Hypercholesterolemia
Conditions
Keywords
Hypercholesterolemia, Food supplement
Brief 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.
Detailed description
In the screening visit subject's demographic data, medical history, co-morbidities and concomitant medication will be collected. Patients with documented hypercholesterolemia (LDL-C values between 115 and 190 mg/dl) will be evaluate. Blood sample analysis will be prescribed to be performed before the next visit for the evaluation of TC, HDL-C, Tg, apoB, fasting plasma glucose (FPG), creatinine, uric acid, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine phosphokinase (CPK). At the baseline visit, a computerized medical record will be compiled where the following data will be recorded: vital signs \[weight, height, BMI, systolic blood pressure (SBP) and diastolic blood pressure (DBP)\] and the laboratory tests (TC, HDL-C, Tg, apoB, FPG, creatinine, uric acid, ALT, AST and CPK). The subjects will be randomized in one of the 2 groups to receive Cynacol or Metacol. A sufficient amount of study product for 90 days will be delivered. Standardized diet and physical activity advice will be prescribed. Blood sample analysis will be prescribed to be performed before the next visit for the evaluation of TC, HDL-C, Tg, apoB, FPG, creatinine, uric acid, ALT, AST and CPK. After 45 days of treatment, following blood samples collection, vital signs and laboratory tests will be recorded. Any adverse events eventually occurred will be collected. After 90 days of treatment, following blood samples collection, vital signs and laboratory tests will be recorded. Any adverse events eventually occurred will be collected. 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.
Interventions
DIETARY_SUPPLEMENTCynacol
Cynacol (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
DIETARY_SUPPLEMENTMetacol
Metacol (developed by BioDue S.p.A.) containing coenzyme Q10, monacolin k and flaxseed oil, 2 capsules/day after dinner for 90 days
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL Cholesterol | 3 months | The primary outcome is to evaluate the change in LDL-C levels after 90 days of supplementation with Cynacol compared to Metacol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipid profile parameters different from LDL | three months | 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 |
Countries
Italy
Outcome results
None listed