Effect of Daily Ingestion of test beverage containing extract of koji-fermented food on improving physical-mental minor complaints: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
- Conditions
- Healthy Adult
- Registration Number
- JPRN-UMIN000042404
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 20
Not provided
1.Subjects with a clinical history of gastrointestinal cancer or currently under treatment or anti-tumor medication. 2.Subjects with gastrointestinal disorders such as inflammatory bowel syndrome, irritable bowel syndrome, etc. 3.Subjects under iron reduction therapy. 4.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 5.Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 6.Subjects with unusually high and/or low blood pressure, abnormal physical data and/or abnormal hematological data. 7.Subjects with severe anemia. 8.Pre- or post-menopausal women complaining of obvious physical changes. 9.Subjects who are at risk of having allergic reactions to drugs and/or foods especially koji. 10.Subjects who regularly take medicine, functional foods, and/or supplements which would affect bowel movements or intestinal environment. 11.Subjects who regularly take functional foods and/or supplements containg iron. 12.Subjects who regularly take koji and/or amazake 100 g/day. 13.Heavy smokers, alcohol addicts and/or subjects with disordered lifestyle. 14.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 current study. 15.Pregnant or lactating women or women who expect to be pregnant during this study. 16.Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 17.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
- Secondary Outcome Measures
Name Time Method