3 weeks before the start date of pollen dispersal, from 6 weeks before to 4 weeks before the start date of pollen dispersal, or from 6 weeks before to 5 weeks before the start date of pollen dispersal, preferably from 6 weeks before to 5 weeks before the start date of pollen dispersal. DGLA is a triglyceride, preferably a triglyceride, It can be used by orally administering 4 mg / kg body weight / day or more, 5 mg / kg body weight / day or more, 6 mg / kg body weight / day or more, 7 mg / kg body weight / day or more, 8 mg / kg body weight / day or more, 9 mg / kg body weight / day or more, 10 mg / kg body weight / day or more, 50 mg / kg body weight / day or more, or 100 mg / kg body weight / day or more of DGLA to the object.

[0124] In a preferred embodiment, the composition of the present invention can be a composition for alleviating or preventing the symptoms of allergic rhinitis or allergic conjunctivitis, which contains DGLA as an active ingredient. Allergic rhinitis or allergic conjunctivitis is pollinosis, preferably cedar or cypress pollinosis. The symptoms of allergic rhinitis or allergic conjunctivitis are sneezing attacks. It can be used in the form of oral administration for subjects with a JRQLQ score for sneezing of 1 or more during the early stage of pollen dispersal, such as from 6 weeks before to 1 week before the start date of pollen dispersal, from 6 weeks before to 2 weeks before the start date of pollen dispersal, from 6 weeks before to 3 weeks before the start date of pollen dispersal, from 6 weeks before to 4 weeks before the start date of pollen dispersal, or from 6 weeks before to 5 weeks before the start date of pollen dispersal, preferably from 6 weeks before to 5 weeks before the start date of pollen dispersal. DGLA is a triglyceride, preferably a triglyceride. It can be used in the form of orally administering 4 mg / kg body weight / day or more, 5 mg / kg body weight / day or more, 6 mg / kg body weight / day or more, 7 mg / kg body weight / day or more, 8 mg / kg body weight / day or more, 9 mg / kg body weight / day or more, 10 mg / kg body weight / day or more, 50 mg / kg body weight / day or more, or 100 mg / kg body weight / day or more of DGLA to the subject.

[0125] In a preferred embodiment, the composition of the present invention can be a composition for alleviating or preventing the symptoms of allergic rhinitis or allergic conjunctivitis, which contains DGLA as an active ingredient. Allergic rhinitis or allergic conjunctivitis is pollinosis, preferably cedar or cypress pollinosis. The symptoms of allergic rhinitis or allergic conjunctivitis are nasal congestion. It can be used in the form of oral administration for subjects with a JRQLQ score for nasal congestion of 1 or more during the early stage of pollen dispersal, such as from 6 weeks before to 1 week before the start date of pollen dispersal, from 6 weeks before to 2 weeks before the start date of pollen dispersal, from 6 weeks before to 3 weeks before the start date of pollen dispersal, from 6 weeks before to 4 weeks before the start date of pollen dispersal, or from 6 weeks before to 5 weeks before the start date of pollen dispersal, preferably from 6 weeks before to 5 weeks before the start date of pollen dispersal. DGLA is a triglyceride, preferably a triglyceride. It can be used in a manner of orally administering DGLA to an object at 4 mg / kg body weight / day or more, 5 mg / kg body weight / day or more, 6 mg / kg body weight / day or more, 7 mg / kg body weight / day or more, 8 mg / kg body weight / day or more, 9 mg / kg body weight / day or more, 10 mg / kg body weight / day or more, 50 mg / kg body weight / day or more, or 100 mg / kg body weight / day or more.

[0126] In a preferred embodiment, the composition of the present invention can be a composition for alleviating or preventing symptoms of allergic rhinitis or allergic conjunctivitis, which contains DGLA as an active ingredient. Allergic rhinitis or allergic conjunctivitis is hay fever, preferably cedar or cypress hay fever. The symptoms of allergic rhinitis or allergic conjunctivitis are nasal itching. It can be used in a manner of oral administration for an object with a score of nasal itching in JRQLQ being 1 or more during the early stage of pollen scattering, such as from 6 weeks before to 1 week before the pollen scattering start date, from 6 weeks before to 2 weeks before the pollen scattering start date, from 6 weeks before to 3 weeks before the pollen scattering start date, from 6 weeks before to 4 weeks before the pollen scattering start date, or from 6 weeks before to 5 weeks before the pollen scattering start date, preferably from 6 weeks before to 5 weeks before the pollen scattering start date. DGLA is a triglyceride, preferably a triglyceride. It can be used in a manner of orally administering DGLA to an object at 4 mg / kg body weight / day or more, 5 mg / kg body weight / day or more, 6 mg / kg body weight / day or more, 7 mg / kg body weight / day or more, 8 mg / kg body weight / day or more, 9 mg / kg body weight / day or more, 10 mg / kg body weight / day or more, 50 mg / kg body weight / day or more, or 100 mg / kg body weight / day or more.

[0127] In a preferred embodiment, the composition of the present invention can be a composition for alleviating or preventing symptoms of allergic rhinitis or allergic conjunctivitis, which contains DGLA as an active ingredient. Allergic rhinitis or allergic conjunctivitis is hay fever, preferably cedar or cypress hay fever. The symptoms of allergic rhinitis or allergic conjunctivitis are eye itching. It can be used in a manner of oral administration for an object with a score of eye itching in JRQLQ being 1 or more during the early stage of pollen scattering, such as from 6 weeks before to 1 week before the pollen scattering start date, from 6 weeks before to 2 weeks before the pollen scattering start date, from 6 weeks before to 3 weeks before the pollen scattering start date, from 6 weeks before to 4 weeks before the pollen scattering start date, or from 6 weeks before to 5 weeks before the pollen scattering start date, preferably from 6 weeks before to 5 weeks before the pollen scattering start date. DGLA is a triglyceride, preferably a triglyceride, and can be used in a manner such that the DGLA is orally administered to a subject at 4 mg / kg body weight / day or more, 5 mg / kg body weight / day or more, 6 mg / kg body weight / day or more, 7 mg / kg body weight / day or more, 8 mg / kg body weight / day or more, 9 mg / kg body weight / day or more, 10 mg / kg body weight / day or more, 50 mg / kg body weight / day or more, or 100 mg / kg body weight / day or more.

[0128] In a preferred embodiment, the composition of the present invention can be a composition for alleviating or preventing symptoms of allergic rhinitis or allergic conjunctivitis, which contains DGLA as an active ingredient, and the allergic rhinitis or allergic conjunctivitis is pollinosis, preferably cedar or cypress pollinosis, and the symptoms of allergic rhinitis or allergic conjunctivitis are tearing, and can be used in a manner of oral administration for a subject whose score of tearing in JRQLQ is 1 or more in the early stage of pollen scattering, for example, from 6 weeks before to 1 week before the start date of pollen scattering, from 6 weeks before to 2 weeks before the start date of pollen scattering, from 6 weeks before to 3 weeks before the start date of pollen scattering, from 6 weeks before to 4 weeks before the start date of pollen scattering, or from 6 weeks before to 5 weeks before the start date of pollen scattering, preferably from 6 weeks before to 5 weeks before the start date of pollen scattering. DGLA is a triglyceride, preferably a triglyceride, and can be used in a manner such that the DGLA is orally administered to a subject at 4 mg / kg body weight / day or more, 5 mg / kg body weight / day or more, 6 mg / kg body weight / day or more, 7 mg / kg body weight / day or more, 8 mg / kg body weight / day or more, 9 mg / kg body weight / day or more, 10 mg / kg body weight / day or more, 50 mg / kg body weight / day or more, or 100 mg / kg body weight / day or more.

[0129] In one aspect, the present invention can provide a method for alleviating or preventing symptoms of allergic rhinitis or allergic conjunctivitis, the method comprising administering to a subject an effective amount of the composition of the present invention. This method can be implemented according to the description in this specification regarding the ingestion or administration of the composition of the present invention.

