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Efficacy of Cardioviva™ Probiotic Yogurt Formulation

NCT01185795 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2012-07-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Cardioviva™ yogurt

L. reuteri cardioviva in yogurt, twice per day (BID), 6 weeks

DIETARY_SUPPLEMENT

Placebo yogurt

yogurt, twice per day (BID), 6 weeks

Sponsors & Collaborators

  • Micropharma Limited

    lead INDUSTRY

Principal Investigators

  • Mitchell L Jones, MD, MEng · Micropharma Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-01-31
Completion
2009-04-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01185795 on ClinicalTrials.gov