Composition for improving allergic rhinitis symptoms, composition for improving the reduction in QOL caused by allergic rhinitis symptoms, and composition for suppressing sneezing caused by allergic rhinitis symptoms

Abstract

The problem to be solved by the present invention is to provide a novel composition for improving the symptoms of allergic rhinitis. [Solution] The inventors of the present application have found through extensive research that β-carotene has the effect of improving the symptoms of allergic rhinitis. That is, by using a composition containing β-carotene as a contributing component, it is possible to improve the symptoms of allergic rhinitis, alleviate the decline in quality of life caused by allergic rhinitis, and suppress sneezing caused by allergic rhinitis.

Description

Technical Field

[0001] The present invention relates to a composition for improving allergic rhinitis symptoms, a composition for improving the reduction in QOL caused by allergic rhinitis symptoms, and a composition for suppressing sneezing caused by allergic rhinitis symptoms.

Background Art

[0002] Allergic rhinitis is a type of allergic symptom in the nasal mucosa, characterized by symptoms such as sneezing, runny nose, and nasal congestion. Allergic rhinitis has become a serious social problem because it not only reduces the quality of life (Quality of Life: QOL, hereinafter referred to as "QOL"), but also affects social activities such as learning and work. Perennial allergic rhinitis is a type of allergic rhinitis, which is caused by mites, house dust, etc., and exhibits symptoms such as sneezing, runny nose, nasal congestion, and itchy eyes throughout the year.

[0003] As symptoms of allergic rhinitis, following the production of antigen-specific IgE antibodies due to the invasion of antigens such as house dust, mites, and pollen, sneezing, runny nose, swelling of the nasal mucosa, and nasal congestion caused by the release of histamine, leukotrienes, etc. from mast cells and eosinophils are known (Non-Patent Document 1). In recent years, focusing on these mechanisms, the search for food ingredients and the development of foods that suppress allergic rhinitis symptoms have been progressing.

[0004] Patent Document 1 describes a food for preventing the onset of and / or improving the symptoms of allergic rhinitis, which contains a collagen hydrolyzate. Patent Document 2 describes a composition for suppressing the degranulation of mast cells, which contains a serotonin derivative. It is described that the serotonin derivative suppresses the reaction between an antigen and a specific IgE antibody on the cell membrane of cells such as mast cells, as well as the reaction related to the release of chemical mediators due to the degranulation of mast cells, thereby improving the symptoms of allergic rhinitis included in type I allergy (immediate allergy). Patent Document 3 describes an allergic rhinitis inhibitor characterized by containing one or more plant extracts selected from the group consisting of Euonymus alatus, Euonymus bahamensis, and Parosela.

[0005] β-carotene contained in various vegetables including carrots has been suggested to have a cancer preventive effect in epidemiological studies and is a typical functional ingredient mainly contained in plant-based foods. Regarding the relationship between β-carotene and allergic symptoms, it has been reported that administration of β-carotene suppresses the increase in antigen-specific IgE concentration in the blood and the infiltration of inflammatory cells (Non-Patent Document 2), and that β-carotene suppresses the degranulation of mast cells (Non-Patent Document 3).

[0006] Drug therapy is widely used for allergic rhinitis. However, it only provides symptomatic treatment, and there are concerns about a decrease in productivity and QOL due to recurrence within a short period if the administration is stopped, or the induction of drowsiness as a side effect. Therefore, a new composition that is safe, can be easily continued, and can obtain an effect in a relatively short period has been desired.

Prior Art Documents

Patent Documents

[0007]

Patent Document 1

Patent Document 2

Patent Document 3

Non-Patent Literature

[0008]

Non-Patent Literature 1

Non-Patent Literature 2

Non-Patent Literature 3

Summary of the Invention

Problems to be Solved by the Invention

[0009] The problem to be solved by the present invention is to provide a new composition for improving allergic rhinitis symptoms.

Means for Solving the Problems

[0010] Based on the above, what the inventor of the present application has intensively studied and found is that β-carotene has the effect of improving allergic rhinitis symptoms. That is, by using a composition containing β-carotene as a contributing component, allergic rhinitis symptoms can be improved. From this perspective, the present invention is defined as follows.

