Efficacy of a One-a-Day L. Reuteri NCIMB 30242 Probiotic Supplement Capsule
Efficacy of a One-a-Day L. Reuteri NCIMB 30242 Probiotic Supplement Capsule
NCT ID: NCT01630668 Phase: PHASE2 Status: COMPLETED Enrollment: 150 Completion: 2014-06
Conditions
Hypercholesterolemia
Interventions
One-a-Day L. reuteri NCIMB 30242 supplement capsule, One-a-Day placebo capsule
Summary
Background: In recent years, probiotics have shown promise in treating a variety of diseases. Previously, the investigators have reported on the clinical efficacy of Lactobacillus reuteri NCIMB 30242 in improving the lipid profile in hypercholesterolemic adults.
Objective: The purpose of the study is to determine the lipid lowering efficacy of a One-a-Day probiotic supplement capsule containing Lactobacillus reuteri NCIMB 30242 over 12 weeks in subjects with hypercholesterolemia.
Design: The study design is a double-blinded, placebo-controlled, randomized, parallel-arm, multi-centre study. The study will last a total of 14 weeks, including a 2-week run-in period and a 12-week intervention period.
Primary Outcome
The primary outcome will be the change in serum LDL-cholesterol from baseline to endpoint between control and treatment groups.