Efficacy of Cardioviva™ Probiotic Yogurt Formulation

Micropharma

Status and phase

Completed

Phase 2

Conditions

Hypercholesterolemia

Treatments

Dietary Supplement: Cardioviva™ yogurt

Dietary Supplement: Placebo yogurt

Study type

Interventional

Funder types

Industry

Identifiers

NCT01185795

MP-001

Details and patient eligibility

About

Background: Several studies have reported limited or no reduction in serum lipid concentrations in response to probiotic formulations. More recently, probiotics have shown promise in treating metabolic disease, due to improved strain selection and delivery technologies.

Objective: To evaluate the lipid lowering efficacy of a yogurt formulation containing microencapsulated Bile Salt Hydrolase (BSH)-active Lactobacillus reuteri cardioviva, taken twice per day over 6 weeks, in subjects with hypercholesterolemia.

Design: This is a double-blinded, multi-centric, placebo-controlled, randomized, parallel-arm study. The study will last a total of 10 weeks including 2-week wash-out, 2-week run-in, and 6- week treatment period.

Enrollment

150 patients

Sex

All

Ages

18 to 74 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Healthy males and females.
Aged 18-74 years old.
Low Density Lipoprotein (LDL-C) above 3.4 mmol/L (<15% variation between visits V1 and V2-1).
Triglyceride (TG) levels below 4.0 mmol/l (check at V0 and V2-1).
Body Mass Index (BMI) range was 22 to 32 kg/m2.
Ability to understand dietary procedures.
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 were permitted to take stable doses of thyroid hormone, anti-hypertensive agents, and contraceptive hormones (e.g. contraceptive pills or patches), as long as these were continued equivalently throughout the duration of study.

Exclusion criteria

Use of statin or other cholesterol lowering prescription drugs 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 supplements within last 3 months.
History of chronic use of alcohol (>2 drinks/day).
Use of systemic antibodies, corticosteroids, androgens, or phenytoin.
Myocardial infarction, coronary artery bypass, or other major surgical procedures within the last six months.
Lactose intolerance or allergies to dairy products.
History of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, 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 fiber laxative (greater than 2 doses/week), or stimulant laxatives.
History of eating disorders.
Exercise greater than 15 miles/week or 4,000 kcal/week.
Pregnancy, breast feeding, or intent to get pregnant.