Efficacy of a One-a-Day L. Reuteri NCIMB 30242 Probiotic Supplement Capsule
- Conditions
- Hypercholesterolemia
- Interventions
- Dietary Supplement: One-a-Day placebo capsuleDietary Supplement: One-a-Day L. reuteri NCIMB 30242 supplement capsule
- Registration Number
- NCT01630668
- Lead Sponsor
- Micropharma Limited
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description One-a-Day placebo capsule One-a-Day placebo capsule - One-a-Day L. reuteri NCIMB 30242 supplement capsule One-a-Day L. reuteri NCIMB 30242 supplement capsule -
- Primary Outcome Measures
Name Time Method The primary outcome will be the change in serum LDL-cholesterol from baseline to endpoint between control and treatment groups. Week 0 and Week 12 of intervention period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
KGK Synergize Inc.
🇨🇦London, Ontario, Canada