Efficacy of Cardioviva™ Probiotic Supplement Capsule Formulation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

APharma s.r.o.

Prague, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Males and females, aged 20 to 75 years (bounds included)
LDL-Cholesterol above 3.4 mmol/L (<15% variation between visits V1 and V2-1)
TG levels below 4.0 mmol/L (checked at visits V0 and V2-1)
BMI range will be 22 to 32 kg/m²
Subject understands and accepts to follow the dietary recommendations advisable for hypercholesterolemic patients (according to NCEP-ATP III guidelines)
For subjects on statin monotherapy: dosage of statin must be stable for at least 3 months prior to the study beginning (15-20% of all subjects)
Judged by the investigators as compliant (>80%) with product consumption (check at V2-1), and motivated
Signed informed consent form prior to inclusion in the study
Note: Subjects will be permitted to take stable doses of thyroid hormone and anti-hypertensive agents, as long as these are continued equivalently throughout the duration of study
For female subjects: effective contraceptive methods used

Exclusion criteria

Use of cholesterol lowering prescription drugs other than statin monotherapy within the last 6 months
Use of plant sterols, omega 3, fish oil, soy protein, soluble oat fiber, psyllium seed husk, or other cholesterol lowering non-prescription food supplements within last 3 months
History of chronic use of alcohol (>2 drinks/d)
Use of systemic antibodies, corticosteroids, androgens, or phenytoin
Subject having experienced any cardiovascular event (Myocardial infarction, coronary artery bypass, or other major surgical procedures) in the last 6 months
Diabetic subject (Type I or Type II)
Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
Subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial
History of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year)
Chronic user of probiotics or fibre laxative (greater than 2 doses/wk), or stimulant laxatives
History of eating disorders
Exercise greater than 15 miles/wk or 4,000 kcal/wk
For female subjects: Pregnancy, breast feeding, or intent to get pregnant

Treatment and study plan

Cardioviva™ supplement capsule

Dietary Supplement

Twice per day (BID), 9 weeks

placebo capsule

Dietary Supplement

Twice per day (BID), 9 weeks

Primary outcomes

The primary outcome will be the percent difference in LDL-cholesterol from baseline to endpoint comparing subjects receiving treatment and placebo

Time frame: 9 weeks

Sponsors and collaborators

Lead sponsor

Micropharma Limited

Industry

Registry information

Official study title

Efficacy of a Supplement Capsule Containing L. Reuteri Cardioviva™ on Managing Cholesterol Levels in Hypercholesterolemic Humans

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Apr 26, 2011
Registry last updated: Nov 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed