Healthy subjects
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Japanese male and female subjects between the ages of 20 and 65 at the time of written consent. 2. Subjects whose fasted blood glucose levels are 100 mg/dL or more and less than 126 mg/dL or 2-hour glucose value in a 75 g oral glucose tolerance test are 140 mg/dL to 200 mg/dL at the screening period. 3. Subjects who have received a full explanation of the purpose and content of the study, have the ability to consent, understand the study well, and have volunteered to participate in the study and have agreed to participate in the study in writing.
Exclusion criteria
Exclusion criteria: 1. Subjects who have been diagnosed with diabetes by a physician. 2. Subjects who are currently receiving medication or outpatient treatment for some serious disease. 3. Subjects who are currently undergoing exercise or diet therapy under the supervision of a physician. 4. Subjects who may develop allergies to the test food. 5. Subjects who have a current or a history of drug dependence or alcohol dependence. 6. Subjects who are hospitalized for mental disorders (depression, etc.) or sleep disorders(insomnia, sleep apnea, etc.), or have a history of mental disorders in the past. 7. Subjects who are with extremely irregular eating, sleeping, or other habits. 8. Subjects who have an extremely unbalanced diet. 9. Subjects who have or have had serious diseases such as brain diseases, malignant tumors, immune diseases, diabetes, liver diseases (hepatitis), kidney diseases, heart diseases, etc., thyroid diseases, adrenal diseases, and other metabolic diseases. 10. Subject who use health foods and medicines that contain ingredients that affect blood glucose levels. 11. Subjects who have participated in other clinical trials (research) within 3 months retrospectively from the date of obtaining consent, or those who have plans to participate in other clinical trials (research) during the study period 12. Subjects who have collected more than 200 mL of blood within 1 month or 400 mL within 3 months prior to the date of obtaining consent. 13. Subjects who are currently pregnant or breastfeeding. or who are likely to become so during the study period. 14. Subjects who have difficulty in complying with the recording of various questionnaires. 15. Subjects who are judged to be inappropriate as subjects based on clinical laboratory test values and measured values at the time of SCR. 16. Other subjects who are judged unsuitable as subjects by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incremental area under the curve of the postprandial blood glucose | — |
Secondary
| Measure | Time frame |
|---|---|
| "The incremental area under the curve of postprandial blood insulin and triglyceride levels Cmax,delta Cmax, and Tmax of blood glucose, insulin, and triglyceride levels Postprandial questionnaire" | — |
Countries
Japan
Contacts
Medical Corporation Kyoso-kai AMC Nishi-Umeda Clinic Department of Clinical Research Center