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NCT Number: NCT02205567

Bergamot and Cardio-Metabolic Risk Factors

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.

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Palermo

Palermo, PA, 90127, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elevated LDL-cholesterolemia

Exclusion criteria

  • severe hepatic or renal diseases

Treatment and study plan

Bergamot-derived product

Dietary Supplement

Group 1: 500mg/day Group 2: 1000mg/day

Primary outcomes

  1. Change from baseline in plasma lipids

    Time frame: 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 outcomes

  1. Change from baseline in atherogenic lipoproteins, carotid intima-media thickness (IMT) and liver steatosis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 31, 2014
Registry last updated
Aug 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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