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Efficacy of a One-a-Day L. Reuteri NCIMB 30242 Probiotic Supplement Capsule

Phase 2
Completed
Conditions
Hypercholesterolemia
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod

Trial Locations

Locations (1)

KGK Synergize Inc.

🇨🇦

London, Ontario, Canada

KGK Synergize Inc.
🇨🇦London, Ontario, Canada

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