Healthy volunteers
Conditions
Sponsors
Soiken Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy males and females aged 20- 65 years 2) Subjects who perceive fatigue sensation in daily life 3) Subject whose BMI is 23.0 kg/m2 or more and less than 30.0 kg/m2 4) 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 receiving a medical treatment for sleep disorders 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 take pharmaceuticals or quasi-drugs which having the efficacy for improving sleep quality 7) Subjects who take Foods with Function Claims labeled the effect of improving sleep quality 8) Subjects whose lifestyles are irregular because of night shift or others 9) Subjects who have the possibility of developing allergic symptoms by the test food 10) Female subjects who are pregnant or lactating, or intending to become pregnant during the study 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 study within 3 months prior to the start of the present study or who is currently taking part in another study 13) Subjects deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS(fatigue sensation) | — |
Secondary
| Measure | Time frame |
|---|---|
| Chalder fatigue scale, POMS2 Japanese Adult Short version, OSA sleep inventory MA version, St. Mary's Hospital sleep questionnaire, autonomic nervous function evaluation, blood test, immunity evaluation, questionnaire on defecation, body weight, waist circumference, BMI | — |
Countries
Japan
Contacts
Public ContactKota Watanabe
Soiken Inc. R&D Division
Outcome results
None listed