Randomized and Comparative Clinical Study on the Lipid-lowering Efficacy and Tolerability of Two Food Supplements in Mild Hypercholesterolemia
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Italy
Fondazione IRCCS Policlinico San Matteo
RECRUITING
Pavia
Time Frame
Start Date: 2025-09-30
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 40
Treatments
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.
Active_comparator: Metacol
Metacol (developed by BioDue S.p.A.) is a dietary supplement containing coenzyme Q10, monacolin k and flax seed oil.
Related Therapeutic Areas
Sponsors
Leads: Fondazione IRCCS Policlinico San Matteo di Pavia