Efficacy of a One-a-Day L. Reuteri NCIMB 30242 Probiotic Supplement Capsule
NCT01630668 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2014-06-26
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.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
One-a-Day L. reuteri NCIMB 30242 supplement capsule
Once per day, 12 weeks
- DIETARY_SUPPLEMENT
-
One-a-Day placebo capsule
Once per day, 12 weeks
Sponsors & Collaborators
-
Micropharma Limited
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-08-31
- Primary Completion
- 2013-12-31
- Completion
- 2014-06-30
Countries
- Canada
Study Locations
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