Efficacy of Cardioviva™ Probiotic Yogurt Formulation

NCT ID: NCT01185795

Last Updated: 2012-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-04-30

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.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cardioviva™ yogurt

Group Type: EXPERIMENTAL

Cardioviva™ yogurt

Intervention Type: DIETARY_SUPPLEMENT

L. reuteri cardioviva in yogurt, twice per day (BID), 6 weeks

Placebo yogurt

Group Type: PLACEBO_COMPARATOR

Placebo yogurt

Intervention Type: DIETARY_SUPPLEMENT

yogurt, twice per day (BID), 6 weeks

Interventions

Cardioviva™ yogurt

L. reuteri cardioviva in yogurt, twice per day (BID), 6 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo yogurt

yogurt, twice per day (BID), 6 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Micropharma Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitchell L Jones, MD, MEng

Role: STUDY_DIRECTOR

Micropharma Limited

Other Identifiers

MP-001

Identifier Type: -

Identifier Source: org_study_id