A study for safety evaluation of excess consumption of the test food.
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000032335
- Lead Sponsor
- CPCC Co., Ltd.
- Brief Summary
It was judged that there was no problem in safety.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
(1) Subjects who have lactose intolerance. (2) Subjects who can't refrain restricted and/or prohibited foods during the test. (3) Subjects who take medications that affect intestinal environment, digestion and absorption at the time of advance inspection. (4) Subjects who regularly use laxatives, intestinal regulator, etc. (5) Pregnant or possibly pregnant, or lactating women. (6) Subjects who have a history of and/or current medical history of severe diseases such as heart, liver, kidney, digestive organs, drug dependence, alcohol dependence. (7) Subjects who excessive alcohol intake. (8) Subjects who have extremely irregular life rhythms, and have midnight work or irregular shift work. (9) Subjects who have previous medical history of drug and/or food allergy. (10) Subjects who have chronic illness and regularly use medicines. (11) Subjects who were judged unsuitable for the clinical test from the results of the blood test at advance inspection. (12) Subjects who are participating the other clinical tests and participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. (13) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. (14) Males who donated over 400mL blood and/or blood components within the last three months to the current study. (15) Females who donated over 400mL blood and/or blood components within the last four months to the current study. (16) 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. (17) 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. (18) 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 (1) Presence or absence of, type of, severity of and frequency of side effects and adverse events (include clinical test data). (2) Presence or absence of abnormal variations in clinical test data.
- Secondary Outcome Measures
Name Time Method