[0011] The contributing component of the composition for improving allergic rhinitis symptoms according to the present invention is β-carotene. The allergic rhinitis symptoms are at least one of eye symptoms and nasal symptoms, preferably at least one of watery eyes, sneezing, nasal itching, and nasal congestion, and more preferably sneezing.

[0012] The contributing component of the composition for improving the reduction in QOL caused by allergic rhinitis symptoms according to the present invention is β-carotene. The allergic rhinitis symptoms are at least one of eye symptoms and nasal symptoms, preferably at least one of watery eyes, sneezing, nasal itching, and nasal congestion, and more preferably sneezing. Further, the QOL is at least one of daily life, social life, and sleep.

[0013] The contributing component of the composition for suppressing sneezing caused by allergic rhinitis symptoms according to the present invention is β-carotene.

Effects of the Invention

[0014] What the present invention enables is to provide a new composition for improving allergic rhinitis symptoms. Further, what the present invention enables is to provide a composition for improving the reduction in QOL caused by allergic rhinitis and a composition for suppressing sneezing caused by allergic rhinitis.

Brief Description of the Drawings

[0015]

Figure 1

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Figure 8

Mode for Carrying Out the Invention

[0016] <Allergic Rhinitis> The "allergic rhinitis" of the present invention is a disease in which a type I allergic reaction, that is, an IgE-dependent reaction, occurs in the nasal mucosa. The symptoms of allergic rhinitis are recurrent sneezing, rhinorrhea (watery), nasal congestion, etc. Allergic rhinitis is a pure allergy that depends on IgE, and symptoms appear only in the local area (near the nose and eyes) where allergens adhere. Allergic rhinitis is divided into perennial allergic rhinitis and seasonal allergic rhinitis. Seasonal allergic rhinitis includes hay fever.

[0017] <Composition for Improving Allergic Rhinitis Symptoms> The composition for improving allergic rhinitis symptoms according to the present invention contains β-carotene as a contributing component and is excellent in the action of suppressing allergic rhinitis symptoms. The allergic rhinitis symptoms are at least one of eye symptoms and nose symptoms. The allergic rhinitis symptoms are preferably at least one of watery eyes, sneezing, nasal itching, and nasal congestion, and more preferably sneezing.

[0018] <Composition for improving the quality of life (QOL) caused by allergic rhinitis symptoms> The composition for improving the QOL caused by allergic rhinitis symptoms according to the present invention contains β-carotene as a contributing component and has an effect of improving the decrease in QOL caused by allergic rhinitis symptoms. The allergic rhinitis symptoms are at least one of eye symptoms and nasal symptoms. The allergic rhinitis symptoms are preferably at least one of watery eyes, sneezing, nasal itching, and nasal congestion, and more preferably sneezing. Also, the details of the QOL are at least one of daily life, social life, and sleep. The composition for improving the QOL caused by allergic rhinitis symptoms according to the present invention is one of the embodiments of the composition for improving allergic rhinitis symptoms described above.

[0019] <Composition for suppressing sneezing caused by allergic rhinitis symptoms> The composition for suppressing sneezing caused by allergic rhinitis symptoms according to the present invention contains β-carotene as a contributing component and has an effect of suppressing sneezing caused by allergic rhinitis symptoms. The composition for suppressing sneezing caused by allergic rhinitis symptoms according to the present invention is one of the embodiments of the composition for improving allergic rhinitis symptoms described above.

[0020] <β-carotene> β-carotene is not particularly limited and may be a natural component or a synthesized one. When β-carotene is added as a natural component, it may be added in the form of carrots containing β-carotene, their squeezed juices, algae, etc., or β-carotene extracted and purified from these raw materials may be added.

[0021] <Contributing component> A contributing component refers to a substance whose affected target is the physiological functionality of the body. What corresponds to the contributing component in foods for specified health use and foods with functional claims is the so-called "involved component" and "functional involved component". In the case of pharmaceuticals and quasi-drugs, it is the so-called "active ingredient".

[0022] <Administration / Intake Forms of the Composition According to the Present Invention> The composition for improving allergic rhinitis symptoms, the composition for improving the decline in QOL caused by allergic rhinitis symptoms, and the composition for suppressing sneezing caused by allergic rhinitis symptoms described above will be described as the composition according to the present invention. The composition according to the present invention includes a pharmaceutical composition and a food composition. Details will be described later.

