Healthy adults.
Conditions
Interventions
The subjects take Kumquat "
five pieces per day for four weeks
The subjects don'
t take Kumquat "
Sponsors
University of Miyazaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who are judged as healthy by self-reported health questionnaire. 2. Subjects who are 35-55 years old at informed consent. 3. 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 don't fill any item of self-reported health questionnaire. 2. Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular and/or mental disease, or who have history of those diseases on self-reported health questionnaire. 3. Subjects who have a serious injury or surgical history within 12 weeks prior to this study. 4. Pre- or post-menopausal women having obvious changes in physical condition. 5. Subjects who are at risk of having allergic reaction to citrus foods including kumquat. 6. Subjects who have history of allergic reaction to foods or drugs which needs its treatment or who have possibility of the reaction. 7. Subjects who are heavy smoker (more than 21 cigarettes per day), alcohol dependency or drug dependency or who have possibility of these dependency. 8. Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study. 9. Pregnant or lactating women or women 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 before this study. 12. Subjects who are judged as unsuitable for this study by the principal investigator or subinvestigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total score of Chalder fatigue scale at first day, four weeks and eight weeks after ingestion of ripe kumquats. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. VAS score 2. QOL scales (SF-36) 3. Symptom scores of upper respiratory tract infections(URTI) 4. Duration of illness, the number of days from the onset to the complete disappearance of URTI symptoms 5. Percentage of visiting physicians due to symptoms of URTI 6. Incidence rate of influenza 7. Restriction of daily activities 8. Adverse events (VAS score and QOL scales are assessed on the first day, four weeks and eight weeks after ingestion of ripe kumquats "Tama-Tama".) | — |
Countries
Japan
Contacts
Public ContactYasuji Arimura
University of Miyazaki Clinical research support center, University of Miyazaki hospital
Outcome results
None listed