[0130] Examples Next, examples are listed to further illustrate the present invention, but the present invention is not limited to these examples.

[0131] Example 1 1. Materials and methods (1) Subjects Adult men and women with nasal and eye discomfort caused by pollen in the past two years were recruited. Eligibility was evaluated for 49 subjects, and 13 who did not meet the following criteria were excluded.

[0132] · Healthy Japanese men and women aged 20 or older · Those with nasal and eye discomfort caused by pollen in the past two years · Those who do not use allergy medications (excluding those who occasionally use allergy medications for nasal and eye discomfort caused by pollen) The remaining 36 subjects were randomly divided into an 18 - subject DGLA administration group (intervention group; hereinafter referred to as the DGLA group) and an 18 - subject placebo administration group (control group; hereinafter referred to as the placebo group). During the trial, 3 subjects in the placebo group could not be traced. Therefore, 18 subjects in the DGLA group and 15 subjects in the placebo group were analyzed.

[0133] The data related to the analyzed subjects are shown below.

[0134] [Table 3] (2)Test foods DGLA group: Consumed oil containing DGLA (31.4 wt% DGLA) at 1000 mg / day for 15 weeks. Converted to free fatty acids, it is equivalent to consuming 314 mg / day of DGLA. The oil containing DGLA was obtained by the method described in Japanese Patent No. 3354581. Specifically, 500 mL of hexane was added to 200 g of dried cells of the filamentous fungus (Mortierella alpina), and the stirring and filtration operations were repeated 3 times to extract the oil fraction. The hexane layer was evaporated to obtain the oil containing DGLA. The subjects consumed soft capsules filled with the oil containing DGLA at 4 capsules / day.

[0135] Placebo group: Consumed olive oil (without DGLA; refined olive oil, manufactured by DSP Gohsei Food & Chemical Co., Ltd. (currently Sumitomo Pharma Food & Chemical Co., Ltd.)) at 1000 mg / day for 15 weeks.

[0136] (3)Test food intake time The 15 - week period from January 8 to April 23, 2022 was set as the test food intake time. It should be noted that in Tokyo, where the trial was conducted, February 15, 38 days after the start date of test food intake (January 8), was the start date of cedar pollen scattering, and pollen scattering continued until the end of the trial.

[0137] (4)Measurement items Main evaluation items: Severity classification of allergic rhinitis symptoms, Japanese Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ) Secondary evaluation items: Serum allergen-specific IgE concentrations (house dust, mites, cedar, cypress), serum histamine levels, serum IL-6 levels, and the number of eosinophils in nasal discharge Serum allergen-specific IgE concentrations were measured by fluorescence enzyme immunoassay (FEIA). Serum histamine levels were measured by enzyme immunoassay (EIA). Serum IL-6 levels were measured by electrochemiluminescence immunoassay (ECLIA). The number of eosinophils in nasal discharge was measured by Wright's stain.

[0138] (5) Statistical analysis For the changes in scores from the start of the trial, the mean ± SD of each group at each time point was calculated and statistical analysis was performed. The analysis used a mixed-effect model for repeated measures.

[0139] 2. Results Regarding the severity classification of allergic rhinitis symptoms, in the DGLA group, sneezing attacks and nasal congestion were significantly reduced ( Figure 1 and 2 ; p < 0.01 for sneezing attacks and p < 0.05 for nasal congestion). Additionally, regarding JRQLQ, in the DGLA group, a trend of reduction in the nasal and ocular symptom score (i.e., the sum of scores for runny nose, sneezing, nasal congestion, nasal itching, ocular itching, and tearing) was observed ( Figure 3 ; P < 0.1).

[0140] Furthermore, a stratified analysis was performed on the DGLA group.

[0141] First, in the DGLA group, for each item related to the nose and eyes in the severity classification at week 0 (start of the trial) (sneezing attacks, runny nose, nasal congestion, ocular itching, and tearing), those with a score of 1 or more (group H: with mild or more severe symptoms) and those with a score of 0 (group L: without any symptoms) were compared for the trial results.

