Effect of Two Food Supplements on Lipid Profile in Patients With Mild Hypercholesterolemia
Recruiting · NCT07295327 · Interventional (participants receive a specific treatment) · Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
View the official record on ClinicalTrials.gov →Interventions studied
CynacolMetacol
What this trial is about
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.
Who can take part
Age range
35 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Fondazione IRCCS Policlinico San Matteo - Pavia, Lombardy, Italy