A Study on the Effect of Food Containing Plant Extract on QOL -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
- Conditions
- o
- Registration Number
- JPRN-UMIN000044186
- Lead Sponsor
- KSO Corporation
- Brief Summary
Statistically significant difference was confirmed in the primary outcome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
Subjects (who) 1)are judged by doctors to have a high probability of chronic fatigue syndrome. 2)contract or are under treatment for serious diseases (e.g., liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, and/or other metabolic disease). 3)have a chronic disease and use medications. 4)contract or have a surgical history of digestive disease affecting digestion and absorption. 5)may have allergy to test foods. 6)have alcohol intake more than approximately 20 g/day of pure alcohol equivalent or a habit of drinking not less than 4 days a week. 7)can't stop drinking from 2 days before each measurement. 8) smoke 10 or more cigarettes a day, or cannot quit smoking during from waking to inspection completed. 9)use drugs, supplements, or functional foods associated with fatigue recovery. 10)are shiftworker, midnight worker and/or hard worker. 11)have regular hard exercise. 12) are pregnant or breast-feeding or planned to become pregnant during the study period. 13) have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study. 14)are participating in or willing to participate in other clinical studies. 15)are judged as unsuitable for the current study by the investigator for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method QOL questionnaire
- Secondary Outcome Measures
Name Time Method complexion