N/A(healthy adults)
Conditions
Interventions
Oral ingestion of the test food (2 capsules once a day for 12 weeks).
Oral ingestion of the placebo food (2 capsules once a day for 12 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Japanese males and females aged 20-64 years. [2]Individuals who are healthy and are not suffered from a chronic malady. [3]Individuals with allergic reaction of eyes and nose in early spring. [4]Individuals whose written informed consent has been obtained. [5]Individuals who can visit an inspection facility and be inspected in designated days. [6]Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1]Individuals using medical products. [2][2]Individuals who use an antiallergic drug or steroid drug or will use during the test period. [3]Individuals who have history of intranasal laser therapy to reduce allergic symptoms. [4]Individuals who are a patient of or have a history of bronchial disease. [5]Individuals who are patient or have a history of mental disease, psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [6]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [7]Individuals who are sensitive to other foods and medical products. [8]Individuals who contract or have a history of serious hepatopathy, kidney damage, heart disease and blood disease. [9]Individuals who are a patient or have a history of or endocrine disease. [10]Individuals whose BMI is over 30 kg/m2. [11]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [12]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements containing similar composition with a test food in the past 1 month or will ingest those foods during the test period. [13]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 1 months or will ingest those foods during the test period to reduce allergic symptoms. [14]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60 mg/day). [15]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [16]Individuals who are or are possibly, or are lactating. [17]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [18]Individuals who are or whose family is engaged in healthy or functional foods. [19]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Indexes for allergic rhinitis (Japan Rhinitis Quality of Life Questionnaire No. 1(1), grading the severity of allergic rhinitis(2), grading of local findings(2), eyes and nose condition based on subject's diary(3), effect measurement(4)) (1):Week 0, 2, 4, 6, 8, 10, 12. (2):Week 0, 6, 12. (3)From the first day of ingestion of a test material to the last day of the test. (4)Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes [1]Specific measurementf of nasal discharge and blood (nasal discharge eosinophils(1), eosinophil(1), nonspecific IgE(1), specific IgE(2)). (1):Week 0, 6, 12. (2):Week 0, 12. *Safety evaluation [1]Hematologic test(1). [2]Blood biochemical test(1). [3]Urine analysis(1). [4]Blood pressure, pulsation(1). [5]Weight, body fat percentage, BMI(1). [6]Doctor's questions(1). (1):Week 0, 6, 12. *Other indexes [1]Questionnaire for allergic rhinitis(1). [2]Subject's diary(2). (1):Week 0. (2)From the first day of ingestion of a test material to the last day of the test. | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed