A clinical study to evaluate the anti-fatigue effects of food material
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-UMIN000038259
- Lead Sponsor
- Soiken Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 20
Not provided
1)Subjects receiving a medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 2)Subjects having the chronic fatigue syndrome(CFS), or subjects deemed to have severe fatigue like idiopathic chronic fatigue by the investigator 3)Subjects who go to a doctor about chronic diseases 4)Subjects who take regularly pharmaceuticals or quasi-drugs which having the efficacy for recovery from fatigue or nutrient replenishment in case of physical fatigue 5)Subjects who take regularly Foods with Function Claims labeled the effect of attenuating fatigue sensation 6)Subjects who have the possibility of developing allergic symptoms by the test food 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)Female subjects who are pregnant or lactating, or intending to become pregnant during the study 10)Subjects deemed unsuitable by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VAS(integral fatigue sensation, physical fatigue sensation and mental fatigue sensation)
- Secondary Outcome Measures
Name Time Method VAS(perceived stress, tension, sleepiness, boredom, motivation, hunger sensation, thirstiness, jitteriness, refreshing feeling), POMS2 Japanese version, autonomic nervous function evaluation, work performance evaluation, blood analysis, urinalysis and stool analysis