NCT06247137

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

Evaluation of the Effect of a Food Supplementation With a Combined Food Supplement on Lipid Pattern, Indexes of Non-alcoholic Fatty Liver Disease and Systemic Inflammation in Healthy Subjects With Suboptimal LDL-C Levels: a Two-arm Double-blind, Placebo- Controlled, Randomized, Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: University of Bologna · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

• Hypercholesterolemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-04-01
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2024-02-07
• Last updated: 2024-04-26

Locations

1 site across 1 country: Italy