Efficacy of Cardioviva™ Probiotic Yogurt Formulation

Phase 2

Completed

• Conditions: Hypercholesterolemia
• Interventions: Dietary Supplement: Cardioviva™ yogurt; Dietary Supplement: Placebo yogurt

• Registration Number: NCT01185795
• Lead Sponsor: Micropharma Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2009-01
• Study Completion: 2009-04
• Study First Submitted: 2010-08-18
• Study First Submitted QC: 2010-08-19
• Study First Posted: 2010-08-20
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-29
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardioviva™ yogurt	Cardioviva™ yogurt	-
Placebo yogurt	Placebo yogurt	-

Primary Outcome Measures

Name	Time	Method
The primary outcome variable will be the percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C)	6 weeks