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

NCT ID: NCT07295327

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-03-31

Brief 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.

Detailed Description

In the screening visit subject's demographic data, medical history, co-morbidities and concomitant medication will be collected. Patients with documented hypercholesterolemia (LDL-C values between 115 and 190 mg/dl) will be evaluate. Blood sample analysis will be prescribed to be performed before the next visit for the evaluation of TC, HDL-C, Tg, apoB, fasting plasma glucose (FPG), creatinine, uric acid, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine phosphokinase (CPK). At the baseline visit, a computerized medical record will be compiled where the following data will be recorded: vital signs [weight, height, BMI, systolic blood pressure (SBP) and diastolic blood pressure (DBP)] and the laboratory tests (TC, HDL-C, Tg, apoB, FPG, creatinine, uric acid, ALT, AST and CPK). The subjects will be randomized in one of the 2 groups to receive Cynacol or Metacol. A sufficient amount of study product for 90 days will be delivered. Standardized diet and physical activity advice will be prescribed. Blood sample analysis will be prescribed to be performed before the next visit for the evaluation of TC, HDL-C, Tg, apoB, FPG, creatinine, uric acid, ALT, AST and CPK. After 45 days of treatment, following blood samples collection, vital signs and laboratory tests will be recorded. Any adverse events eventually occurred will be collected. After 90 days of treatment, following blood samples collection, vital signs and laboratory tests will be recorded. Any adverse events eventually occurred will be collected. 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.

Conditions

Hypercholesterolemia

Keywords

Hypercholesterolemia; Food supplement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cynacol

Cynacol (developed by BioDue S.p.A.) is a dietary supplement containing, artichoke dry extract, naringin, Silybum marianum dry extract, flaxseed oil, vitamin E and sunflower oil.

Group Type: EXPERIMENTAL

Cynacol

Intervention Type: DIETARY_SUPPLEMENT

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.) is a dietary supplement containing coenzyme Q10, monacolin k and flax seed oil.

Group Type: ACTIVE_COMPARATOR

Metacol

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Giuseppe Derosa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Giuseppe Derosa, MD, PhD

Role: primary

Other Identifiers

CYNACOL-METACOL-2025

Identifier Type: -

Identifier Source: org_study_id