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

NCT07295327 | Recruiting DMC

• 1 other identifier: CYNACOL-METACOL-2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia

Keywords

Hypercholesterolemia; Food supplement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Lipid profile parameters different from LDL

  three months

Study Arms (2)

Cynacol

EXPERIMENTAL

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

Metacol

ACTIVE COMPARATOR

Metacol (developed by BioDue S.p.A.) is a dietary supplement containing coenzyme Q10, monacolin k and flax seed oil.

Dietary Supplement: Metacol

Interventions

Cynacol 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

Cynacol

Metacol 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

Metacol

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: September 30, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)