[0023] In the composition according to the present invention, β-carotene may be 4.0 mg or more per day, preferably 4.2 mg or more, more preferably 4.4 mg or more, and even more preferably 4.7 mg or more, and it is preferably administered or ingested. This amount per day can be administered or ingested once or divided into several times, and the timing can be any of before meals, after meals, and between meals.

[0024] As described later in the examples, it has been confirmed that by administering or ingesting a composition containing 4.0 mg or more of β-carotene per day to subjects, an improvement effect on allergic rhinitis symptoms can be observed.

[0025] There is no particular upper limit for the administration amount or intake amount of β-carotene per day, but excessive intake may cause health problems. Therefore, the upper limit of the administration amount or intake amount of β-carotene is 15 mg per day, preferably 10 mg per day, and more preferably 6 mg per day.

[0026] The administration period or intake period of the composition of this embodiment may be 4 weeks or more, preferably 6 weeks or more, and more preferably 8 weeks or more. As described later in the examples, by continuously administering or ingesting the composition according to the present invention for 4 weeks or more, the improvement effect on allergic rhinitis tends to become more prominent.

[0027] <Pharmaceutical Composition> The composition according to the present invention may be a pharmaceutical composition containing β-carotene and a pharmaceutically acceptable carrier. The above pharmaceutical composition is preferably administered orally and is preferably formulated into a dosage form for oral use. Examples of dosage forms for oral use include tablets, capsules, elixirs, microcapsules, and the like. Examples of pharmaceutically acceptable carriers include binders such as gelatin, corn starch, tragacanth gum, and gum arabic; excipients such as starch and crystalline cellulose; swelling agents such as alginic acid, and the like.

[0028] The pharmaceutical composition of this embodiment may contain additives. Examples of additives include lubricants such as calcium stearate and magnesium stearate; sweeteners such as sucrose, lactose, saccharin, and maltitol; flavoring agents such as peppermint and Perilla oil; stabilizers such as benzyl alcohol and phenol; buffers such as phosphates and sodium acetate; solubilizing agents such as benzyl benzoate and benzyl alcohol; antioxidants; preservatives, and the like.

[0029] The pharmaceutical composition of this embodiment can be formulated by appropriately combining the above carriers and additives and mixing them in a unit dosage form required for generally recognized pharmaceutical practice. The pharmaceutical composition of this embodiment may be formulated, for example, for oral administration once a day.

[0030] <Food Composition> The composition according to the present invention provides a food composition containing β-carotene as a contributing component. As will be described later in the examples, by ingesting the food composition of this embodiment, allergic rhinitis symptoms can be improved in humans or animals.

[0031] The shape and properties of food and beverages, feeds, etc. containing the food composition of this embodiment are not particularly limited, and examples include solid, semi-solid, gel-like, liquid, powdery, and the like.

[0032] The food composition of the present embodiment may be in the form of, for example, a supplement, a beverage, a gel food, or any form of cooked food. The shape of the supplement is not limited, and examples include shapes such as capsules. When making a beverage, vegetable beverages and vegetable-fruit beverages can be preferably selected.

[0033] <Food with Functional Claims> The food composition of the present embodiment may be a food with functional claims. "Food with functional claims" means a food notified to the Consumer Affairs Agency that displays its functionality on the product package based on scientific evidence. Examples of such displays include, but are not limited to, "relieves nasal discomfort caused by pollen, dust, house dust, etc.", "relieves discomfort in the eyes and nose caused by house dust or dust, etc.", "for those with allergic reactions in the nose and eyes", etc. Also, even for foods without functional claims, it is conceivable to manufacture and sell them while promoting these functions through flyers, emails, or orally. As will be described later in the examples, it has been confirmed that by ingesting the food composition of the present embodiment, allergic rhinitis symptoms are improved.

[0034] <Foods for Special Dietary Uses> The food composition of the present embodiment may be a food for special dietary uses. "Foods for special dietary uses" means foods that are displayed as having special uses suitable for the growth, health maintenance, and recovery of infants, young children, pregnant and lactating women, patients, etc., after obtaining national permission.

