Hypercholesterolemia Clinical Trial
Official title:
Efficacy of a Supplement Capsule Containing L. Reuteri Cardioviva™ on Managing Cholesterol Levels in Hypercholesterolemic Humans
Background: It is becoming increasingly clear that individuals from all corners of the globe
use probiotic dietary approaches to enhance health. More recently, probiotics have shown
promise in treating a variety of disease states, due to improved strain selection, stability
and delivery technologies.
Objective: The purpose of this study is to determine the lipid lowering efficacy of a
probiotic supplement capsule containing Lactobacillus reuteri Cardioviva™, taken twice per
day over 9 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 13 weeks, including a 2-week wash-out
period, a 2-week run-in period and a 9 week treatment period.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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