Adults whose BMI is >
Conditions
Interventions
The subjects take test food (including blueberry extract) 3 tablets once day for 12 weeks.
The subjects take placebo food (not including blueberry extract) 3 tablets once day for 12 weeks.
Sponsors
University of Miyazaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects whose BMI is >= 23 kg/ m2 ,<30 kg/m2 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. Heavy drinkers (drink more than 80 g of alcohol per day), subjects who are dependent on alcohol or drugs, possible alcohol or drug abusers. 6. Subjects who regularly take drugs (anti-dyslipidemia,anti-diabetes etc.), 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 400 ml whole blood within, 200 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 |
|---|---|
| VFA at baseline, after 4 weeks, 8 weeks, 12 weeks and 16 weeks of intervention with test food or placebo food. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Waist circumference 2.BMI, Body weight 3.The actual values and the change from pre-ingestion of glycolipid metabolism related index at each evaluation point (Adiponectin, Triglyceride, HDL-C, LDL-C, insulin, glucose). 4.The amount of activity (Step count, amount of exercise(EX)) 5. The actual values and the change from pre-ingestion of blood index at each evaluation point except 3. 6.Adverse events (They are assessed at baseline, after 4 weeks, 8 weeks, 12 weeks and 16 weeks of intervention with test food or placebo food except adverse events.) | — |
Countries
Japan
Contacts
Public ContactYasuji Arimura
University of Miyazaki Clinical research support center, university of Miyazaki hospital
Outcome results
None listed