Effect of Daily Ingestion of Test Food on Stress Relief: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
- Conditions
- Healthy Adult
- Registration Number
- JPRN-UMIN000047467
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
1.Subjects with a clinical history of gastrointestinal cancer or currently under treatment or anti-tumor medication. 2.Subjects with gastrointestinal disorders. 3.Subjects who may cause some skin troubles by measuring heart rate variability. 4.Subjects who take digoxin. 5.Subjects who have used antibiotics within 12 wks prior to this study. 6.Subjects who are under physician's advice, treatment, and/or medication for schizophrenia, depression, mania, neurological disorders, and/or sleep disorders. 7.Subjects with ACP. 8.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 9.Subjects with major surgical history relevant to the digestive system. 10.Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 11.Subjects with severe anemia. 12.Pre- or post-menopausal women complaining of obvious physical changes. 13.Subjects who are at risk of having allergic reactions to drugs or foods especially based on wheat, milk, and egg. 14.Subjects who regularly take drugs and/or functional foods which affect bowel movements, gut microbiota, stress and/or sleep. 15.Subjects who regularly take staple food with high dietary fiber. 16.Subjects who regularly take yoghurt, lactic acid bacteria beverage, and/or natto. 17.Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 18.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 this study. 19.Pregnant or lactating women or women who expect to be pregnant during this study. 20.Subjects who currently participate in other clinical trials, or participated within the last 4 wks prior to this study. 21.Any other medical and/or health reasons unfavorable to participation in this study, as judged by the principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VAS questionnaire on stress at 4 weeks after beginning the intake of test food.
- Secondary Outcome Measures
Name Time Method Bowel diary, gut microbiota, fatty acids in feces, IgA in feces, BDNF in blood, cortisol in saliva, heart rate variability, sleeping record, survey on subjects' sleeping and mental and physical conditions, VAS questionnaire.