Bergamot and Cardio-Metabolic Risk Factors

Study Overview
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Brief Summary
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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
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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: 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; liver steatosis, that will be assessed by by abdominal ultrasound. Biochemical analyses will include the analysis of: Routine testing of plasma lipids; 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.

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

Conditions
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Dyslipidemia

Intervention / Treatment
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* Dietary Supplement: Bergamot-derived product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elevated LDL-cholesterolemia Exclusion Criteria: severe hepatic or renal diseases

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 2<br>1000 mg/day of Bergamot-derived product | Dietary Supplement: Bergamot-derived product<br>* Group 1: 500mg/day Group 2: 1000mg/day<br>|
| Group 1<br>500 mg/day of Bergamot-derived product | Dietary Supplement: Bergamot-derived product<br>* Group 1: 500mg/day Group 2: 1000mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |