HypercholesterolemiaNCT02734706
Efficacy of a LRC™ (L. Reuteri NCIMB 30242) