Efficacy and Tolerability of the Nutraceutical Formulation Coleosoma in Dyslipidemic Subjects

The overall objective of the study is to assess the efficacy of Coleosoma formulation (fermented red rice, berberine and chitosan) in reducing non-HDL cholesterol in dyslipidemic patients.

The incidence of cardiovascular diseases related to atherosclerosis is the leading cause of death in industrialized countries and in many developing countries. It becomes, therefore, essential to implement preventive strategies with lifestyle changes in order to prevent / control the risk factors related to cardiovascular disease.

Dyslipidemia is characterized by qualitative and quantitative alterations of plasma lipids and lipoproteins. In subjects where it is not yet indicated a statin therapy, the guidelines recommend a lifestyle (diet and exercise) act to control cardiovascular risk factors.

The formulation Coleosoma is a supplement composed of fermented red rice, berberine and chitosan. Aim of the study is to evaluate the effectiveness of coleosoma formulation in reducing non-HDL cholesterol (Non-HDL-C), which provides a measure of the cholesterol content in all atherogenic particles.

This is a single-center, randomized (3:1) and controlled double-blind phase II study that involve dyslipidemic patients with non-HDL cholesterol levels ≥ 160 mg / dl.

The study included a maximum of 4 visits for all subjects enrolled. All eligible patients at V0 (screening) undergo baseline assessments (V1) and have been allocated according to the procedure of randomization to one of the study arms. Follow-up (FU) visits for all subjects was at 4 (V2) and at 12 weeks (V3) after randomization.

Laboratory and diagnostic:

At each visits patients undergo: anthropometric and hemodynamic assessment: weight and height for Body Mass Index (BMI) calculation, waist circumference, blood pressure, heart rate; blood collection for metabolic/hormonal profile: fasting plasma glucose, HbA1c, insulin, glucagon, active glucagon-like peptide-1 (GLP-1), total gastric inhibitory polypeptide (GIP), total cholesterol, HDL-cholesterol, triglycerides, aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine, creatine phosphokinase (CPK), apolipoprotein (Apo) B, Apo A1, and inflammatory cytokines (IL-1, IL-6, IL-10, high-sensitivity C Reactive Protein (hsPCR), TNFalpha).

At V1 and V2 the Endothelial Progenitor Cells (EPC) number was evaluated with a cytofluorimetric assay.

Safety analysis has been conducted after 12 weeks treatment by determining ALT, CPK and estimated Glomerular filtration rate (eGFR) values.

This study has been sponsored by DOC generici s.r.l.

Eligibility Criteria:
Inclusion Criteria:

* non-HDL cholesterol ≥ 160 mg/dl;
* providing their written Informed Consent;
* capable of understanding the nature, purpose and study procedures

Exclusion Criteria:

* diabetes (ADA criteria)
* reduced renal (GFR\<60 mL/min/1.73m2) or hepatic (transaminase levels \>2.5 folds the upper reference limit) function;
* present or past history of alcohol or drug abuse
* cerebro-vascular and neoplastic diseases in the 5 years prior to study visit
* use of drugs or food supplements interfering with cholesterol levels
* pregnancy or breastfeeding;
* monogenic dyslipidemia;
* participation in other clinical trials in the previous 30 days;
* uncompensated hypothyroidism