Safety of Overconsumption of a Test Food
- Conditions
- /A(healthy adults)
- Registration Number
- JPRN-UMIN000031206
- 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
- 24
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 whose fasting blood glucose is over 126mg/dL or HbA1c (NGSP) is over 6.5%. [7]Individuals whose systolic and diastolic blood pressures are over 140mmHg and 90mmHg, respectively. [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 who are sensitive to a test product or other foods, and medical products. [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 have a habit to intake a product similar with a test food. [13]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [14]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [15]Individuals who are or are possibly, or are lactating. [16]Individuals who participated in other clinical studies in the past 3 months. [17]Individuals who cannot refrain from eating between meals. [18]Individuals who are or whose family is engaged in functional foods or cosmetics. [19]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) (Week 2, Week 4, 2 weeks after the end of ingestion of a test food) .
- 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) (Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food) . [2]Blood pressure, pulsation (Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food) . [3]Weight, body fat percentage, BMI (Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food) . [4]Hematologic test (Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food) . [5]Blood biochemical test (Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food) . [6]Urine analysis (Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food) . [7]Doctor's questions (Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food) . *Other index [1]Subject's diary (each day during the test period).