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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

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 - Study of the glucose metabolism-improving effect of test food

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000032837
Enrollment
130
Registered
2018-08-17
Start date
2018-08-17
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia

Interventions

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects giving written informed consent 2. Healthy men and women of 20 to 64 years age 3. Fasted blood glucose levels were 100 to 125 mg/dL and blood HbA1c levels were 5.6 to 6.4 % at the screening period

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Fasted blood glucose, HbA1c

Secondary

MeasureTime frame
Fasted blood insulin Insulin resistance indexes (HOMA-IR, QUICKI) Glycoalbumin Blood inflammatory cytokines, hsCRP Blood adiponectin Blood lipids

Countries

Japan

Contacts

Public ContactEiji Yoshikawa

KSO Corporation Facility Management Department

yoshikawa@kso.co.jp81-3-3452-7733

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026