Efficacy of Cardioviva™ Probiotic Yogurt Formulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01185795
Recruitment Status : Completed
First Posted : August 20, 2010
Last Update Posted : July 2, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dietary Supplement: Cardioviva™ yogurt Dietary Supplement: Placebo yogurt Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Microencapsulated Probiotic Yogurt Formulation as a Health Promoting Agent
Study Start Date : September 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cardioviva™ yogurt Dietary Supplement: Cardioviva™ yogurt
L. reuteri cardioviva in yogurt, twice per day (BID), 6 weeks
Placebo Comparator: Placebo yogurt Dietary Supplement: Placebo yogurt
yogurt, twice per day (BID), 6 weeks

Primary Outcome Measures :
  1. The primary outcome variable will be the percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01185795

Sponsors and Collaborators
Micropharma Limited
Study Director: Mitchell L Jones, MD, MEng Micropharma Limited

Responsible Party: Micropharma Limited Identifier: NCT01185795     History of Changes
Other Study ID Numbers: MP-001
First Posted: August 20, 2010    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: June 2012

Keywords provided by Micropharma Limited:

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases