Safety of Overconsumption of a Food Containing of Plant Extract
- Conditions
- /A(healthy adults)
- Registration Number
- JPRN-UMIN000028316
- Lead Sponsor
- TES Holdings Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 36
Not provided
[1]Individuals using medical products. [2]Individuals who are patient or have a history of psychiatric disease, 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 who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [7]Individuals who experienced unpleasant feeling during blood drawing. [8]Individuals who are sensitive to a test product or other foods, and medical products. [9]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). [10]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [11]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [12]Individuals who are or are possibly, or are lactating. [13]Individuals who participated in other clinical studies in the past 3 months. [14]Individuals who are or whose family is engaged in healthy or functional foods. [15]Individuals judged inappropriate for the study by the principal.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method [1]Existence and its contents of side effects: expression number and expression rate of side effects (expression rate: number of cases/number of cases analyzed) (SCR, Week 0, Week 2, Week 4)
- Secondary Outcome Measures
Name Time Method *Secondary outcomes [1]Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed) (SCR, Week 0, Week 2, Week 4) [2]Blood pressure, pulsation (SCR, Week 0, Week 2, Week 4) [3]Weight, body fat percentage, BMI (SCR, Week 0, Week 2, Week 4) [4]Hematologic test (SCR, Week 0, Week 2, Week 4) [5]Blood biochemical test (SCR, Week 0, Week 2, Week 4) [6]Urine analysis (SCR, Week 0, Week 2, Week 4) [7]Doctor's questions (SCR, Week 0, Week 2, Week 4) *Other index [1]Subject's diary (each day during the test period)