Efficacy of Cardioviva™ Probiotic Yogurt Formulation

June 29, 2012 updated by: Micropharma Limited

Efficacy of a Microencapsulated Probiotic Yogurt Formulation as a Health Promoting Agent

Background: Several studies have reported limited or no reduction in serum lipid concentrations in response to probiotic formulations. More recently, probiotics have shown promise in treating metabolic disease, due to improved strain selection and delivery technologies.

Objective: To evaluate the lipid lowering efficacy of a yogurt formulation containing microencapsulated Bile Salt Hydrolase (BSH)-active Lactobacillus reuteri cardioviva, taken twice per day over 6 weeks, in subjects with hypercholesterolemia.

Design: This is a double-blinded, multi-centric, placebo-controlled, randomized, parallel-arm study. The study will last a total of 10 weeks including 2-week wash-out, 2-week run-in, and 6- week treatment period.

Study Overview

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2

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 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy males and females.
  • Aged 18-74 years old.
  • Low Density Lipoprotein (LDL-C) above 3.4 mmol/L (<15% variation between visits V1 and V2-1).
  • Triglyceride (TG) levels below 4.0 mmol/l (check at V0 and V2-1).
  • Body Mass Index (BMI) range was 22 to 32 kg/m2.
  • Ability to understand dietary procedures.
  • 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 were permitted to take stable doses of thyroid hormone, anti-hypertensive agents, and contraceptive hormones (e.g. contraceptive pills or patches), as long as these were continued equivalently throughout the duration of study.

Exclusion Criteria:

  • Use of statin or other cholesterol lowering prescription drugs 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 supplements within last 3 months.
  • History of chronic use of alcohol (>2 drinks/day).
  • Use of systemic antibodies, corticosteroids, androgens, or phenytoin.
  • Myocardial infarction, coronary artery bypass, or other major surgical procedures within the last six months.
  • Lactose intolerance or allergies to dairy products.
  • History of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, 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 fiber laxative (greater than 2 doses/week), or stimulant laxatives.
  • History of eating disorders.
  • Exercise greater than 15 miles/week or 4,000 kcal/week.
  • 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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cardioviva™ yogurt
L. reuteri cardioviva in yogurt, twice per day (BID), 6 weeks
PLACEBO_COMPARATOR: Placebo yogurt
yogurt, twice per day (BID), 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome variable will be the percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C)
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

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

Investigators

  • Study Director: Mitchell L Jones, MD, MEng, Micropharma Limited

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

September 1, 2008

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

August 18, 2010

First Submitted That Met QC Criteria

August 19, 2010

First Posted (ESTIMATE)

August 20, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 2, 2012

Last Update Submitted That Met QC Criteria

June 29, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • MP-001

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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