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

UMIN ID: UMIN000054276

Registered date:07/05/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2024/07/23
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Ingestion the test food for 12 weeks
Ingestion the placebo food for 12 weeks

Outcome(s)

• Primary Outcome: Fasting blood glucose HbA1c Area under the blood concentration curve (IAUC) of postprandial blood glucose and changes over time Maximum drug concentration and change in maximum drug of concentration on blood glucose level Plasma pentosidine Carboxymethyllysine
• Secondary Outcome: Fasting insulin Area under the blood concentration curve (IAUC) of postprandial insulin and changes over time Maximum drug concentration and change in maximum drug of concentration on insulin Urinary 8-OHdG Homeostasis model assessment of insulin resistance

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 64years-old
• Gender: Male and Female
• Exclude 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 who are allergic to food and drugs (5) Subjects with anemia symptoms (6) Female subjects wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female subjects (7) Subjects who play intense sports and subjects who are on a diet (8) Subjects with extremely irregular eating habits s (9) 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 (10) Subjects who are continuously treated with pharmaceuticals (including OTC and prescription drugs) (11) Subjects who drink more than 60 g of average daily pure alcohol (12) Subjects who are participating in or will participate in other clinical trials at the start of this study. (13) Other subjects judged by the investigator or the investigator to be inappropriate for the examination

Related Information

• Primary Sponsor: Miura Clinic, Medical Corporation Kanonkai
• Source(s) of Monetary Support: TOWA PHARMACEUTICAL CO.,LTD