A randomized double-blind, placebo-controlled crossover study to investigate the suppressive effect of blueberry leaf extract on the postprandial triglyceride level elevation.

Not Applicable

• Conditions: Adults

• Registration Number: JPRN-UMIN000030838
• Lead Sponsor: niversity of Miyazaki

Brief Summary

The primary endpoint, IAUC of postprandial triglyceride levels, showed a trend toward a decrease with the blueberry leaf extract-containing (BLE) drink, but there was no statistical difference. However, the secondary endpoints of postprandial triglyceride, RLP-C, and ApoB48 were significantly lower in the BLE drink, suggesting that the blueberry leaf extract-containing drink suppressed postprandial triglyceride absorption (Reported in Clinical study report Version 1 on July 23, 2019).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-16
• Study Completion: 2018-08-07
• Results First Posted: 2019-07-23
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 15

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. 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified