Effect of Daily Intake of Test Food on Skin Function : A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
- Conditions
- Healthy Adult
- Registration Number
- JPRN-UMIN000044815
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 80
Not provided
1. Subjects who has symptoms of atopic dermatitis. 2. Subjects with a clinical history of gastrointestinal cancer or currently under treatment or anti-tumor medication. 3. Subjects with gastrointestinal disorders such as inflammatory bowel syndrome, irritable bowel syndrome, etc. 4. Subjects who has significant abnormal skin condition at the test site. 5. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 6. Subjects with major surgical history relevant to the digestive system. 7. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 8. Subjects with severe anemia. 9. Pre- or post-menopausal women complaining of obvious physical changes. 10. Subjects who are at risk of having allergic reactions to drugs or foods. 11. Subjects who could have a seasonal allergy during this study. 12. Subjects who use gastrointestinal drugs or female hormone once or more a week. 13. Subjects who regularly take functional foods and/or supplements which potentially affect bowel movements. 14. Subjects who regularly take fiber reinforced food and/or yogurt. 15. Subjects who have used or will use antimicrobials between 12 weeks prior to study entry and the end of the study. 16. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 17. Subjects who donated either 400 ml whole blood within 16 weeks, 200 ml whole blood within 4 weeks, or blood components within 2 weeks, prior to the study. 18. Pregnant or lactating women or women who expect to be pregnant during this study. 19. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the study. 20. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Skin measurement at 4 weeks and 8 weeks after beginning the intake of test food.
- Secondary Outcome Measures
Name Time Method Intestinal flora, stool inspection, VAS questionnaire on skin, bowel diary, survey on subjects' sleeping and mental and physical conditions, blood test, heart rate variability.