A study to evaluate the effects of the test food on improving fatigue sensation, cognitive function and sleep quality
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-UMIN000052464
- Lead Sponsor
- Japan Preventive Medicine Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 48
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 drinking a lot (Subjects whose pure alcohol intake per day is 60 g or more) 3) Subjects having the possibility of developing allergic symptoms by the test food 4) Subjects whose lifestyles are irregular because of night shift or others 5) Subjects waking up for urination 2 times or more during nocturnal sleep 6) Subjects living with their infants less than 1 year old 7) Subjects sleeping with others in a bedroom 8) Subjects taking regularly medicines and quasi-drugs having the effects on fatigue sensation, cognitive function and sleep quality 9) Subjects taking regularly Food with Functional Claims having the effects on fatigue sensation, cognitive function and sleep quality 10) 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) 11)Subjects who are pregnant or lactating, or intending to become pregnant during the study 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) Subjects deemed unsuitable by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VAS (fatigue sensation)
- Secondary Outcome Measures
Name Time Method VAS (sleepiness, motivation, concentration), Chalder fatigue scale, POMS2 Japanese version, autonomic nervous function, blood analysis (adrenalin, noradrenalin, dopamine, d-ROMs, BAP), saliva analysis (HHV-6, HHV-7), cognitive function test, OSA sleep inventory MA version, The St. Mary's Hospital sleep questionnaire, objective sleep evaluation