Healthy volunteers
Conditions
Interventions
Intake of the test food for 4 weeks
Intake of the placebo for 4 weeks
Sponsors
Soiken Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy males and females whose age of 20 years or more and less than 65 years 2) Subjects who are aware of fatigue sensation in daily life 3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntary participate in the study and being able to personally sign a written informed consent
Exclusion criteria
Exclusion criteria: 1) Subjects receiving a medical treatment for serious renal, hepatic, cardio-vascular, 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 have mental disease such as depression and schizophrenia 5) Subjects who have sleep disorders to need medical treatment 6) Subjects who have the possibility of developing allergic symptoms by the test food 7) Subjects who take regularly pharmaceuticals or quasi-drugs which having the efficacy for recovery from fatigue or nutrient replenishment in case of physical fatigue 8) Subjects who take regularly Foods with Function Claims labeled the effect of attenuating fatigue sensation 9) Subjects who drink a lot (Subjects whose pure alcohol intake per day is 60 g or more) 10) BMI<17 kg/m2 and >=30 kg/m2 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 clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 13) Female subjects who are pregnant or lactating, or intending to become pregnant during the study 14) Subjects deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS(integral fatigue sensation, physical fatigue sensation and mental fatigue sensation) | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS(sleepiness, motivation and concentration), autonomic nervous function evaluation, work performance evaluation, blood analysis and urinalysis | — |
Countries
Japan
Contacts
Public ContactShinichi Kashiwagi
Soiken Inc. R&D Division
Outcome results
None listed