Efficacy of Cardioviva™ Probiotic Supplement Capsule Formulation

Micropharma

Status and phase

Completed

Phase 2

Conditions

Hypercholesterolemia

Treatments

Dietary Supplement: Cardioviva™ supplement capsule

Dietary Supplement: Placebo capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT01341613

MP-0110

Details and patient eligibility

About

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.

Enrollment

131 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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