Effect of a Food Supplementation With a Combined Food Supplement on Lipid Pattern, Indexes of Non-alcoholic Fatty Liver Disease and Systemic Inflammation - Trial NCT06247137

Timeline & Enrollment

Primary Outcome

LDL-cholesterolemia reduction from baseline and between groups

Summary

Several controlled interventional studies have shown that there is a close correlation
 between cholesterol reduction and cardiovascular risk; in fact, reductions in the plasma
 concentration of total cholesterol and LDL, obtained through lifestyle modification or
 specific drugs, result in reductions in the incidence of major coronary events. The
 effectiveness of these interventions has been demonstrated both in subjects in primary
 prevention and in subjects in secondary prevention.
 
 Based on this evidence, the National Cholesterol Education Program (NCEP) has defined in the
 ATP III report the target values of LDL cholesterol (C-LDL) to be reached with interventions
 on food and / or pharmacological habits to perform an effective cardiovascular prevention.
 
 Although the atherogenic action of hypercholesterolemia is largely attributable to a direct
 damage exerted on vascular endothelium, recent studies suggest that the activation of a
 low-grade systemic pro-inflammatory state, typical of the patient with cardiovascular risk
 factors, does also play a role in the determinism of endothelial damage and atheroma
 degeneration of the arteries. It is believed that this systemic inflammation, as documented
 by the determination of some humoral signs of inflammation (e.g. C-reactive protein,
 interleukin-6, tumor necrosis factor-α), may further contribute to an increase of
 cardiovascular risk.
 
 The inflammatory state can modulate the atherosclerotic process at various levels,
 determining endothelial activation, promoting leukocyte chemotaxis in the sub-intimal space
 of the arterial wall and therefore the formation of an atheromatous plaque rich in
 inflammatory cells; the latter represents the lesion responsible for the vast majority of the
 coronary and cerebrovascular events observed in subjects with cardiovascular risk factors.

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