NCT06692777

Evaluation of the Hypolipidemic Effect of Bergavit by a Human Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Chung Shan Medical University · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Bergavit is a product contains bergamot. Bergamot is an endemic plant of the Calabrian region in southern Italy with a unique profile of flavonoids and flavonoid glycosides present in its juice and albedo, its flavonoids was able to reduce serum levels of lipids and ameliorate the thickening of the arteries through modulating enzymatic activities, anti-oxidation, anti-inflammatory mechanisms and inhibition of monocyte activation and proliferation.The primary outcome of the study the assessment of the the hypolipidemic effect of Bergavit. The secondary outcomes are the assessment of: a) the hypoglycemic effect of Bergavit, b) the activity of Bergavit on weight loss, and c) the hepatoprotective activity of Bergavit.

Detailed description

The study duration is 4 months. Subjects will attend clinic visits as follows: * T0: First visit: assessment of all baseline parameters, Beginning of treatment * T2: Second visit: assessment only of LDL level, Total cholesterol, ox-LDL, Triglycerides level, fasting glucose. * T3: Third visit: assessment of all parameters. * T4: Fourth visit: assessment of all parameters, end of the treatment.

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bergavit	Subjects treated with Bergavit capsule intake of 150 mg/die of pure flavonoids for 4 months.
DIETARY_SUPPLEMENT	Placebo	Subjects will take capsule equivalent amount of maltodextrin for 4 months.

Timeline

• Start date: 2023-10-21
• Primary completion: 2024-09-30
• Completion: 2024-10-31
• First posted: 2024-11-18
• Last updated: 2024-11-18

Locations

1 site across 1 country: Taiwan