Dyslipidemia Clinical Trial
Official title:
The Effect of Bergamot on Plasma Lipids, Lipoproteins and Carotid Intima-media Thickness
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.
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.
;
Observational Model: Case-Only, Time Perspective: Prospective
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