Effect of the test food on sleep and fatigue - A randomized, double blinded, parallel group comparison study
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000037840
- Lead Sponsor
- TTC Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 90
Not provided
1.Subject who is under medication treatment, dietetic therapy, or exercise therapy 2.Subject who is under sleep, stress, and/or fatigue treatment 3.Subject who has or has a history of diabetes, liver disease, kidney disease, heart disease, having troubles in adrenocortical hormone secretion, or other metabolic disease 4.Subject who has history of mental illness, chronic fatigue syndrome or sleep disturbance 5.Subject who has been diagnosed as or who is suspected as sleep apnea syndrome 6.Subject who is taking regular medication, or who has or had a history of serious disease that requires regular medication 7.Subject who is regularly taking medication, quasi-medicine, health food or food with functional claims that affect the test results 8.Subject who is a day shift worker or is involved in manual labor such as heavy object transportation 9.Subject whose working days and non-working days are irregular 10.Subject who is planning to work on more than 2 night shifts during the study period 11.Subject who showed abnormal clinical test results or cardiopulmonary function and has been decided as an inappropriate candidate for the present study 12.Subject who has an allergy for the test food 13.Subject who is currently pregnant or planning to get pregnant and breast feed the baby during the study period 14.Subject who has participated in other clinical studies within the last one months 15.Subject who cannot follow the regulations of the current study and cannot carry out the specified questionnaires 16.Subject who is decided as an inappropriate candidate according to the life style habit questionnaire 17.Subject who showed abnormal physical examination value and other clinical test values 18.Subject who is planning to go abroad during the study period, or is planning to go for a domestic travel for more than 7 consecutive days 19.Subject who is considered as an inappropriate candidate by the doctor in charge or the lead principal investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method