A study to evaluate the effects of research food on attenuating fatigue sensation -A randomized, double-blind, placebo-controlled, parallel-group study
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-UMIN000052281
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 120
Not provided
1)Subject who take supplements, health foods, or medicine related to recovery from fatigue or lack of sleep. 2)Subjects with current or past history of serious illness. 3)Subjects who take medicines due to chronic diseases. 4)Subjects who have been diagnosed with chronic fatigue syndrome. 5)Subjects who are considered as a depression based on the screening tests. 6)Subjects who have digestive disease or a history of digestive surgery 7)Subject with BMI >30kg/m2 8)Subjects who have allergy to the research food 9)Subjects who take supplements (EPA/DHA, GABA, citric acid, imidazole dipeptide astaxanthin, coenzyme Q10, etc.) that may affect the research results. 10)Subjects who take general beverages that may affect fatigue, such as Red Bull, Oronamin C, Monster, etc. 11)Subjects who have the habit to do regularly vigorous exercise 12)Subjects who have a habit of drinking more than 20 g/day of pure alcohol, 5 days or more a week. 13)Subjects who are unable to stop drinking from 2 days before screening test and each test. 14)Shift worker or midnight shift worker 15)Subjects who have plans to travel abroad, move, etc. during the research period and have major lifestyle changes. 16)Subjects who are considered as an inappropriate candidate based on the screening tests by the principal doctor or co-research doctor. 17)Subjects who are pregnant, lactating, or planning to get pregnant 18)Subjects who donated blood of over 200 mL in the past 1 month or over 400 mL in the past 3 months 19)Subjects who are planning to participate another clinical study during the study period 20)Subjects who are considered as an inappropriate candidate for other reasons by the principal doctor or co-research doctor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VAS(fatigue sensation)
- Secondary Outcome Measures
Name Time Method POMS2 (All Items Version)