Comparing two supplements (Cynacol vs Metacol) for lowering LDL cholesterol in mild high cholesterol
Randomized and Comparative Clinical Study on the Lipid-lowering Efficacy and Tolerability of Two Food Supplements in Mild Hypercholesterolemia
This test will see if the supplement Cynacol lowers LDL cholesterol more than Metacol in adults aged 35–70 with mild high LDL (115–190 mg/dL).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 35 Years to 70 Years |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Lombardy) |
| Trial ID | NCT07295327 on ClinicalTrials.gov |
What this trial studies
This is a randomized, two-arm, 90-day intervention comparing the effects of Cynacol and Metacol on lipid levels in adults with mild hypercholesterolemia. Participants will have blood tests and vital signs measured at baseline, 45 days, and 90 days, and will receive standardized diet and activity advice. The primary outcome is change in LDL-C after 90 days, with secondary outcomes including total cholesterol, non-HDL-C, apoB, triglycerides, and HDL-C; safety is monitored by recording adverse events and routine labs. Eligible adults (35–70 years) are those with LDL 115–190 mg/dL who are not taking lipid-lowering drugs and without diabetes, significant obesity, or major organ disease.
Who should consider this trial
Good fit: Adults aged 35–70 with LDL cholesterol between 115 and 190 mg/dL who are not on lipid-lowering medications, without diabetes, obesity (BMI ≥30), cardiovascular disease, or major liver/kidney/muscle disorders.
Not a fit: People with very high LDL, diabetes, obesity (BMI ≥30), established cardiovascular disease, or those already taking statins or other lipid-lowering therapies are unlikely to benefit from these supplements in this study context.
Why it matters
Potential benefit: If successful, the supplement could offer a modest, non-prescription option to lower LDL cholesterol for people with mild hypercholesterolemia.
How similar studies have performed: Some prior trials of dietary supplements have shown modest lipid improvements, but direct head-to-head data specifically comparing Cynacol and Metacol are limited or novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pavia, Lombardy
- Fondazione IRCCS Policlinico San Matteo — Pavia, Lombardy, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.