Healthy adults
Conditions
Interventions
Ingestion the test food for 12 weeks
Ingestion the placebo food for 12 weeks
Sponsors
Miura Clinic, Medical Corporation Kanonkai
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Subjects of healthy men and women aged 20 to 64 (2) Subjects with fasting blood glucose of 110-125 mg/dL or HbA1c of 5.6% to 6.4%, or blood glucose of 140-199 mg/dL at 120 minutes after meal (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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactMakoto Terashima
Oneness Support Co., Ltd. Clinical Trial Division
Outcome results
None listed