A study to evaluate the safety of excessive intake of test food in a healthy adult subject
- Conditions
- /A
- Registration Number
- JPRN-UMIN000038180
- Lead Sponsor
- Research & Development Institute, House Wellness Foods Corporation
- 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 receive a drug treatment (2) Subjects who have a history of serious disorder (heart disease, liver disease, kidney, digestive system disease, or et al.) (3) Females who have diagnosed pregnancy or is breast-feeding (4) Subjects who have medication or food allergy (5) Subjects who have excessive alcohol-drinking (6) Subjects who have extremely irregular dietary habits (7) Subjects who are participating in other trial, have participated in the past 4 weeks, or plan to participate in other trial during scheduled period in this trial (8) Subjects who have made a blood donation of 200 mL within the last one month prior to this study (9) Male subjects who have made a blood donation of 400 mL within the last three months prior to this study (10) Female subjects who have made a blood donation of 400 mL within the last four months prior to this study (11) Male subjects who have made a blood donation over an amount (1,200 mL minus the estimated volume of blood sampling during the study) within the last one year prior to this study (12) Female subjects who have made a blood donation over an amount (800 mL minus the estimated volume of blood sampling during the study) within the last one year prior to this study (13) Subjects judged as unsuitable for the study by the investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse events and side effects
- Secondary Outcome Measures
Name Time Method (1) Physical measurement (Body weight, Body mass index, body fat percentage) (2) Physical examination (3) Blood biochemical test (4) Hematological test (5) Urinalysis