RECRUITINGINTERVENTIONAL

Effect of Two Food Supplements on Lipid Profile in Patients With Mild Hypercholesterolemia

Randomized and Comparative Clinical Study on the Lipid-lowering Efficacy and Tolerability of Two Food Supplements in Mild Hypercholesterolemia

About This Trial

The primary outcome is to evaluate the effect of Cynacol on the change in LDL-C levels compared to Metacol after 90 days of supplementation. The secondary outcomes are to evaluate: \- the change of TC, non-HDL cholesterol (non-HDL-C), apolipoprotein B (apoB), Tg, HDL-C levels after 90 days of supplementation with Cynacol compared to Metacol. The safety outcome is collection of the adverse events not related, related or possibly related to the study products.

Who May Be Eligible (Plain English)

Who May Qualify: - age between 35-70 years - both genders - LDL-C levels between 115 and 190 mg/dl - subjects able to understand the willing to sign a consent form and sign it before enrollment in the study Who Should NOT Join This Trial: - personal history of cardiovascular disease or equivalent risk factors - Tg levels ≥ 400 mg/dl - obesity \[body mass index (BMI) ≥ 30 kg/m²\] - taking hypolipidemic drugs or supplements that affect lipid metabolism - diabetes mellitus - known thyroid, liver, kidney or muscle diseases - any medical or surgical condition that makes patient compliance with the study protocol complex or inconsistent - any known allergy or hypersensitivity to one or more components of the food supplements Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * age between 35-70 years * both genders * LDL-C levels between 115 and 190 mg/dl * subjects able to understand the informed consent and sign it before enrollment in the study Exclusion Criteria: * personal history of cardiovascular disease or equivalent risk factors * Tg levels ≥ 400 mg/dl * obesity \[body mass index (BMI) ≥ 30 kg/m²\] * taking hypolipidemic drugs or supplements that affect lipid metabolism * diabetes mellitus * known thyroid, liver, kidney or muscle diseases * any medical or surgical condition that makes patient compliance with the study protocol complex or inconsistent * any known allergy or hypersensitivity to one or more components of the food supplements

Treatments Being Tested

DIETARY_SUPPLEMENT

Cynacol

Cynacol (developed by BioDue S.p.A.) containing, artichoke dry extract, naringin, Silybum marianum dry extract, flaxseed oil, vitamin E and sunflower oil, 2 capsules/day after dinner for 90 days

DIETARY_SUPPLEMENT

Metacol

Metacol (developed by BioDue S.p.A.) containing coenzyme Q10, monacolin k and flaxseed oil, 2 capsules/day after dinner for 90 days

Locations (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, Italy