Safety confirmation test by continuous intake of test food on Healthy Adult Males and Females.
- Conditions
- o
- Registration Number
- JPRN-UMIN000052719
- Lead Sponsor
- TES Holdings Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 40
Not provided
1) Individuals using medical products. 2) Individuals who are patient or have a history of psychiatric disease, sleep disorder, high blood pressure, diabetes and hyperlipidemia. 3) Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). 4) Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. 5) Individuals who are a patient or have a history of or endocrine disease. 6) Individuals whose BMI is less than 18.5kg/m2 and over 30kg/m2. 7) Individuals whose systolic and diastolic blood pressures are over 140mmHg and 90mmHg, respectively and pulse rate of 85 beats/min or higher. 8) Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. 9) Individuals who experienced unpleasant feeling during blood drawing. 10) Individuals with drug (including alcohols) and food allergies. 11) Individuals who habitually take the foods for specified health uses (FOSHU) or functional food (except for subjects who can stop consume them after informed consent). 12) Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30g/day). 13) Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. 14) Individuals who are pregnant, lactating, or who may become pregnant during the test period. 15) Individuals who participated in other clinical studies in the past 3 months. 16) Individuals who are or whose family is engaged in functional foods or cosmetics. 17) Individuals judged inappropriate for the study by the principal.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method