Efficacy and Tolerability of the Nutraceutical Formulation Coleosoma in Dyslipidemic Subjects
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Coleosoma; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): patients will take one tablet of 500mg daily for 12 weeks. No dose titration is foreseen.; patients will take one tablet daily for 12 weeks.
Other intervention name(s): TegraDOC
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study included two arms: a treatment arm with dietary supplement (Coleosoma) and a placebo arm.
Coleosoma is the name of a new patented dietary supplement composed by Berberin 200 mg, Fermented Red Rice from Monascus purpureus 100 mg (correspondiing at 3 mg of monacolin K), Chitosan 100 mg e Q10 Coenzyme10 mg
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dyslipidemia; dietary supplement