Healthy volunteers
Conditions
Interventions
Intake of test food for 2 weeks - >
Washout for 2 weeks ->
Intake of placebo for 2 weeks
Intake of placebo for 2weeks - >
Sponsors
Soiken Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females whose age of 45 years or more and less than 65 years 2) Subjects who perceive 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 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) Outpatients with chronic diseases 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 have the possibility of developing allergic symptoms by the test food 7) 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 8) Female subjects who are pregnant or lactating, or intending to become pregnant during the study 9) Subjects deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS(fatigue sensation) | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS(feeling of stress, cold sensitivity of hands and feet, vitality) | — |
Countries
Japan
Contacts
Public ContactTomohiro Sugino
Soiken Inc. R&D Division
Outcome results
None listed