A study to evaluate the effects of the test food on improving fatigue sensation, sleep quality and cognitive functio
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-UMIN000048599
- Lead Sponsor
- Japan Preventive Medicine Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 24
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 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 medicines and quasi-drugs having the effects on fatigue sensation, sleep quality and cognitive function 4)Subjects who take regularly Food with Functional Claims having the effects on fatigue sensation, sleep quality and cognitive function 5)Subjects whose lifestyles are irregular because of night shift or others 6)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) 7)Subjects who have the possibility of developing allergic symptoms by the test food 8)Subjects who are pregnant or lactating, or intending to become pregnant during the study 9)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 10)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 (eyestrain, sleepiness, motivation, concentration), Jikaku-sho shirabe, OSA sleep inventory MA version, The St. Mary's Hospital sleep questionnaire, Karolinska Sleepiness Scale Japanese version, POMS2 Japanese version, work performance, cognitive function test, autonomic nervous function, vascular state, sleep and activity tracker, urinalysis, blood analysis