A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level. -Randomised double-blind placebo-controlled trial
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000035336
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
(1) Individuals whose fasting blood glucose level at the time of screening is 126mg/dl or more, or glucose level is 200mg/dl or more 2 hours after the glucose load test (2)Individuals who use oral medication affecting blood glucose level (3)Individuals who constantly use supplements and/or functional foods, including food for specified health use and/or food with function claims, affecting blood glucose level (4)Individuals who were judged to be diagnosed with diabetes at the screening checkup (5)Individuals who are suffering from or under treatment of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder (6) Individuals who have a chronic disease and use medicines continuously (7)Individuals who have a history of digestive disease and/or surgical history affecting digestion and absorption , have a disorder such as stenosis in the gastrointestinal tract (8)Individuals who had an onset diarrhea within one week from the date of screening, and who is prone to diarrhea always (9)Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period (10) Individuals 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 Time course of blood glucose level and AUC (area under the curve)(0-2hrs).
- Secondary Outcome Measures
Name Time Method Time course of blood insulin level and AUC (area under the curve)(0-2hrs).