Healthy volunteers
Conditions
Interventions
Intake of test food for 4 weeks - >
Intake of placebo for 4 weeks
Intake of placebo for 4 weeks - >
Sponsors
Soiken Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females whose age of 20 years or more and less than 65 years 2) Subjects who perceive fatigue sensation in daily work 3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS(fatigue sensation) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTomohiro Sugino
Soiken Inc. R&D Division
Outcome results
None listed