Efficacy of Cardioviva™ Probiotic Supplement Capsule Formulation

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.

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