Clinical Study to Investigate the Effect of the Functional Food on Improving Minor Health Complaints: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000048849
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 90
Not provided
1.Subjects who are under physician's advice, treatment, and/or medication for schizophrenia, depression, mania, neurological disorders, sleep disorders, and/or chronic fatigue syndrome. 2.Subjects who receive nourishment instruction. 3.Subjects with implantable electronic medical devices. 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 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 or foods especially based on wheat, soybean, egg, milk, cocoa. 10.Subjects who regularly take medicine, functional foods, and/or supplements which would affect sleep and/or stress. 11.Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 12.Subjects who donated either 400 ml whole blood within 16 wks (women), 12 wks (men), 200 ml whole blood within 4 wks, or blood components within 2 wks, prior to the current study. 13.Pregnant or lactating women or women who expect to be pregnant during this study. 14.Subjects who currently participate in other clinical trials, or participated within the last 4 wks prior to the current study. 15.Subjects whose lifestyle is expected to change significantly. 16.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 The Brief Job Stress Questionnaire (Section B) after 4 weeks of ingestion.
- Secondary Outcome Measures
Name Time Method Survey on subjects' sleeping, bowel movement, mental and physical condition, sense of accomplishment.