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Study of the glucose metabolism-improving effect of the 12-week intake of food containing lactic acid bacteria: A randomized, double-blind, placebo-controlled, parallel-group study

Phase 2
Conditions
Hyperglycemia
Registration Number
JPRN-UMIN000032837
Lead Sponsor
KSO Corporation
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
130
Inclusion Criteria

Not provided

Exclusion Criteria

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 5. Subjects who were diagnosed with diabetes requiring medication by the screening test 6. 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 donated blood of more than 200 mL within a month or more than 400 mL within 3 months 10. Subjects who drink a lot of alcohol 11. Subjects who have been drug dependency or alcohol dependency 12. Subjects who participated in other clinical trials within one month before the agreement of participants in this study 13. Subjects in pregnancy or in nursing 14. 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
NameTimeMethod
Fasted blood glucose, HbA1c
Secondary Outcome Measures
NameTimeMethod
Fasted blood insulin Insulin resistance indexes (HOMA-IR, QUICKI) Glycoalbumin Blood inflammatory cytokines, hsCRP Blood adiponectin Blood lipids
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