A study to confirm the safety of overdose of test food: a randomized, double-blind, placebo-controlled trial.
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000049913
- Lead Sponsor
- KSO Corporation
- Brief Summary
Safety was confirmed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1. Subjects who have a history of Serious diseases such as diabetes, kidney/liver disease or heart disease, and/or thyroid diseases, adrenal diseases, and other metabolic diseases or who is under medical treatment. 2. Subjects who have chronic disease and is under medication. 3. Subjects who have a history of gastrointestinal disease or gastrointestinal surgery that affects digestion and absorption. 4. Subjects who have a history of drug dependence or alcohol dependence or have a current medical history. 5. Those who consistently drink more than the recommended amount of alcohol. 6. Subjects who cannot abstain from drinking 2 days before each test. 7. Subjects who has food allergy. 8. Subjects who are judged to be inappropriate as research subjects by blood tests in screening tests. 9. Subjects who has collected or donated more than 200 mL of blood or blood components within 1 month or more than 400 mL of blood or blood within 3 months prior to the date of obtaining consent. 10. Subjects who are participating in other studies that using foods, pharmaceuticals, and cosmetics now, or are willing to participate. 11. Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period. 12. Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method