Effect of Daily Ingestion of Apple on Improving Minor Ailments: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000043101
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
1. Subjects who are under treatment or medication for schizophrenia, depression, mania, nervous disorder or chronic fatigue syndrome. 2. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal or affected with infectious diseases which is required to report to the authorities. 3. Subjects who have a major surgical history such as gastrectomy, gastrorrhaphy, enterectomy or other serious gastrointestinal surgeries. 4. Subjects with unusually high and/or low blood pressure, abnormal physical data and/or abnormal hematological data. 5. Subjects with severe anemia. 6. Pre- or post-menopausal women complaining of obvious physical changes. 7. Subjects who are at risk of having allergic reactions to drugs, foods (especially birch pollen, apples, peaches, pears, cherries, strawberries, plums and apricots). 8. Subjects who eat apples frequently. 9. Subjects who regularly take health foods and/or supplements containing polyphenols. 10. Subjects who regularly take foods fortified with oligosaccharides and/or dietary fiber, yogurt, cultured milk drink, and natto. 11. Subjects who took antibacterial drugs within 12 weeks before the start of ingestion. 12. Heavy smokers, alcohol addicts or subjects with irregular lifestyle. 13. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks, or blood components within 2 weeks, prior to the current study. 14. Pregnant or lactating women or women who expect to be pregnant during this study. 15. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 16. Subjects determined to be ineligible by the principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VAS questionnaire on fatigue at 2 weeks after beginning the intake of test food.
- Secondary Outcome Measures
Name Time Method Intestinal flora, heart rate variability, electroencephalogram during sleeping, sleeping record, survey on subjects' sleeping and mental and physical conditions, urinary metabolites, urinary 8OHdG.