[0035] The food composition of the present embodiment may be a food for patients among the foods for special dietary uses. As will be described later in the examples, it has been confirmed that the food composition of the present embodiment has an effect of improving allergic rhinitis.

[0036] The food composition of the present embodiment may be a food for specified health use among special-purpose foods. A food for specified health use means a food that is recognized based on scientific grounds as being useful for maintaining and promoting health, and for which the display of its effects is permitted. The state conducts reviews on the displayed effects and safety, and each food is permitted by the Commissioner of the Consumer Affairs Agency. As will be described later in the examples, the food composition of the present embodiment has been confirmed to have an effect of improving allergic rhinitis symptoms.

Examples

[0037] Next, examples will be shown to explain the present invention in more detail, but the present invention is not limited to the following examples.

Examples

[0038] Using allergic rhinitis model mice, the allergic rhinitis symptoms were evaluated.

[0039] <Test food> β-carotene (Sigma-Aldrich: C9750) was prepared at 0.48 mg / mL and 4.8 mg / mL using corn oil (Wako Pure Chemical Industries: WDL0579) as a medium, and a carrot concentrate (RD2 International) containing 0.48 mg / mL of β-carotene was used.

[0040] <Test method> Using 40 six-week-old BALB / c (female) (Japan SLC), allergic rhinitis model mice derived from OVA antigen were created, and the efficacy of β-carotene was evaluated. After one week of acclimation, as shown in Table 1, 40 mice were randomly divided into 5 groups of 8 each (non-sensitized group, sensitized group, high-dose β-carotene group, low-dose β-carotene group, carrot juice group). The groups are designated as Control 1, Control 2, and Groups 1 to 3 in order.

[0041] Intakes other than the test food were commercially available solid feed (Funabashi Farm: FR-2) and tap water, and both were allowed to be freely ingested.

[0042]

Table 1

[0043] The grouping day was set as day 0. For the sensitized control 2 and groups 1 to 3 in Table 1 above, primary sensitization and secondary sensitization were performed. The primary sensitization was carried out using an OVA antigen suspension. The OVA antigen suspension was prepared by mixing ovalbumin (Sigma-Aldrich: SLBD2313V) at 100 μg / mL and Imject Alum (Thermo Fisher Scientific: SLBD2313V) at 20 mg / mL in PBS (Wako Pure Chemical Industries, Ltd.: DSH7009). The OVA antigen suspension was subcutaneously administered at 200 μL per mouse near the tail root under anesthesia on days 15, 22, and 29. Only PBS was subcutaneously administered in the same amount to the non-sensitized group of control 1.

[0044] For the four groups after the primary sensitization, the secondary sensitization was performed using an NAC solution and an OVA antigen solution. The NAC solution was prepared by dissolving N-acetyl-L-cysteine (WEF3303, Wako Pure Chemical Industries, Ltd.) in distilled water at 15 mg / mL. The OVA antigen solution was prepared by dissolving ovalbumin in PBS at 2 mg / mL. On days 31, 33, 35, 38, 41, 44, and 48, 10 μL of the NAC solution was instilled into both nostrils, and about 5 minutes later, the nostrils were washed twice with PBS (10 μL) per nostril, and then 10 μL of the OVA antigen solution was instilled into both nostrils. Only PBS was instilled into both nostrils in the same amount in the non-sensitized group of control 1.

[0045] Oral administration of β-carotene was carried out using a disposable oral sonde and a syringe from the day of grouping until day 49, excluding the blood sampling day and the primary sensitization day, between 8:00 am and 11:00 am every day. Only corn oil was orally administered to control 1 and control 2.

[0046] <Number of sneezes> The number of sneezes was measured by video recording for 5 minutes after the secondary sensitization on days 35, 41, and 48. Figure 1 shows the values of the mean ± standard error of the number of sneezes (on days 35, 41, and 48) of OVA-sensitized allergic model mice administered with β-carotene and carrot juice for 49 days. One-way ANOVA was performed for comparison among the 4 groups excluding Control 1, and the Tukey-Kramer test was used as the post hoc test (*: P<0.05, **: P<0.01). For comparison between Control 1 and Control 2, the Aspin Welch t-test was used ($$: P<0.01).

