Efficacy of Cardioviva™ Probiotic Yogurt Formulation
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.
|Hypercholesterolemia||Dietary Supplement: Cardioviva™ yogurt Dietary Supplement: Placebo yogurt||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy of a Microencapsulated Probiotic Yogurt Formulation as a Health Promoting Agent|
- The primary outcome variable will be the percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) [ Time Frame: 6 weeks ]
|Study Start Date:||September 2008|
|Study Completion Date:||April 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
|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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01185795
|Study Director:||Mitchell L Jones, MD, MEng||Micropharma Limited|