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Verification of the effects of long-term intake of test food on glucose metabolism

Verification of the effects of long-term intake of test food on glucose metabolism: Open-label study - Verification of the effects of long-term intake of test food on glucose metabolism: Open-label study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056318
Enrollment
15
Registered
2024-12-02
Start date
2025-01-28
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

Healthy adults

Interventions

Ingestion the test food for 12 weeks

Sponsors

Miura Clinic, Medical Corporation Kanonkai
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Subjects of healthy men and women aged 30 to 69 (2) Subjects with fasting blood glucose of 110 mg/dL or more and less than 126 mg/dL or blood glucose of 140 mg/dL or more and less than 200 mg/dL after 120 minutes of glucose loading (3) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing

Exclusion criteria

Exclusion criteria: (1) Subjects with a history of diabetes, liver diseases, renal disease, gastrointestinal disease, cardiac disease, respiratory disease, peripheral vascular disease, or other serious disease (2) Subjects who have undergone gastrointestinal surgery (3) Subjects with diseases currently being treated (4) Subjects with HbA1c of 6.5% or higher (5) Subjects who are allergic to food and drugs (6) Subjects with anemia symptoms (7) Female subjects wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female subjects (8) Subjects who play intense sports and subjects who are on a diet (9) Subjects with extremely irregular eating habits (10) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period (11) Subjects who are continuously treated with pharmaceuticals (including OTC and prescription drugs) (12) Subjects who drink more than 40 g of average daily pure alcohol (13) Subjects who are participating in or will participate in other clinical trials at the start of this study (14) Other subjects judged by the investigator or the investigator to be inappropriate for the examination

Design outcomes

Primary

MeasureTime frame
Blood glucose (Fasting blood glucose, Changes in postprandial blood glucose over time, Area under the blood concentration curve (IAUC), Cmax and deltaCmax of blood glucose levels) Insulin (Fasting insulin, Changes in postprandial insulin over time, IAUC, Cmax and deltaCmax of insulin)

Secondary

MeasureTime frame
1,5-Anhydroglucitol (1,5-AG)

Countries

Japan

Contacts

Public ContactMakoto Terashima

Oneness Support Co., Ltd. Clinical Trial Division

mterashima@oneness-sup.co.jp06-4801-8917

Outcome results

None listed

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