A study for safety evaluation of excess consumption of the test food.
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000028377
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
(1)Subjects who constantly use oral medicines, food for specific health use, functional display foods and/or supplements having a possibility of affecting test results. (2) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. (3) Subjects who have previous and/or current medical history of serious disease in heart, liver, kidney, digestive organ. (4) Subjects who excessive alcohol intake. (5) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work. (6) Subjects who have previous medical history of drug and/or food allergy. (7) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. (8) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. (9) Subjects who donated over 400mL blood and/or blood components within the last three month to the current study. (10) Females who donated over 400mL blood and/or blood components within the last four month to the current study. (11) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (12) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (13)Subjects who have weak digestive organ. Especially subjects who feel discomfort for example stomach astigmatism after intake of drinks containing tannin like strong green tea, black tea and coffee. (14) Others who have been determined ineligible by principal investigator or sub-investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Presence or absence of, type of, severity of and frequency of side effects and adverse events (include clinical test data).
- Secondary Outcome Measures
Name Time Method The inspection items at 2 and 4 weeks after beginning of ingestion of the test food, and at 2 weeks after end of ingestion of the test food as follows. Medical interview, body length, body weight, body fat percentage, BMI, systolic blood pressure, diastolic blood pressure, heart rate, blood biochemical test (TP, ALB, AST, ALT, LDH, T-BIL, ALP, ganma-GTP, CPK, BUN, CRE, UA, Na, Cl, K, Ca, T-Cho, LDL-Cho, HDL-Cho, TG, GLC, HbA1c) , hematological test (WBC, RBC, Hb, Ht, and PLT), and urine analysis (protein, sugar, urobilinogen, bilirubin)