[0142] As a result, no significant inter-group differences were found, but in all items, the mean value of group H was lower than that of group L ( Figures 4 to 8: The attack rates were as follows: sneezing, P = 0.712; runny nose, P = 0.258; nasal congestion, P = 0.249; and tearing, P = 0.284). Therefore, in subjects with nasal or ocular symptoms before pollen dispersal, i.e., subjects more sensitive to pollen, a higher effect of DGLA was confirmed.

[0143] In addition, in the DGLA group at week 0 (at the start of the trial), the scores of each nasal and ocular-related item (runny nose, sneezing, nasal congestion, nasal itching, ocular itching, and tearing) of the JRQLQ were divided into those with a score of 1 or more (group H: having symptoms of mild degree or more) and those with a score of 0 (group L: having no symptoms at all), and the test results were compared.

[0144] As a result, no significant difference between the groups was found, but in all items, the mean value of group H was lower than that of group L ( Figures 9 to 14 ; runny nose, P = 0.582; sneezing, P = 0.345; nasal congestion, P = 0.126; nasal itching, P = 0.084; ocular itching, P = 0.362; and tearing, P = 0.59). Therefore, in subjects with nasal or ocular symptoms before pollen dispersal, i.e., subjects more sensitive to pollen, a higher effect of DGLA was confirmed.

[0145] In addition, in the subjects with a score of 0 for nasal itching in the JRQLQ at week 0 (group L), the mean value of the serum Cryptomeria japonica pollen-specific IgE concentration in the DGLA group at week 0 (at the start of the trial) was 1.98 AU / mL. In contrast, in the subjects with a score of 1 or more (group H), the mean value was 0.73 AU / mL, which was significantly lower than the value in the subjects with a score of 0 (group L).

[0146] Industrial applicability The present invention can provide pharmaceutical compositions, food compositions, food additives, etc. for alleviating or preventing symptoms of allergic rhinitis or allergic conjunctivitis.

Claims

1. A composition for alleviating or preventing the symptoms of allergic rhinitis or allergic conjunctivitis, characterized in that, Containing dihomo- γ -γ-linolenic acid (DGLA) as an active ingredient.

2. The composition according to claim 1, wherein, The allergic rhinitis or allergic conjunctivitis is pollinosis.

3. The composition according to claim 2, wherein, The composition is used by oral administration to a subject who has symptoms of allergic rhinitis or allergic conjunctivitis at the initial stage of pollen scattering.

4. The composition according to claim 3, wherein, In the subject, the score of at least one selected from the severity classification of allergic rhinitis symptoms, such as sneezing attack, runny nose, nasal congestion, itchy eyes, and tearing, is 1 or more at the initial stage of pollen scattering.

5. The composition according to claim 3, wherein, In the subject, the score of at least one selected from runny nose, sneezing, nasal congestion, itchy nose, itchy eyes, and tearing in the Japanese Allergic Rhinitis QOL questionnaire is 1 or more at the initial stage of pollen scattering.

6. The composition according to claim 3, wherein, The subject has a serum IgE concentration specific to Japanese cypress pollen of 0.73 UA / mL or less.

7. The composition according to any one of claims 1 to 6, wherein, The symptoms are at least one selected from sneezing attack, runny nose, nasal congestion, itchy nose, itchy eyes, and tearing.

8. The composition according to claim 7, wherein, The symptoms are at least one selected from sneezing attack, runny nose, itchy eyes, and tearing.

9. The composition according to any one of claims 1 to 8, wherein, The composition is used by oral administration to the subject at 4 mg / kg body weight / day or more of DGLA.

10. The composition according to any one of claims 1 to 9, wherein, DGLA is in any form of glyceride, phospholipid, glycolipid, alkyl ester, salt, or free fatty acid.

11. The composition according to claim 10, wherein, The glyceride is triglyceride, diglyceride, or monoglyceride.

12. The composition according to claim 10, wherein, The alkyl ester is an ester with a lower alcohol having 1 to 4 carbon atoms.

13. The composition according to claim 10, wherein, The phospholipid is diacylglycerol phospholipid or lysophosphatidylglycerol.

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