A clinical study to evaluate the effects of the test food on attenuating fatigue sensatio
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-UMIN000041228
- Lead Sponsor
- Soiken Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 24
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 who take regularly pharmaceuticals or quasi-drugs which having the efficacy for recovery from fatigue or nutritional supplements during physical fatigue 4) Subjects who take regularly Foods with Function Claims labeled the effect of attenuating fatigue sensation 5) Subjects who have the possibility of developing allergic symptoms by the test food 6) Female subjects who are pregnant or lactating, or intending to become pregnant during the study 7) 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) 8) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 9) Subjects deemed unsuitable by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VAS(fatigue sensation)
- Secondary Outcome Measures
Name Time Method VAS(eyestrain, sleepiness, shoulder stiffness, dullness or heaviness in the body, motivation), Jikaku-sho shirabe, Pittsburgh Sleep Quality Index, OSA sleep inventory MA version, Karolinska Sleepiness Scale, POMS2 Japanese version, work performance evaluation, cognitive function test, autonomic nervous function evaluation, urinalysis