Adults
Conditions
Interventions
The subjects take 100 ml test food containing blueberry extract before meal load.
The subjects take 100 ml placebo food not containing blueberry extract before meal load.
Sponsors
University of Miyazaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who have above 100mg/dL and less than 199mg/dl of fasting triglyceride level. 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 serious respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular and/or mental disease, or who have history of those diseases. 2. Subjects who have 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. Subjects who are heavy alcohol addicts (more than 80 g per day alcohol), or alcohol or drug dependency or who have possibility of the dependency. 6. Subjects who regularly take drugs, which would affect this study. 7. Subjects who regularly take foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study. 8. Subjects who donate either 200 ml whole blood, 400 ml whole blood or blood components within 4 weeks prior to this study. 9. Pregnant or lactating women or women expect to be pregnant during this study. 10. Subjects who have cognitive disorder or who have possibility of the disorder. 11. Subjects who participate and take the study drug in other clinical trials within 4 weeks prior to this study. 12. Subjects who are judged as unsuitable for this study by the principal investigator or subinvestigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incremental area under the curve (IAUC) of postprandial triglyceride level | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.The actual values and the changes of postprandial triglycerides at each evaluation point (1,2,3,4 and 5 hours)after meal load. 2.The increment of postprandial triglyceride level. 3.The actual values and the changes of glycolipid metabolism related index at each evaluation point after meal load. 4.Adverse events. | — |
Countries
Japan
Contacts
Public ContactYasuji Arimura
University of Miyazaki Clinical research support center, University of Miyazaki hospital
Outcome results
None listed