Dyslipidemia
Conditions
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.
Interventions
DIETARY_SUPPLEMENTBergamot-derived product
Group 1: 500mg/day Group 2: 1000mg/day
Sponsors
University of Palermo
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* elevated LDL-cholesterolemia
Exclusion criteria
* severe hepatic or renal diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Outcome results
None listed