A Study on the Effect of Food Containing Plant Extract on Mood -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
- Conditions
- o
- Registration Number
- JPRN-UMIN000051050
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 70
Not provided
Subjects (who) 1)have a probability of idiopathic chronic fatigue or chronic fatigue syndrome based on self-report. 2)have a chronic disease and regularly use medications. 3)have a probability of depression by CES-D scores, medical interview, etc. 4)with a history of and/or current sleep disorders. 5)contract or are under treatment for serious diseases (eg, liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal disease and/or metabolic disease). 6)use supplements, functional foods, or drugs associated with fatigue recovery or lack of sleep. 7)have a history and/or a surgical history of digestive disease affecting digestion and absorption. 8)may have allergy to test foods. 9)are pregnant or planning to become pregnant or breastfeed during the study period. 10)have excessive alcohol intake more than 20 g/day of pure alcohol equivalent for more than 4 days a week. 11)can't stop drinking from 2 days before each measurement. 12)are under treatment for or have a history of drug addiction and/or alcoholism. 13)smoke 20 or more cigarettes a day, or cannot quit smoking during from waking to inspection completed. 14)are shiftworker, midnight worker and/or physical labor. 15)have regular hard exercise. 16)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. 17)are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. 18)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
- Secondary Outcome Measures
Name Time Method