A randomized, double-blind, placebo-controlled, crossover study on the suppressive effect of the peptide on postprandial blood glucose level
- Conditions
- ot applicable
- Registration Number
- JPRN-UMIN000048002
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1) Subjects who are undergoing continuous medical treatment. 2) Subjects who regularly restrict carbohydrates. 3) Subjects who regularly take Foods for Specified Health Uses, Foods with Function Claims, health foods, etc., which may affect the study, and who cannot stop taking them during the study period. 4) Subjects who smoke 20 cigarettes or more per day. 5) Subjects with BMI of 30.0 kg/m2 or more. 6) Subjects who have difficulty in blood collection. 7) Subjects who excessively take alcohol. 8) Subjects who have a previous or current medical history of serious diseases in heart, liver, kidney, digestive organs, etc. 9) Subjects who are pregnant, planning to become pregnant, or lactating. 10) Subjects who have serious allergies to medicines and foods (especially eggs, wheat, and dairy products). 11) Subjects who are currently participating in another clinical trial of a drug or food, or participated in that trial within 4 weeks, or planning to participate in that trial after giving informed consent to participate in this trial. 12) Subjects who have donated over 200 mL of blood within 1 month and over 400 mL within 3 months before beginning this study. 13) Subjects who are judged as ineligible to participate in this study by the principal investigator or sub-investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area under the curve of blood glucose levels (0-120 min)
- Secondary Outcome Measures
Name Time Method Postprandial blood glucose levels (each time point), Cmax of blood glucose level, Tmax of blood glucose level, insulin levels (each time point), insulinogenic index