Healthy adults
Conditions
Interventions
The subjects take dried powdered asparagus 10g per day for 8 weeks.
The subjects take placebo food 10g per day for 8 weeks.
Sponsors
University of Miyazaki
Industrial Technology Center of Saga
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who are judged as healthy by self-reported health questionnaire. 2. Subjects who have regular nasal or ocular discomfort (responded with any of the symptoms in "I. Nasal and Ocular Symptoms" on the JRQLQ No. 1) and who do not regularly use medicines for symptom relief. 3. Subjects who have no clinical abnormality by screening tests. 4. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Exclusion criteria
Exclusion criteria: 1.Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular, dermatological, and/or mental disease, or who have history of those disease. 2.Subjects who have a serious injury or surgical history within 12weeks prior to this study. 3.Pre-or post-menopausal women having obvious changes in physical condition. 4. Subjects who unable to ingest asparagus. 5.Subjects who have history of allergic reaction to foods or drugs which needs its treatment or who have possibility of the reaction. 6. Heavy smokers (more than 21 cigarettes per day), alcohol addicts (more than 80g per day alcohol), subjects who are alcohol or drug dependence, subjects who are suspected of alcohol or drug dependence. 7.Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study. 8.Subjects donate either 400ml or 200ml whole blood or blood component within four weeks prior to this study or subjects who plan to donate blood during this study. 9. Subjects who are pregnant or lactating, or subjects who expect to be pregnant during this study. 10.Subjects who have cognitive disorder or who have possibility of the disorder. 11.Subjects who participate and take the study drug in other clinical trials within four weeks prior to this study. 12.Subjects who are judges as unsuitable for this study by the principal investigator or subinvestigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the total score of nasal and ocular symptoms on the Japanese Standard Quality of Life Questionnaire for Allergic Rhinitis (JRQLQ) No. 1 before and after ingestion of dried powdered asparagus or placebo food for 8 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The actual value and the change of total score of nasal and ocular symptoms on the JRQLQ No. 1 before and after ingestion of dried powdered asparagus or placebo food for 8 weeks (Other than primary endpoint). 2. The actual value and the change of scores for each of nasal and ocular six symptoms on the JRQLQ No. 1 before and after ingestion of dried powdered asparagus or placebo food for 8 weeks. 3. The actual value and the change of total QOL score, scores for each of the six domain(daily living, outdoor activities, social life, sleep, physical, and mental life) on the JRQLQ No. 1 before and after ingestion of dried powdered asparagus or placebo food for 8 weeks. 4. The actual value and the change of overall state score on the JRQLQ No. 1 before and after ingestion of dried powdered asparagus or placebo food for 8 weeks. 5. The actual value and the change of nonspecific and specific IgE levels before and after ingestion of dried powdered asparagus or placebo food for 8 weeks. 6. The actual value and the change of Pperipheral blood eosinophils count before and after ingestion of dried powdered asparagus or placebo food for 8 weeks. 7. The actual value and the change of metabolic syndrome related index (BMI, body weight, glucose, HbA1c, LDL-cholesterol, HDL-cholesterol, and triglyceride) before and after ingestion of dried powdered asparagus or placebo food for 8 weeks. 8. The actual value and the change of scores for each of the eight domains and two summary scores on SF-8 before and after ingestion of dried powdered asparagus or placebo food for 8 weeks. 9. Adverse events | — |
Countries
Japan
Contacts
Public ContactYasuji Arimura
University of Miyazaki Department of Health Care Research, University of Miyazaki (Kiyotake Branch)
Outcome results
None listed