[0047] <Results> On all measurement days, the number of sneezes in Sensitized Control 2 was significantly increased compared to Unsensitized Control 1. On the measurement day of day 35, no significant difference was observed between Control 2 and Groups 1 to 3, but the number of sneezes in Group 1 was significantly less than that in Group 3. On the measurement day of day 41, the number of sneezes in Groups 1 to 3 was significantly less than that in Control 2. Also, on the measurement day of day 48, the number of sneezes in both Groups 1 and 2 was significantly less than that in Control 2. Group 3 showed a tendency to be less than Control 2 (P = 0.087).

[0048] <Amount of OVA antigen-specific IgE in blood> The amount of OVA antigen-specific IgE in plasma was measured on days 0, 41, and 50. Figure 2 shows the mean + standard error of the amount of OVA antigen-specific IgE in plasma of OVA-sensitized allergic model mice administered with β-carotene and carrot juice for 49 days, measured (a) on day 41 and (b) on day 50. One-way ANOVA was performed for comparison among the 4 groups excluding Control 1, and the Tukey-Kramer test (*: P<0.05) was used as the post hoc test. For comparison between Control 1 and Control 2, the Aspin Welch t-test was used ($$: P<0.01).

[0049] <Results> The amount of OVA antigen-specific IgE on day 0 (before sensitization) was 0.00±0.00, 0.00±0.00, 0.37±0.37, 0.20±0.19, and 0.04±0.04 (a.u.) in Control 1, Control 2, Group 1, Group 2, and Group 3, respectively. "a.u." is an abbreviation for Arbitrary Unit, which is an arbitrary unit. On both measurement days, the amount of OVA antigen-specific IgE in Control 2 was significantly increased compared to Control 1. Also, on both measurement days, no significant difference was observed between Control 2 and Groups 1 to 3, but Group 1 showed a significantly lower value of OVA antigen-specific IgE compared to Group 3.

Example

[0050] A randomized double-blind placebo-controlled parallel-group comparison study was conducted as follows.

[0051] <Selection of study subjects> Only those who gave written informed consent based on their free will were considered as candidates for study subjects. A total of 40 study subjects, 20 in each group, were recruited. Among them, 40 subjects who met the following selection criteria and were not judged as ineligible as study subjects by the principal investigator or the sub-investigator, etc., were selected as study subjects.

[0052] <Selection criteria> The selection criteria were: (1) healthy Japanese men and women who had not received treatment or medication, (2) those aged 20 or older and 59 or younger at the time of obtaining consent, (3) those with subjective symptoms of perennial allergic rhinitis classified as mild to moderate, (4) those positive for specific IgE (mites or house dust) in a blood allergy test, and (5) those judged as eligible by the principal investigator or the sub-investigator.

[0053] <Grouping of study subjects> The study subjects were stratified by age, sex, and nasal symptoms. Regarding nasal symptoms, they were stratified using the severity classification score based on the "Guidelines for the Diagnosis and Treatment of Nasal Allergies - Perennial Rhinitis and Hay Fever -" (Life Science Co., Ltd.: 2020 Edition (Revised 9th Edition)) and the score of the Japanese Standard QOL Questionnaire for Allergic Rhinitis (hereinafter referred to as "JRQLQ"). Then, using the random number generation method, they were randomly divided into two groups: a placebo food intake group (placebo group) and a test food intake group (β-carotene group), with 20 subjects in each group. Note that the blinding was applied to all those involved in the study, and the allocation table was kept locked until the analysis subjects were fixed.

[0054] <Test food> A vegetable and fruit mixed juice containing β-carotene (raw materials: carrot, apple, citric acid, flavor, 200 mL / bottle) was used as the test food, and a vegetable and fruit mixed juice without β-carotene (raw materials: carrot, apple, lemon, citric acid, flavor, 200 mL / bottle) was used as the placebo food. The nutritional components per bottle of the test food and the placebo food are shown in Table 2. Note that the test food and the placebo food were manufactured in plain white containers so that the test implementers and the study subjects could not distinguish them visually. The nutritional components per bottle of the test food and the placebo food are shown in Table 2. Note that the test food and the placebo food were manufactured in plain white containers so that the test implementers and the study subjects could not distinguish them visually.

[0055]

Table 2

[0056] <Test method> All study subjects were made to ingest one bottle of the test food every day during the test food intake period. The severity classification score was recorded every day from the start date of the pre-test observation until the completion of the test food intake. The JRQLQ questionnaire was filled out six times at -3, 0, 2, 4, 6, and 8 weeks of the test food intake. Also, the following restrictions were observed during the test period.

[0057] <Restrictions> The restrictions are as follows: (1) During the test period, record the necessary items in the log every day. (2) Maintain the same lifestyle (diet, exercise, sleep) as before the test and avoid irregular lifestyles (overeating, excessive dieting, staying up all night, etc.). (3) Refrain from using new pharmaceuticals, oral quasi-drugs, traditional Chinese medicine, and health foods (including supplements). However, if it is necessary to use them, record the details in the lifestyle log. (4) Continue to use the current quasi-drugs, traditional Chinese medicine, and health foods (including supplements) without changing the dosage and usage method. If there is a change, record it in the lifestyle log. (5) Prohibit the intake of health foods that claim anti-allergic effects, the use of health foods (including supplements) with high carotenoid content, and the intake of vegetable juice and vegetable-fruit mixed juice. (6) Restrict the intake of foods rich in beta-carotene. (7) Prohibit alcohol intake and strenuous exercise on the day before blood sampling. (8) From 9:00 p.m. on the day before blood sampling until blood sampling the next morning, prohibit eating and drinking except for water or plain boiled water. (9) Prohibit participating in clinical trials using other test foods, pharmaceuticals, quasi-drugs, cosmetics, etc. (10) During the test period, prohibit blood sampling of 200 mL or more (such as blood donation). (11) Prohibit leaking information about the test to third parties other than the relevant persons and posting / listing it on the WEB such as SNS. (12) In addition, follow the instructions of the responsible physician and the participating physicians of the test.

[0058] <Evaluation Method> As the main evaluation items, four nasal items for severity classification (sneezing, nasal discharge, nasal congestion, nasal symptoms) and six nasal items of JRQLQ (runny nose, sneezing, nasal blockage, nasal itching, nasal symptoms, eye-nose symptoms) were evaluated. The severity classification score was recorded daily on a five-point scale of 0 (no symptoms), 1 (mild), 2 (moderate), 3 (severe), and 4 (most severe) for the condition of that day. The daily recorded values were averaged every three weeks during the pre-observation period and every two weeks during the test food intake period and used for analysis. For JRQLQ, look back at the two weeks before the recording date every two weeks and record the state at the time of the most severe symptoms on a five-point scale of 0 (no symptoms), 1 (mild), 2 (slightly mild), 3 (severe), and 4 (very severe), and use the value for analysis.

[0059] As secondary evaluation items, three items of severity classification (eye itching, tearing, eye symptoms), three items of JRQLQ (eye itching, watery eyes, eye symptoms), and eight QOL items of JRQLQ (daily life, outdoor life, social life, sleep, physical function, mental life, overall, general condition) were evaluated.

[0060] <Statistical analysis> For the between-group comparison of the measured values and the amount of change at each week, the Mann-Whitney U test was used, and for the within-group comparison with week 0, the Wilcoxon signed-rank test considering multiplicity by Bonferroni correction was used. All tests were performed at a significance level of 5%. EZR (EZR Version 1.40, R Commander Version 2.5-1) and SPSS (Ver.15.0J) were used as statistical analysis software. In addition, each evaluation item was expressed as the mean ± standard deviation. In Figures 3 to 5, *: p < 0.05 was assigned to the values showing a significant difference in the comparison between the β-carotene group and the placebo group, and †: p < 0.05, ††: p < 0.01 were assigned to the values showing a significant difference in the comparison with week 0 of test food intake.

