Study of the glucose metabolism-improving effect of the 12-week intake of test food containing lactic acid bacteria: A randomized, double-blind, placebo-controlled, parallel-group study
- Conditions
- Hyperglycemia
- Registration Number
- JPRN-UMIN000047804
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 148
Not provided
1. Subjects who take the medicine affecting blood glucose levels 2. Subjects with a habit of taking supplements or health food affecting blood glucose levels in one month before the screening test 3. Subjects with a habit of intake more than twice in a week of fermented milk or lactic fermenting beverage in one month before the screening test 4. Subjects with milk allergy or lactose intolerance 5. Subjects who were diagnosed with diabetes by the screening test 6. Subjects who have been suffering from or under treatment of sever systemic diseases affecting the results of this study 7. Subjects who have chronic illness and who take medication everyday 8. Subjects who were judged unsuitable as subjects by clinical examination at the screening test 9. Subjects who were collected or donated more than 200 mL of blood within a month or more than 400 mL within 3 months before the screening test 10. Subjects who drink a lot of alcohol 11. Subjects who have been drug dependency 12. Subjects who participated in other clinical trials within one month before the agreement of participants in this study 13. Subjects engaged in day/night shift work 14. Subjects who are in pregnancy, in nursing or williing to be pregnant during the test period 15. 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 HbA1c
- Secondary Outcome Measures
Name Time Method Fasted blood glucose Blood glucose after glucose loading Glycoalbumin Fasted blood insulin Blood insulin after glucose loading Insulin resistance indexes (HOMA-IR, QUICKI) Blood cytokines, hsCRP Blood adiponectin Blood lipids