Bergamot and Cardio-Metabolic Risk Factors

University of Palermo

Status: Completed

Conditions: Dyslipidemia

Treatments: Dietary Supplement: Bergamot-derived product

Study type: Observational

Funder types: Other

Identifiers

NCT02205567

BMT14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• elevated LDL-cholesterolemia

Exclusion criteria

• severe hepatic or renal diseases

Trial design

160 participants in 2 patient groups

Group 2

Description:

1000 mg/day of Bergamot-derived product

Treatment:

Dietary Supplement: Bergamot-derived product

Group 1

Description:

500 mg/day of Bergamot-derived product

Treatment:

Dietary Supplement: Bergamot-derived product