Healthy adult
Conditions
Interventions
The subjects take one test food (low carbohydrate cake).
The subjects take one placebo food (normal carbohydrate cake).
Sponsors
University of Miyazaki
Miyazaki Diabetes Prevention Clinic
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 abnormality in clinical problems 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 respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular and/or mental disease, or who have history of those disease. 2.Subjects who had a serious injury or surgical history within 12 weeks prior to this study. 3.Pre-or post-menopausal women having obvious changes in physical condition. 4.Subjects who have history of allergic reaction to foods or drugs which needs its treatment or who have possibility of the reaction. 5.Heavy smokers (more than 21 cigarettes per day), alcohol addicts (more than 20g per day alcohol), subjects who are alcohol or drug dependence, subjects who are suspected of alcohol or drug dependence. 6.Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study. 7.Subjects donate either 400ml or 200ml whole blood or blood component within four weeks prior to this study. 8.Subjects who are pregnant or lactating, or subjects who expect to be pregnant during this study. 9.Subjects who have cognitive disorder or who have possibility of the disorder. 10.Subjects who participated and took the study drug in other clinical trials within four weeks prior to this study. 11.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 60 minutes after taking the test food or placebo food. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The actual values and the changes of blood glucose level at at baseline, 30min,60min,90min and 120minutes after taking the test food or placebo food. 2.The incremental area under the curve of the postprandial blood glucose and insulin. The maximum levels of the postprandial blood glucose and insulin. 3.The actual values and the changes of triglyceride and free fatty acid at each evaluation point after the intervention of the cakes. 4. The incremental area under the curve and the maximum level of triglyceride and free fatty acid. 5.The actual values and the change of glycolipid metabolism related index at each evaluation point except from one to four (RLP-C, ApoB48, insulin, active GLP-1). 6.The correct answer rate that the examination food is test food or not. 7. Satisfaction of the cake as test food or placebo food. 8.Adverse events. | — |
Countries
Japan
Contacts
Public ContactYasuji Arimura
University of Miyazaki Clinical research support center, University of Miyazaki hospita
Outcome results
None listed