Efficacy of Cardioviva™ Probiotic Yogurt Formulation
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|ClinicalTrials.gov Identifier: NCT01185795|
Recruitment Status : Completed
First Posted : August 20, 2010
Last Update Posted : July 2, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia||Dietary Supplement: Cardioviva™ yogurt Dietary Supplement: Placebo yogurt||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of a Microencapsulated Probiotic Yogurt Formulation as a Health Promoting Agent|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||April 2009|
|Experimental: Cardioviva™ yogurt||
Dietary Supplement: Cardioviva™ yogurt
L. reuteri cardioviva in yogurt, twice per day (BID), 6 weeks
|Placebo Comparator: Placebo yogurt||
Dietary Supplement: Placebo yogurt
yogurt, twice per day (BID), 6 weeks
- The primary outcome variable will be the percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) [ Time Frame: 6 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01185795
|Study Director:||Mitchell L Jones, MD, MEng||Micropharma Limited|