Actively Recruiting
Randomized and Comparative Study on the Lipid-lowering Effects and Tolerability of Two Food Supplements in Mild Hypercholesterolemia
Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2025-12-19
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of two dietary supplements, Cynacol and Metacol, on patients with mild hypercholesterolemia. The study aims to compare how these supplements influence LDL cholesterol (LDL-C) levels after 90 days of use. Secondary goals include assessing changes in total cholesterol (TC), non-HDL cholesterol, apolipoprotein B (apoB), triglycerides (Tg), and HDL cholesterol, while monitoring for any adverse events related to the supplements. Participants will be randomized into two groups: one receiving Cynacol, which contains artichoke dry extract, naringin, Silybum marianum dry extract, flaxseed oil, vitamin E, and sunflower oil; the other receiving Metacol, which contains coenzyme Q10, monacolin K, and flaxseed oil. Both supplements are taken as two capsules daily after dinner for a 90-day period. Standardized diet and physical activity advice will be provided alongside supplementation. During the study, participants will have several visits including screening, baseline, and follow-ups at 45 and 90 days. At these visits, medical history, vital signs, and blood samples will be collected to measure lipid profiles and other laboratory tests. Researchers will track changes in cholesterol levels and monitor for any adverse events. The study duration for each participant is approximately 3 months, focusing on the changes in lipid levels and supplement safety.
CONDITIONS
Brief Title
Effect of Two Food Supplements on Lipid Profile in Patients With Mild Hypercholesterolemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 35 and 70 years
- Both genders
- LDL cholesterol levels between 115 and 190 mg/dl
- Able to understand and sign the informed consent before enrollment
You will not qualify if you...
- Personal history of cardiovascular disease or equivalent risk factors
- Triglyceride levels equal to or greater than 400 mg/dl
- Obesity with body mass index (BMI) of 30 kg/m² or higher
- Taking cholesterol-lowering drugs or supplements affecting lipid metabolism
- Diabetes mellitus
- Known thyroid, liver, kidney, or muscle diseases
- Any medical or surgical condition that complicates compliance with the study protocol
- Known allergy or hypersensitivity to any components of the food supplements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 90 days
Participants receive one of two dietary supplements daily and follow standardized diet and physical activity advice while their lipid profiles and vital signs are monitored.
3 visits (in-person) including baseline, 45-day, and 90-day visits
Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy, 27100
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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