Efficacy of Cardioviva™ Probiotic Yogurt Formulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Micropharma Limited
ClinicalTrials.gov Identifier:
NCT01185795
First received: August 18, 2010
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Hypercholesterolemia
Dietary Supplement: Cardioviva™ yogurt
Dietary Supplement: Placebo yogurt
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Microencapsulated Probiotic Yogurt Formulation as a Health Promoting Agent

Resource links provided by NLM:


Further study details as provided by Micropharma Limited:

Primary Outcome Measures:
  • The primary outcome variable will be the percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: September 2008
Study Completion Date: April 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01185795

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

No publications provided

Responsible Party: Micropharma Limited
ClinicalTrials.gov Identifier: NCT01185795     History of Changes
Other Study ID Numbers: MP-001
Study First Received: August 18, 2010
Last Updated: June 29, 2012
Health Authority: Czech Republic: Ethics Committee

Keywords provided by Micropharma Limited:
yogurt
probiotic
cholesterol

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 22, 2014