Efficacy of Cardioviva™ Probiotic Supplement Capsule Formulation

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: Cardioviva™ supplement capsule
* Dietary Supplement: Placebo capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardioviva™ supplement capsule<br> | Dietary Supplement: Cardioviva™ supplement capsule<br>* Twice per day (BID), 9 weeks<br>|
| Placebo Comparator: Placebo capsule<br> | Dietary Supplement: Placebo capsule<br>* Twice per day (BID), 9 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome will be the percent difference in LDL-cholesterol from baseline to endpoint comparing subjects receiving treatment and placebo |  | 9 weeks |