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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Dietary supplement: Cynacol; Dietary supplement: Metacol

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Recruiting
      • Fondazione IRCCS Policlinico San Matteo
      • Contact: Giuseppe Derosa, MD, PhD; Phone Number: +390382502614; Email: g.derosa@smatteo.pv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Active Comparator: Metacol; Metacol (developed by BioDue S.p.A.) is a dietary supplement containing coenzyme Q10, monacolin k and flax seed oil.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL Cholesterol	The primary outcome is to evaluate the change in LDL-C levels after 90 days of supplementation with Cynacol compared to Metacol	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid profile parameters different from LDL	to evaluate the variation of TC, non-HDL cholesterol (non-HDL-C), apolipoprotein B (apoB), Tg, HDL-C after 90 days of treatment with Cynacol compared to Metacol	three months

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Hypercholesterolemia; Food supplement
• Additional Relevant MeSH Terms: Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hypercholesterolemia
• Other Study ID Numbers: CYNACOL-METACOL-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No