A study to evaluate the effects of plant extract material on fatigue sensation and sleep
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-UMIN000045634
- Lead Sponsor
- Soiken Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 120
Not provided
1) Subjects with serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 2) Subjects with chronic fatigue syndrome (CFS) , or subjects deemed to have severe fatigue such as idiopathic chronic fatigue by the investigator 3) Subjects receiving a medical treatment for sleep disorders 4) Subjects who take regularly pharmaceuticals or quasi-drugs which having the efficacy for recovery from fatigue or nutritional supplements during physical fatigue 5) Subjects who take regularly Foods with Function Claims labeled the effect of attenuating fatigue sensation 6) Subjects who take pharmaceuticals or quasi-drugs which having the efficacy for improving sleep quality 7) Subjects who take Foods with Function Claims labeled the effect of improving sleep quality 8) Subjects whose lifestyles are irregular because of night shift or others 9) Subjects who have the possibility of developing allergic symptoms by the test food 10) Female subjects who are pregnant or lactating, or intending to become pregnant during the study 11) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood) 12) Subjects who took part in another study within 3 months prior to the start of the present study or who is currently taking part in another study 13) Subjects deemed unsuitable by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method