A study to evaluate the effects of food material on attenuating fatigue sensatio
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-UMIN000045452
- Lead Sponsor
- Soiken Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 120
Not provided
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 or maintaining immune function 6) Subjects who take regularly health food rich in citric acid 7) Subjects who have the possibility of developing allergic symptoms by the test food 8) 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) 9) 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 10) Female subjects who are pregnant or lactating, or intending to become pregnant during the study 11) Subjects with mental disorders such as depression, with sleep disorders requiring treatment 12) Subjects who have the plan to receive a vaccine such as the influenza vaccine or the COVID-19 vaccine from 2 weeks before to 4 weeks after the start of test food intake 13) Subjects who have the habit to do regularly vigorous exercise (e.g. marathon running) or have the plan to do so during the study 14) Subjects who have the plan to change their lifestyle (sleeping time, eating habits, etc.) significantly during the study 15) 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(perceived stress, sleepiness, thirstiness, jitteriness), POMS2 Japanese version, blood test(natural killer cell activity, plasmacytoid dendritic cell activity, macrophage activity), saliva test(secretory immunoglobulin A), questionnaire on physical condition