A study for evaluating the effects of oral intake of food originated from a microorganism on fatigue and immune functions. A randomized, double-blind, placebo- controlled trial.
- Conditions
- Healthy subjects
- Registration Number
- JPRN-UMIN000028717
- Lead Sponsor
- Department of Sports Medicine (internal medicine), Juntendo University School of Health and Sports Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
1)Individuals who have a medical history of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder. 2)Individuals who have chronic diseases and use medicines continuously. 3)Individuals who need the application of medicine containing steroids. 4)Individuals who are seropositive against HBV antigen, HCV antibody, HIV antibody, or HTLV-1 antibody. 5)Individuals who cannot stop eating foods containing ingredients similar to test foods. 6)Individuals who cannot stop eating functional foods which may affect immune functions. 7)Individuals with excessive alcohol-drinking behaviors. 8)Individuals who cannot stop drinking for 2 days before the days of checkup. 9)Individuals who have a medical history of diseases affecting digestion and absorption. 10)Individuals who have a history of inflammatory bowel disease and irritable bowel syndrome. 11)Individuals who are judged as unsuitable for this study based on the results of blood test. 12)Individuals who have under treatment or a history of drug addiction and/or alcoholism. 13)Individuals who are participating or willing to participate in other clinical trials. 14)Individuals whose family works for a company manufacturing or selling healthy foods or functional foods. 15)Individuals who cannot sleep at night due to the irregular work-shift or other reasons. 16)Individuals who are judged unsuitable for this study by the investigator for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fatigue and stress indices (subjective indices)
- Secondary Outcome Measures
Name Time Method Fatigue and stress indices (objective indices), immune indices (subjective indices)