[0061] <Results> The measured values of the severity classification scores of the eyes and nose and the amount of change (Δ value) from week 0 of test food intake are shown in Figure 3. In the severity classification score of the nose, no significant difference was confirmed between the β-carotene group and the placebo group in both the measured value and the amount of change. On the other hand, in the comparison with week 0 of test food intake, only the β-carotene group showed significantly lower values in sneezing (at 6 and 8 weeks of intake) and nasal congestion (at 8 weeks of intake). In the severity classification score of the eyes, no significant difference was confirmed between the β-carotene group and the placebo group in both the measured value and the amount of change. On the other hand, in the comparison with week 0 of test food intake, only the β-carotene group showed significantly lower values in eye itching and eye symptoms (both at 8 weeks of intake).

[0062] The measured values of the nasal and ocular symptoms of JRQLQ and the amount of change (Δ value) from 0 weeks of test food intake were shown in Figure 4. In terms of the nasal score, the β-carotene group showed significantly lower values in nasal and ocular symptoms (at 6 weeks of intake) compared to the placebo group. Also, when compared with 0 weeks of intake, only the β-carotene group showed significantly lower values in sneezing (at 6 and 8 weeks of intake), nasal itching (at 8 weeks of intake), nasal symptoms (at 8 weeks of intake), and nasal and ocular symptoms (at 2, 6, and 8 weeks of intake). In terms of the ocular score, the β-carotene group showed significantly lower values in watery eyes (at 8 weeks of intake) and ocular symptoms (at 6 and 8 weeks of intake) compared to the placebo group.

[0063] The measured values of the QOL score of JRQLQ and the amount of change (Δ value) from 0 weeks of test food intake were shown in Figure 5. The β-carotene group showed significantly lower values in daily life (at 8 weeks of intake) compared to the placebo group. Also, when compared with 0 weeks of intake, only the β-carotene group showed significantly lower values in mental life (at 4, 6, and 8 weeks of intake) and overall (at 6 and 8 weeks of intake).

Example

[0064] A randomized double-blind placebo-controlled parallel-group comparison trial was conducted as follows.

[0065] <Selection of research subjects> A total of 96 research subjects, 48 in each group, were recruited. Excluding those who did not meet the following selection criteria and those who were judged ineligible as research subjects by the principal investigator or sub-investigator, etc., the 96 subjects who were selected were used as research subjects.

[0066] <Selection criteria> The selection criteria were: (1) healthy Japanese men and women who have not received treatment or medication, (2) those aged 20 or older and 59 or younger at the time of obtaining consent, (3) those with subjective symptoms of perennial allergic rhinitis classified as mild to moderate, (4) those with positive or suspected positive serum specific IgE (either mite or house dust) in the allergy test at the pre-examination, and (5) those judged eligible by the principal investigator or sub-investigator.

[0067] <Grouping of the study subjects> Ninety-six subjects selected as the study subjects were stratified by age, sex, and nasal symptoms (severity classification score). Subsequently, using a random number generation method, they were randomly divided into two groups: a placebo food intake group (placebo group) and a test food intake group (β-carotene group), with 48 subjects in each group. Note that the blinding was applied to all those involved in the study, and the allocation table was kept under lock until the analysis subjects were fixed.

[0068] <Test food> A vegetable and fruit mixed juice containing β-carotene (raw materials: carrot, apple, citric acid, flavor, 195 mL / bottle) was used as the test food, and a vegetable and fruit mixed juice without β-carotene (raw materials: carrot, apple, lemon, citric acid, flavor, 195 mL / bottle) was used as the placebo food. The nutritional components per bottle of the test food and the placebo food are shown in Table 3. The manufacturing method and the management method were carried out in the same manner as in Example 2.

[0069]

Table 3

[0070] <Test method> All the study subjects were made to ingest one bottle of the test food every day during the test food intake period. The severity classification score was recorded every day from the start date of the pre-test observation until the completion of the test food intake. The JRQLQ questionnaire was filled out six times at -6, 0, 2, 4, 6, and 8 weeks during the test food intake. Also, during the test period, the same restrictions as in Example 2 were observed.

[0071] <Evaluation method> As the main evaluation items, four nasal items of the severity classification (sneezing, nasal discharge, nasal congestion, nasal symptoms) were evaluated. The severity classification score used the value recorded in the daily log averaged over two weeks during the pre-observation period and every two weeks during the test food intake period.

