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

NCT06247137 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-04-26

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Dietary Supplement

Dietary supplement formulated with components of natural origin: artichoke, bergamot, folic acid, astaxanthin, Chromium picolinate and excipients. Oral administration: 1 tablet/day at evening meal

OTHER

Placebo

Placebo (microcrystalline cellulose, calcium carbonate, magnesium stearate, silica dioxide and iron oxides). Oral administration: 1 tablet/day at evening meal.

Sponsors & Collaborators

  • University of Bologna

    lead OTHER

Principal Investigators

  • Claudio Borghi, MD · University of Bologna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2022-12-30
Completion
2022-12-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06247137 on ClinicalTrials.gov