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Clinical Trials in Italy / NCT07295327
Recruiting Not applicable

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

NCT07295327 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Phase
Not applicable
Started
2025-09-30
Last updated
2025-12-19

Condition(s) studied

Hypercholesterolemia

Investigational drug(s) / intervention(s)

CynacolMetacol

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

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

Study summary

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.

Eligibility

Sex
ALL
Min age
35 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fondazione IRCCS Policlinico San Matteo Pavia Lombardy Recruiting

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A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events Starting soon
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07295327 on ClinicalTrials.gov ↗ ← All trials in Italy