Effect of daily consumption of blueberry leaf extract on visceral fat area (VFA) for 12 weeks :A randomized, double-blind, placebo-controlled comparison group study.

Not Applicable

• Conditions: Adults whose BMI is > = 23 kg/ m2 ,< 30 kg/m2

• Registration Number: JPRN-UMIN000033070
• Lead Sponsor: niversity of Miyazaki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-21
• Study Completion: 2019-01-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VFA at baseline, after 4 weeks, 8 weeks, 12 weeks and 16 weeks of intervention with test food or placebo food.

Secondary Outcome Measures

Name	Time	Method
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.)