Bergamot and Cardio-Metabolic Risk Factors

Completed

• Conditions: Dyslipidemia
• Interventions: Dietary Supplement: Bergamot-derived product

• Registration Number: NCT02205567
• Lead Sponsor: University of Palermo

Brief Summary

Bergamot-derived products have shown significant effects on plasma lipids. We aim in the present study to evaluate the effect of bergamot on several cardio-metabolic risk markers.

Detailed Description

The research hypothesis is to assess whether bergamot reduces plasma lipids (total cholesterol, triglycerides, low-density lipoprotein (LDL)-cholesterol and high-density lipoprotein (HDL)-cholesterol), atherogenic lipoproteins, carotid intima-media thickness (IMT) and liver steatosis in patients with dyslipidemia.

The primary objective is to assess whether bergamot reduces plasma lipids and atherogenic lipoproteins in patients with dyslipidemia.

Primary endpoint: Reduction in plasma lipids and atherogenic lipoproteins. The secondary objective is to assess whether bergamot reduces carotid intima-media thickness (IMT) and liver steatosis in patients with dyslipidemia.

Secondary endpoint: Reduction in IMT and and liver steatosis.

Clinical diagnostic tools will include the measurement of:

1. cIMT, that will be assessed by B-mode real-time ultrasound using a single sonographer (Medison SonoAce Pico, with a probe of 7.5-10.0 MHz) in a standardized manner with fixed angles of insonation;

2. liver steatosis, that will be assessed by by abdominal ultrasound.

Biochemical analyses will include the analysis of:

1. Routine testing of plasma lipids;

2. Atherogenic lipoproteins, e.g. the analysis of 11 distinct lipoproteins including very-low-density lipoprotein (VLDL), 3 intermediate density lipoprotein (IDL) subclasses and 7 low density lipoprotein (LDL) subclasses.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-29
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-07-31
• Primary Completion: 2015-06
• Status Verified: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-05
• Last Update Posted: 2015-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• elevated LDL-cholesterolemia

Exclusion Criteria

• severe hepatic or renal diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Bergamot-derived product	500 mg/day of Bergamot-derived product
Group 2	Bergamot-derived product	1000 mg/day of Bergamot-derived product

Primary Outcome Measures

Name	Time	Method
Change from baseline in plasma lipids	baseline and 6 months	We will measure at baseline and after 6 months the following plasma lipids concentrations: total cholesterol, triglycerides, LDL-cholesterol and HDL-cholesterol.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in atherogenic lipoproteins, carotid intima-media thickness (IMT) and liver steatosis	baseline and 6 months	We will measure at baseline and after 6 months carotid IMT by color doppler ultrasound, atherogenic lipoproteins by electrophoresis and liver steatosis by abdominal ultrasound.

Trial Locations

Locations (1)

University Hospital of Palermo; 🇮🇹 Palermo, PA, Italy