Efficacy of Cardioviva™ Probiotic Yogurt Formulation

NCT01185795 | Completed Phase 2

• 1 other identifier: MP-001
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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

Keywords

yogurt; probiotic; cholesterol

Outcome Measures

Primary Outcomes (1)

• The primary outcome variable will be the percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C)

  6 weeks

Study Arms (2)

Cardioviva™ yogurt

EXPERIMENTAL

Dietary Supplement: Cardioviva™ yogurt

Placebo yogurt

PLACEBO COMPARATOR

Dietary Supplement: Placebo yogurt

Interventions

Cardioviva™ yogurt DIETARY_SUPPLEMENT

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

Cardioviva™ yogurt

Placebo yogurt DIETARY_SUPPLEMENT

yogurt, twice per day (BID), 6 weeks

Placebo yogurt

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Micropharma Limited: lead

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mitchell L Jones, MD, MEng

  Micropharma Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2010
• First Posted: August 20, 2010
• Study Start: September 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: April 1, 2009
• Last Updated: July 2, 2012

Record last verified: 2012-06