Healthy adult
Conditions
Interventions
The subjects take 125 ml of purple sweet potato concentrated beverage before meal load.
The subjects take 125 ml of placebo beverage before meal load.
Sponsors
University of Miyazaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who are judged as healthy by self-reported health questionnaire. 2. Subjects who have no clinical abnormality by screening tests. 3. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Exclusion criteria
Exclusion criteria: 1. Subjects who have diabetic type blood abnormality at the time of screening test (fasting glucose level of 126mg/dL or more, casual glucose level of 200mg/dL or more, or HbA1c(NGSP) of 6.5% or more). 2. Subjects who have a history of laparotomy or ileus. 3. Subjects who have chronic bowel disease with digestive and absorption disorders. 4. Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular and/or mental disease, or who have history of those diseases. 5. Subjects who had a serious injury or surgical history within 12 weeks prior to this study. 6. Pre-or post-menopausal women having obvious changes in physical condition. 7. Subjects who have history of allergic reaction to foods (especially potatoes, sesame, etc.) or drugs which needs its treatment or who have possibility of the reaction. 8. Heavy smokers (more than 21 cigarettes per day), alcohol addicts (more than 80g per day alcohol), subjects who are alcohol or drug dependence, subjects who are suspected of alcohol or drug dependence. 9. Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study. 10. Subjects donate either 400ml or 200ml whole blood or blood component within four weeks prior to this study. 11. Subjects who are pregnant or lactating, or subjects who expect to be pregnant during this study. 12. Subjects who have cognitive disorder or who have possibility of the disorder. 13. Subjects who participated and took the study drug in other clinical trials within four weeks prior to this study. 14. Subjects who are judges as unsuitable for this study by the principal invesetigator or subinvestigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The blood glucose level at 30 minutes after meal lord. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The actual values (excluding 30min after a meal) and the changes of blood glucose level at 30min, 60min, 90min and 120 minutes after food ingestion. 2. The actual values and the changes of blood insulin level at 30min, 60min, 90min and 120 minutes after meal lord. 3. The incremental area under the curve of the postprandial blood glucose and insulin. The maximum levels of the postprandial blood glucose and insulin. 4. The actual values and the changes of triglyceride and free fatty acid at each evaluation point after meal lord. 5. The incremental area under the curve and the maximum level of triglyceride and free fatty acid. 6.The actual values and the change of blood test index related to glycolipid metabolism at each evaluation point except above mentioned (RLP-C, ApoB48, active GLP-1, active GIP). 7. Adverse events. | — |
Countries
Japan
Contacts
Public ContactYasuji Arimura
University of Miyazaki Clinical research support center, University of Miyazaki hospital
Outcome results
None listed