Safety evaluation of an excessive consumption of test food: a randomized, double-blind, placebo-controlled trial
- Conditions
- Hyperglycemia
- Registration Number
- JPRN-UMIN000045063
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1. Subjects with milk allergy or lactose intolerance 2. Subjects who were diagnosed with diabetes by the screening test 3. Sever systemic diseases affecting the results of this study 4. Subjects who have chronic illness and who take medication everyday 5. Subjects who were judged unsuitable as subjects by clinical examination at the screening test 6. Subjects who donated blood of more than 200 mL within a month or more than 400 mL within 3 months 7. Subjects who drink a lot of alcohol 8. Subjects who have been drug dependency 9. Subjects who participated in other clinical trials within one month before the agreement of participants in this study 10. Subjects in pregnancy or in nursing 11. Subjects who are judged as unsuitable for the study by the investigator for other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hematologic test, blood biochemistry test, urine analysis, blood pressure/pulsation, weight/body mass index, doctor's questions, and adverse event (Evaluate at points of 2 week and 4 week of ingestion and 2 weeks after the end of ingestion period)
- Secondary Outcome Measures
Name Time Method