HypercholesterolemiaPhase 2NCT01185795
Efficacy of Cardioviva™ Probiotic Yogurt Formulation
A Phase 2 study testing Cardioviva™ yogurt in people with Hypercholesterolemia, run by Micropharma Limited.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Cardioviva™ yogurt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Apr 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: 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.
- Conditions
- Hypercholesterolemia
- Being tested
- Cardioviva™ yogurt, Placebo yogurt
- Keywords
- yogurt, probiotic, cholesterol
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardioviva™ yogurtDietary supplement
- reuteri cardioviva in yogurt, twice per day (BID), 6 weeks
Placebo yogurtDietary supplement
yogurt, twice per day (BID), 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cardioviva™ yogurt | Experimental | Not described Receives: Dietary Supplement: Cardioviva™ yogurt |
| Placebo yogurt | Placebo comparator | Not described Receives: Dietary Supplement: Placebo yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome variable will be the percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startSep 2008
- Primary completionJan 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Micropharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitchell L Jones, MD, MEng, Study director, Micropharma Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185795
- Sponsor's protocol ID
- MP-001
- Status last verified
- Jun 2012
- First submitted
- 18 Aug 2010
- Last updated
- 2 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Microencapsulated Probiotic Yogurt Formulation as a Health Promoting Agent
- ClinicalTrials.gov ID
- NCT01185795
- Acronym / sponsor ID
- MP-001
- Conditions
- Hypercholesterolemia
- Keywords
- yogurt, probiotic, cholesterol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Micropharma LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 20 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardioviva™ yogurt | Experimental | Dietary Supplement: Cardioviva™ yogurt |
| Placebo yogurt | Placebo comparator | Dietary Supplement: Placebo yogurt |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardioviva™ yogurtL. reuteri cardioviva in yogurt, twice per day (BID), 6 weeks | Dietary supplement | Cardioviva™ yogurt |
| Placebo yogurtyogurt, twice per day (BID), 6 weeks | Dietary supplement | Placebo yogurt |
Primary outcome
The primary outcome variable will be the percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell L Jones, MD, MEng study director
Micropharma Limited
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cardioviva™ yogurt in people with Hypercholesterolemia, run by Micropharma Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome variable will be the percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2012.