[0072] As secondary evaluation items, the 6 nasal items of JRQLQ (runny nose, sneezing, nasal congestion, nasal itching, nasal symptoms, eye-nose symptoms), the 3 eye items of severity classification (eye itching, tearing, eye symptoms), the 3 eye items of JRQLQ (eye itching, watery eyes, eye symptoms), and the 8 QOL items of JRQLQ (daily life, outdoor life, social life, sleep, physical function, mental life, overall, general condition) were evaluated.

[0073] <Statistical analysis> For the between-group comparison of the measured values and the amount of change at each week, the Mann-Whitney U test was used, and for the within-group comparison with week 0, the Wilcoxon signed-rank test considering multiplicity by Bonferroni correction was used. All tests were performed at a significance level of 5%. EZR (EZR Version 1.40, R Commander Version 2.5-1) and SPSS (Ver.15.0J) were used as statistical analysis software. In addition, each evaluation item was expressed as the mean ± standard deviation. In Figures 6 to 8, *: p < 0.05 was attached to the values showing a significant difference in the comparison between the β-carotene group and the placebo group, and †: p < 0.05, ††: p < 0.01, and †††: p < 0.001 were attached to the values showing a significant difference in the comparison with week 0 of test food intake.

[0074] <Results> The measured values of the severity classification score and the amount of change (Δ value) from week 0 of test food intake are shown in Figure 6. In the nasal severity classification score, a significant decrease was confirmed in the amount of change in nasal discharge and nasal symptoms (both at 2 weeks of intake) in the β-carotene group compared with the placebo group. In the eye severity classification score, no significant difference was confirmed between the β-carotene group and the placebo group in either the measured value or the amount of change. On the other hand, in the comparison with week 0 of intake, significant improvement was confirmed in all 3 items of eye itching, tearing, and eye symptoms in both the β-carotene group and the placebo group.

[0075] The measured values of the nasal and ocular symptoms of JRQLQ and the change amounts (Δ values) from 0 weeks of test food intake were shown in Fig. 7. In terms of the nasal score, the β-carotene group showed a significantly lower value in the change amount of sneezing (at 8 weeks of intake) compared with the placebo group. Also, when compared with 0 weeks of intake, only the β-carotene group showed significantly lower values in sneezing (at 4, 6, and 8 weeks of intake), nasal congestion (at 8 weeks of intake), and nasal itching (at 6 and 8 weeks of intake). Also, although the placebo group also showed significantly lower values, the β-carotene group also showed significantly lower values in nasal symptoms and nasal and ocular symptoms (both at 4, 6, and 8 weeks of intake). In terms of the ocular score, no significant difference was confirmed between the β-carotene group and the placebo group in either the measured value or the change amount. On the other hand, although the placebo group also showed significantly lower values, the β-carotene group also showed significantly lower values in watery eyes (at 4, 6, and 8 weeks of intake) and ocular symptoms (at 6 and 8 weeks of intake).

[0076] The measured values of the QOL of JRQLQ and the change amounts (Δ values) from 0 weeks of test food intake were shown in Fig. 8. The β-carotene group showed significantly lower values in social life and sleep (both at 8 weeks of intake) compared with the placebo group. Also, when compared with 0 weeks of intake, only the β-carotene group showed significantly lower values in outdoor life, social life, sleep, mental life (all at 8 weeks of intake), and overall (at 8 weeks of intake). On the other hand, although the placebo group also showed significantly lower values, the β-carotene group also showed significantly lower values in daily life (at 6 and 8 weeks of intake) and overall status (at 6 and 8 weeks of intake).

Industrial Applicability

[0077] The field where the present invention is useful is the field of health foods.

Claims

1. A composition for improving the reduction of QOL caused by allergic rhinitis symptoms, wherein the QOL is at least one of social life and sleep, and its contributing component is β-carotene, and the β-carotene contained in the composition is 4.0 mg or more and 15 mg or less as the daily intake.

2. The composition according to Claim 1, wherein the allergic rhinitis symptoms are at least one of eye symptoms and nasal symptoms.

3. The composition according to Claim 1 or 2, wherein the allergic rhinitis symptoms are at least one of watery eyes, sneezing, nasal itching, and nasal congestion.

4. The composition according to any one of Claims 1 to 3, wherein the allergic rhinitis symptom is sneezing.

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