Efficacy and Tolerability of the Nutraceutical Formulation Coleosoma in Dyslipidemic Subjects (Coleosoma)

January 19, 2017 updated by: Alessandra Dei Cas, Azienda Ospedaliero-Universitaria di Parma

Randomized Controlled Clinical Trial for Assessing Tolerability and Effectiveness of Formula Coleosoma 29 in Patients With Dyslipidemia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Parma, Italy, 43126
        • Endocrinology Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: coleosoma
coleosoma 500mg tablet daily
Dietary supplement: Coleosoma
patients will take one tablet of 500mg daily for 12 weeks. No dose titration is foreseen.
Other Names:
  • TegraDOC
Placebo Comparator: placebo
placebo tablets
Dietary supplement: Placebo
patients will take one tablet daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline values of non-HDL cholesterol (mg/dl) after 12 weeks of coleosoma treatment vs placebo
Time Frame: 12 weeks
Difference in the non-HDL cholesterol value compared to baseline in the 2 arms.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline values of non-HDL cholesterol (mg/dl) at 4 weeks of coleosoma treatment vs placebo
Time Frame: 4 weeks
Difference in the non-HDL cholesterol value compared to baseline in the 2 arms.
4 weeks
change from baseline values of Free Plasma Glucose (mg/dl) at 12 weeks of coleosoma treatment vs placebo
Time Frame: 12 weeks
Difference in the Free Plasma Glucose value compared to baseline in the 2 arms.
12 weeks
change from baseline values of Body Mass Index (Kg/m2) at 12 weeks of coleosoma treatment vs placebo
Time Frame: 12 weeks
Difference in the BMI value compared to baseline in the 2 arms.
12 weeks
change from baseline values of waist circumference (cm) at 12 weeks of coleosoma treatment vs placebo
Time Frame: 12 weeks
Difference in the waist circumference value compared to baseline in the 2 arms.
12 weeks
Change from baseline values of HbA1C (%) at 12 weeks of coleosoma treatment vs placebo
Time Frame: 12 weeks
Difference in the HbA1C value compared to baseline in the 2 arms.
12 weeks
Change from baseline values of LDL Cholesterol, triglycerides and HDL cholesterol at 12 weeks of coleosoma treatment vs placebo
Time Frame: 12 weeks

Difference in theLDL Cholesterol, triglycerides and HDL cholesterol value compared to baseline in the 2 arms.

All these parameters have the same Units of Measure (mg/dl)
12 weeks
Change from baseline values of ApoB/Apo A1 ratio at 12 weeks of coleosoma treatment vs placebo
Time Frame: 12 weeks
Difference in the ApoB/Apo A1ratio compared to baseline in the 2 arms.
12 weeks
Change from baseline values of inflammatory cytokines (IL-1, IL6, IL-10, hsPCR, TNFalpha ) at 12 weeks of coleosoma treatment vs placebo
Time Frame: 12 weeks

Difference in the inflammatory cytokines value compared to baseline in the 2 arms.

All these parameters have the same Units of Measure (pg/ml)
12 weeks
Change from baseline values of insulin (pmol/l) at 12 weeks of coleosoma treatment vs placebo
Time Frame: 12 weeks
Difference in the insulin value compared to baseline in the 2 arms.
12 weeks
Change from baseline values of hormone profile (glucagon, active GLP-1 and GIP) at 12 weeks of coleosoma treatment vs placebo
Time Frame: 12 weeks
Difference in the hormone profile compared to baseline in the 2 arms. All these parameters have the same Units of Measure (pg/ml)
12 weeks
Change from baseline values of Endothelial Progenitor Cells (EPC) number at 12 weeks of coleosoma treatment vs placebo
Time Frame: 12 weeks
Difference in the EPC number compared to baseline in the 2 arms.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria di Parma

Collaborators

DOC generici srl

Investigators

  • Principal Investigator: Alessandra Dei Cas, MD, University of Parma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

January 19, 2017

First Posted (Estimate)

January 23, 2017

Study Record Updates

Last Update Posted (Estimate)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COLEOSOMA 29-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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