NCT06247137

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

Completed NA Last updated 26 April 2024

What this trial tests

NA trial testing Dietary Supplement in Hypercholesterolemia in 90 participants. Completed in 30 December 2022.

Timeline

1 April 2022

Primary endpoint
30 December 2022

30 December 2022

Quick facts

Lead sponsor	University of Bologna
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	90
Start date	1 April 2022
Primary completion	30 December 2022
Estimated completion	30 December 2022
Sites	1 location across Italy

Drugs / interventions tested

• Dietary Supplement — full drug profile →
• Placebo

Conditions studied

• Hypercholesterolemia — all drugs for Hypercholesterolemia →

Sponsor

University of Bologna

Who can join

Adults 18 to 70, any sex, with Hypercholesterolemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Randomized, Double-Blind, Placebo-Controlled Clinical Trial on the Effect of a Dietary Supplement Containing Dry Artichoke and Bergamot Extracts on Metabolic and Vascular Risk Factors in Individuals with Suboptimal Cholesterol Levels.
   Fogacci F, Giovannini M, Di Micoli A, Fiorini G, et al · · 2024 · cited 4× · PMID 38892519 · DOI 10.3390/nu16111587