A Study on the Effect of Food Containing Plant Extract on Postprandial Blood Glucose -A Randomized, Double-blind, Placebo-controlled, Cross-over Study
- Conditions
- o
- Registration Number
- JPRN-UMIN000035710
- Lead Sponsor
- KSO Corporation
- Brief Summary
Statistically significant difference was confirmed in the primary outcome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
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. (2) Subjects who use medications affecting blood glucose level. (3) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting blood glucose level during test periods. (4) Subjects who have declared allergic reaction to ingredients contained in test foods or loading foods. (5) Subjects who are diagnosed as diabetes by the screening tests I or II. (6) Subjects who contract, are under treatment for or have a history of serious diseases (e.g., kidney and liver disease, and heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder. (7) Subjects who have a chronic disease and regularly use medications. (8) Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption. (9) Subjects who are judged unsuitable for the current study by the screening tests. (10) Subjects who are diagnosed as anemic by the screening tests and unsuitable for frequent blood sampling. (11) Subjects who have had diarrhea within the last one week prior to the screening tests. (12) Subjects who have donated over 200 mL of blood and/or blood components within the last one month or over 400 mL of blood and/or blood components within the last three months prior to the current study. (13) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. (14) Subjects who are planning to participate in other clinical studies during test periods and/or had participated in other clinical studies within the last one month prior to the current study. (15) Subjects who are planning to become pregnant after informed consent, pregnant or lactating. (16) Subjects who are judged unsuitable for the current study by the investigator for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method