A Study on the Effect of Food Containing Polydextrose on Postprandial Blood Glucose -A Randomized, Double-blind,Placebo-controlled, Cross-over Study
- Conditions
- o(Borderline diabetes)
- Registration Number
- JPRN-UMIN000022121
- 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 who use oral medications affecting blood glucose. (2) 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 during test periods. (3) Subjects who have declared allergic reaction to test foods or ingredients contained in loading foods. (4) Subjects who are diagnosed as diabetes based on the results of screening test. (5) Subjects who contract, are under treatment for or have a history of serious diseases (e.g., diabetes, kidney disease, liver disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder. (6) Subjects who have a chronic disease and use medications continuously. (7) Subjects who have a history of digestive disease affecting digestion and absorption. (8) Subjects who are judged as unsuitable for the current study based on the results of screening test. (9) Subjects who are diagnosed as anemic and not suitable for frequent collection of blood. (10) Subjects who have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study. (11) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. (12) Subjects who are planning to participate in other clinical studies. (13) Subjects who are planning to become pregnant after informed consent for the current study, are pregnant or lactating. (14) Subjects who are judged as 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 Postprandial blood glucose AUC
- Secondary Outcome Measures
Name Time Method