A Study on the Effect of Plant Extract on Postprandial Blood Glucose and Serum Triglyceride -A Randomized, Double-blind, Placebo-controlled, Cross-over Study
- Conditions
- o (include borderline diabetes)
- Registration Number
- JPRN-UMIN000038956
- Lead Sponsor
- TOYO SHINYAKU Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
(1) Subjects whose fasting blood glucose level is 126 mg/dL and over or two-hour blood glucose level after 75 g glucose loading is 200 mg/dL and over and/or who have been diagnosed with diabetes. (2) Subjects whose fasting serum triglyceride level is 45 mg/dL or less and 150 mg/dL or over, or casual serum triglyceride level is 650 mg/dL and over. (3) Subjects who contract or are under treatment for serious diseases (e.g., diabetes, liver disease, kidney disease, digestive system disease, heart disease, respiratory disease, peripheral vascular disorder, etc.). (4) Subjects who use oral medication affecting blood glucose or lipid metabolism. (5) Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses, Foods with Functional Claims) affecting blood glucose or lipid metabolism. (6) Subjects with abnormal parameters in liver and/or kidney function. (7) Subjects who have a history of digestive disease surgery. (8) Subjects with a disease that may have an influence on this study currently under treatment. (9) Subjects who have declared an allergic reaction to test foods, or loading foods. (10) Subjects with anemia or who have difficulty with self blood collection. (11) Subjects who play high intensity sports and/or are on a diet. (12) Subjects with irregular life patterns. (13) Subjects who use medicines (including OTC and/or prescribed medications) continuously. (14) Subjects who drink excessive alcohol, or who can't stop drinking from one day before each measurement. (15) Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating. (16) Subjects who are planning to participate in other clinical studies. (17) 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 Blood glucose AUC and Serum triglyceride AUC
- Secondary Outcome Measures
Name Time Method