A Study on Antiglycation Effect of Food Containing Plant Extract -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
- Conditions
- o
- Registration Number
- JPRN-UMIN000039948
- 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
- 90
Not provided
(1) Subjects who can't stop using medicines, quasi-medicines, supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting blood glucose or glycation on during test periods. (2) Smokers (3) Subjects who have declared allergic reaction to ingredients of test foods. (4) Subjects who have excessive alcohol intake more than approximately 20 g / day of pure alcohol equivalent or habit of drinking more than 4 days a week. (5) Subjects who can't stop drinking from 2 days before each measurement. (6) Subjects whose daily average sleeping time is less than about 6 hours. (7) Subjects who are shiftworker and/or midnight-shift worker. (8) Subjects who contract or are under treatment for serious diseases (e.g., liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal disease and/or metabolic disease). (9) Subjects who are under chronic disease treatment (10) Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption. (11) Subjects who are judged as unsuitable for the current study by screening test. (12) Subjects who have been pregnant or subjects who have a plan to become pregnant or breast feed during the study period. (13) 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. (14) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. (15) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. (16) 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 Pentosidine
- Secondary Outcome Measures
Name Time Method Other glycation markers