About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Cynacol
Dietary supplementCynacol (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
Dietary supplementMetacol (developed by BioDue S.p.A.) containing coenzyme Q10, monacolin k and flaxseed oil, 2 capsules/day after dinner for 90 days
Treatment groups
Trial outcomes
Primary outcomes
LDL Cholesterol
The primary outcome is to evaluate the change in LDL-C levels after 90 days of supplementation with Cynacol compared to Metacol
Secondary outcomes
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
Sponsors and contacts
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