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Efficacy of Cardioviva™ Probiotic Supplement Capsule Formulation

NCT01341613 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2011-11-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Cardioviva™ supplement capsule

Twice per day (BID), 9 weeks

DIETARY_SUPPLEMENT

Placebo capsule

Twice per day (BID), 9 weeks

Sponsors & Collaborators

  • Micropharma Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01341613 on ClinicalTrials.gov