Clinical trial NCT01185795: Efficacy of Cardioviva™ Probiotic Yogurt Formulation
Official title: Efficacy of a Microencapsulated Probiotic Yogurt Formulation as a Health Promoting Agent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Keywords: yogurt
probiotic
cholesterol
Lead sponsor: Micropharma Limited
Sponsor class: INDUSTRY
First posted: 2010-08-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The primary outcome variable will be the percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Micropharma Limited
name: Mitchell L Jones, MD, MEng
role: STUDY_DIRECTOR
References: