A Phase 2 interventional study of Cardioviva™ yogurt and Placebo yogurt in Hypercholesterolemia, sponsored by Micropharma Limited. Completed. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2012-07-02.
Sponsored by Micropharma Limited · Phase 2, Interventional, and Treatment
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.
1,238 studies on the registry are indexed under Hypercholesterolemia; 110 are open to participants now.
This study's enrollment of 150 is above the median of 100 across 992 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Micropharma Limited is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dietary Supplement: Cardioviva™ yogurt
Dietary Supplement: Placebo yogurt
L. reuteri cardioviva in yogurt, twice per day (BID), 6 weeks
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
No study locations are listed for this record.
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Micropharma Limited