Bergamot and Cardio-Metabolic Risk Factors

Dyslipidemia Clinical Trial

Official title:

The Effect of Bergamot on Plasma Lipids, Lipoproteins and Carotid Intima-media Thickness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02205567
• Other study ID #: BMT14
• Status: Completed
• Phase: N/A
• First received: July 29, 2014
• Last updated: August 5, 2015
• Start date: June 2014
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• elevated LDL-cholesterolemia

Exclusion Criteria:

• severe hepatic or renal diseases

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Dietary Supplement:
• Bergamot-derived product
Group 1: 500mg/day Group 2: 1000mg/day

Locations

Country	Name	City	State
Italy	University Hospital of Palermo	Palermo	PA

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in plasma lipids	We will measure at baseline and after 6 months the following plasma lipids concentrations: total cholesterol, triglycerides, LDL-cholesterol and HDL-cholesterol.	baseline and 6 months	No
Secondary	Change from baseline in atherogenic lipoproteins, carotid intima-media thickness (IMT) and liver steatosis	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.	baseline and 6 months	No