- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01185795
Efficacy of Cardioviva™ Probiotic Yogurt Formulation
Efficacy of a Microencapsulated Probiotic Yogurt Formulation as a Health Promoting Agent
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cardioviva™ yogurt
|
L. reuteri cardioviva in yogurt, twice per day (BID), 6 weeks
|
PLACEBO_COMPARATOR: Placebo yogurt
|
yogurt, twice per day (BID), 6 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary outcome variable will be the percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C)
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mitchell L Jones, MD, MEng, Micropharma Limited
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MP-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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