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CompletedNCT01185795Updated Jul 2, 2012

Efficacy of Cardioviva™ Probiotic Yogurt Formulation

A Phase 2 interventional study of Cardioviva™ yogurt and Placebo yogurt in Hypercholesterolemia, sponsored by Micropharma Limited. Completed. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2012-07-02.

Sponsored by Micropharma Limited · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 74 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypercholesterolemia

Keywords

  • yogurt
  • probiotic
  • cholesterol
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 110 are open to participants now.

This study's enrollment of 150 is above the median of 100 across 992 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Micropharma Limited is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Cardioviva™ yogurt

    Dietary Supplement: Cardioviva™ yogurt

  • Placebo comparator
    Placebo yogurt

    Dietary Supplement: Placebo yogurt

Interventions

  • Dietary supplementCardioviva™ yogurt

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

  • Dietary supplementPlacebo yogurt

    yogurt, twice per day (BID), 6 weeks

06

What researchers measure

Primary outcomes

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

    Time frame: 6 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01185795
Lead sponsor
Micropharma Limited
Responsible party
Sponsor
First posted
Aug 20, 2010
Start date
Sep 2008
Primary completion
Jan 2009
Completion
Apr 2009
Last update
Jul 2, 2012

Study contacts

Mitchell L Jones, MD, MEng
study director · Micropharma Limited

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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