Healthy adults
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time frame |
|---|---|
| 1,5-Anhydroglucitol (1,5-AG) | — |
Countries
Japan
Contacts
Oneness Support Co., Ltd. Clinical Trial Division