HypercholesterolemiaPhase 2NCT01630668
Efficacy of a One-a-Day L. Reuteri NCIMB 30242 Probiotic Supplement Capsule
A Phase 2 study testing One-a-Day L. reuteri NCIMB 30242 supplement capsule in people with Hypercholesterolemia, run by Micropharma Limited at 1 site in Canada.
Trial summary
Background: In recent years, probiotics have shown promise in treating a variety of diseases. Previously, the investigators have reported on the clinical efficacy of Lactobacillus reuteri NCIMB 30242 in improving the lipid profile in hypercholesterolemic adults. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- One-a-Day L. reuteri NCIMB 30242 supplement capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2012to Jun 2014
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, aged 20 to 75 years (bounds included).
- LDL-C ≥ 3.40 mmol/L (<15% variation between visits V0 and V2-1).
- TG < 4.00 mmol/L (confirmed at visits V0 and V2-1).
- BMI range will be 23.0 to 32.5 kg/m2 (bounds included).
- Subject understands and accepts to follow the dietary recommendations advisable for hypercholesterolemic patients (according to NCEP-ATP III guidelines).
- Judged by the investigators as compliant (>80%) with product consumption (check at V2-1), and motivated.
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- Signed informed consent form prior to inclusion in the study.
- Note: Subjects will be permitted to take stable doses of thyroid hormone and anti-hypertensive agents, as long as these are continued equivalently throughout the duration of study.
- If female, subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation). OR Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Intrauterine devices
- Vasectomy of partner
- Total abstinence
Who cannot join
- Use of 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 1 month.
- History of chronic use of alcohol (> 2 drinks/d).
- History of heavy smoking (≥ 20 cigarettes/d).
- Use of systemic antibodies, corticosteroids, androgens, or phenytoin.
- Immune-compromised subjects (e.g. AIDS, lymphoma, subjects undergoing long-term corticosteroid treatment)
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- Subject having experienced any cardiovascular event (Myocardial infarction, coronary artery bypass, or other major surgical procedures) in the last 6 months.
- Subjects with elevated LDL-C (≥ 3.40 mmol/L) and high (>20%) CVD risk estimated by the Framingham risk score.
- Previously diagnosed Type I or Type II diabetes.
- Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters.
- Subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial.
- History of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year).
- Clinically significant abnormal laboratory results at screening.
- Chronic user of probiotics or fibre laxative (greater than 2 doses/wk), or stimulant laxatives.
- History of eating disorders.
- Exercise greater than 15 miles/wk or 4,000 kcal/wk.
- For female subjects: Pregnancy, breast feeding, or intent to get pregnant.
- Allergy or sensitivity to test product ingredients
- Allergy or sensitivity to all 3 antibiotics (Clindamycin, Erythromycin and Ampicillin).
Trial locations and contacts
1 site in 1 country.
About this study
Background: In recent years, probiotics have shown promise in treating a variety of diseases. Previously, the investigators have reported on the clinical efficacy of Lactobacillus reuteri NCIMB 30242 in improving the lipid profile in hypercholesterolemic adults.
Objective: The purpose of the study is to determine the lipid lowering efficacy of a One-a-Day probiotic supplement capsule containing Lactobacillus reuteri NCIMB 30242 over 12 weeks in subjects with hypercholesterolemia.
Design: The study design is a double-blinded, placebo-controlled, randomized, parallel-arm, multi-centre study. The study will last a total of 14 weeks, including a 2-week run-in period and a 12-week intervention period.
- Conditions
- Hypercholesterolemia
- Being tested
- One-a-Day L. reuteri NCIMB 30242 supplement capsule, One-a-Day placebo capsule
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-a-Day L. reuteri NCIMB 30242 supplement capsuleDietary supplement
Once per day, 12 weeks
One-a-Day placebo capsuleDietary supplement
Once per day, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| One-a-Day L. reuteri NCIMB 30242 supplement capsule | Experimental | Not described Receives: Dietary Supplement: One-a-Day L. reuteri NCIMB 30242 supplement capsule |
| One-a-Day placebo capsule | Placebo comparator | Not described Receives: Dietary Supplement: One-a-Day placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the change in serum LDL-cholesterol from baseline to endpoint between control and treatment groups.
Measured: Week 0 and Week 12 of intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2013
- Study completionJun 2014
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Micropharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630668
- Sponsor's protocol ID
- MP-12LCHM
- Status last verified
- Jun 2014
- First submitted
- 26 Jun 2012
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a One-a-Day L. Reuteri NCIMB 30242 Probiotic Supplement Capsule
- ClinicalTrials.gov ID
- NCT01630668
- Acronym / sponsor ID
- MP-12LCHM
- Conditions
- Hypercholesterolemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Micropharma LimitedIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 28 Jun 2012 (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: In recent years, probiotics have shown promise in treating a variety of diseases. Previously, the investigators have reported on the clinical efficacy of Lactobacillus reuteri NCIMB 30242 in improving the lipid profile in hypercholesterolemic adults.
Objective: The purpose of the study is to determine the lipid lowering efficacy of a One-a-Day probiotic supplement capsule containing Lactobacillus reuteri NCIMB 30242 over 12 weeks in subjects with hypercholesterolemia.
Design: The study design is a double-blinded, placebo-controlled, randomized, parallel-arm, multi-centre study. The study will last a total of 14 weeks, including a 2-week run-in period and a 12-week intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-a-Day L. reuteri NCIMB 30242 supplement capsule | Experimental | Dietary Supplement: One-a-Day L. reuteri NCIMB 30242 supplement capsule |
| One-a-Day placebo capsule | Placebo comparator | Dietary Supplement: One-a-Day placebo capsule |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Males and females, aged 20 to 75 years (bounds included).
- LDL-C ≥ 3.40 mmol/L (<15% variation between visits V0 and V2-1).
- TG < 4.00 mmol/L (confirmed at visits V0 and V2-1).
- BMI range will be 23.0 to 32.5 kg/m2 (bounds included).
- Subject understands and accepts to follow the dietary recommendations advisable for hypercholesterolemic patients (according to NCEP-ATP III guidelines).
Key exclusion criteria (19 listed)
- Use of 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 1 month.
- History of chronic use of alcohol (> 2 drinks/d).
- History of heavy smoking (≥ 20 cigarettes/d).
- Use of systemic antibodies, corticosteroids, androgens, or phenytoin.
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 |
|---|---|---|
| One-a-Day L. reuteri NCIMB 30242 supplement capsuleOnce per day, 12 weeks | Dietary supplement | One-a-Day L. reuteri NCIMB 30242 supplement capsule |
| One-a-Day placebo capsuleOnce per day, 12 weeks | Dietary supplement | One-a-Day placebo capsule |
Primary outcome
The primary outcome will be the change in serum LDL-cholesterol from baseline to endpoint between control and treatment groups.
Time frame: Week 0 and Week 12 of intervention period
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 26 Jun 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing One-a-Day L. reuteri NCIMB 30242 supplement capsule in people with Hypercholesterolemia, run by Micropharma Limited at 1 site in Canada.
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 13 inclusion and 19 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 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 will be the change in serum LDL-cholesterol from baseline to endpoint between control and treatment groups. (time frame: Week 0 and Week 12 of intervention period). 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 26 Jun 2014.