Efficacy of Cardioviva™ Probiotic Supplement Capsule Formulation

November 1, 2011 updated by: Micropharma Limited

Efficacy of a Supplement Capsule Containing L. Reuteri Cardioviva™ on Managing Cholesterol Levels in Hypercholesterolemic Humans

Background: It is becoming increasingly clear that individuals from all corners of the globe use probiotic dietary approaches to enhance health. More recently, probiotics have shown promise in treating a variety of disease states, due to improved strain selection, stability and delivery technologies.

Objective: The purpose of this study is to determine the lipid lowering efficacy of a probiotic supplement capsule containing Lactobacillus reuteri Cardioviva™, taken twice per day over 9 weeks, in subjects with hypercholesterolemia.

Design: The study design is a double-blinded, placebo-controlled, randomized, parallel-arm, multi-centre study. The study will last a total of 13 weeks, including a 2-week wash-out period, a 2-week run-in period and a 9 week treatment period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

131

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

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

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females, aged 20 to 75 years (bounds included)
  • LDL-Cholesterol above 3.4 mmol/L (<15% variation between visits V1 and V2-1)
  • TG levels below 4.0 mmol/L (checked at visits V0 and V2-1)
  • BMI range will be 22 to 32 kg/m²
  • Subject understands and accepts to follow the dietary recommendations advisable for hypercholesterolemic patients (according to NCEP-ATP III guidelines)
  • For subjects on statin monotherapy: dosage of statin must be stable for at least 3 months prior to the study beginning (15-20% of all subjects)
  • Judged by the investigators as compliant (>80%) with product consumption (check at V2-1), and motivated
  • Signed informed consent form prior to inclusion in the study
  • Note: Subjects will be permitted to take stable doses of thyroid hormone and anti-hypertensive agents, as long as these are continued equivalently throughout the duration of study
  • For female subjects: effective contraceptive methods used

Exclusion Criteria:

  • Use of cholesterol lowering prescription drugs other than statin monotherapy within the last 6 months
  • Use of plant sterols, omega 3, fish oil, soy protein, soluble oat fiber, psyllium seed husk, or other cholesterol lowering non-prescription food supplements within last 3 months
  • History of chronic use of alcohol (>2 drinks/d)
  • Use of systemic antibodies, corticosteroids, androgens, or phenytoin
  • Subject having experienced any cardiovascular event (Myocardial infarction, coronary artery bypass, or other major surgical procedures) in the last 6 months
  • Diabetic subject (Type I or Type II)
  • Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
  • Subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial
  • History of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year)
  • Chronic user of probiotics or fibre laxative (greater than 2 doses/wk), or stimulant laxatives
  • History of eating disorders
  • Exercise greater than 15 miles/wk or 4,000 kcal/wk
  • For female subjects: Pregnancy, breast feeding, or intent to get pregnant

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
Placebo Comparator: Placebo capsule
Dietary supplement: Placebo capsule
Twice per day (BID), 9 weeks
Experimental: Cardioviva™ supplement capsule
Dietary supplement: Cardioviva™ supplement capsule
Twice per day (BID), 9 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome will be the percent difference in LDL-cholesterol from baseline to endpoint comparing subjects receiving treatment and placebo
Time Frame: 9 weeks
9 weeks

Collaborators and Investigators

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

Sponsor

Micropharma Limited

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

May 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

April 22, 2011

First Submitted That Met QC Criteria

April 22, 2011

First Posted (Estimate)

April 26, 2011

Study Record Updates

Last Update Posted (Estimate)

November 2, 2011

Last Update Submitted That Met QC Criteria

November 1, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-0110

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.

Clinical Trials on Hypercholesterolemia

Clinical Trials on Cardioviva™ supplement capsule

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe