Safety evaluation study of overdose of test food in healthy adults
- Conditions
- Healthy Adults
- Registration Number
- JPRN-UMIN000050091
- Lead Sponsor
- Healthcare Systems Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Not provided
1.Persons who have chronic illness, receiving medication, have a serious disease history 2.Persons who are allergic to the test food 3.Persons who regularly take a large amount of the test food 4.Persons who regularly use medicines or foods with health claims (foods for specified health use, foods with functional claims and foods with nutritional claims) etc., that may affect blood test values, urine test values, and blood pressure 5.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam 6.Persons who were judged as inappropriate for study participants by the principal investigator 7.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse event rate
- Secondary Outcome Measures
Name Time Method Blood test (white blood cell count, red blood cell count, hemoglobin, hematocrit, platelet count, total protein, albumin, triglyceride, total cholesterol, HDL-cholesterol, LDL-cholesterol, AST (GOT), ALT (GPT), ALP, gamma -GTP, CPK, total bilirubin, uric acid, urea nitrogen, creatinine, sodium, potassium, chloride, calcium, phosphorus, magnesium, LDH, glucose) Urinalysis (urine protein qualitative, urinary glucose qualitative, urinary PH, urinary occult blood test) Physical examination (height, weight, BMI, blood pressure)