Effect of a Food Supplementation With a Combined Food Supplement on Lipid Pattern, Indexes of Non… (NCT06247137) | Clinical Trial Compass
CompletedNot Applicable
Effect of a Food Supplementation With a Combined Food Supplement on Lipid Pattern, Indexes of Non-alcoholic Fatty Liver Disease and Systemic Inflammation
Italy90 participantsStarted 2022-04-01
Plain-language summary
Several controlled interventional studies have shown that there is a close correlation between cholesterol reduction and cardiovascular risk; in fact, reductions in serum levels of total cholesterol and low-density lipoprotein cholesterol (LDL-C), 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-C 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Subjects agree to participate in the study and having dated and signed the informed consent form.
✓. Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.
✓. Male or female aged ≥ 18 years and ≤ 70 years old.
✓. LDL-Cholesterol blood levels \>115 mg/dL and \< 190 mg/dL.
✓. TG\<400 mg/dL.
✓. Subjects who, according to the SCORE charts, have a low or moderate cardiovascular risk (defined as a total cardiovascular risk \< 5%) and for whom, according to ESC/EAS guidelines 2012, the intervention strategy does not require a pharmacological lipid-lowering intervention.
✓. Patient covered by the Social Security scheme.
Exclusion criteria
✕. Subjects already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk\> 5%;
✕
What they're measuring
1
LDL-cholesterolemia reduction from baseline and between groups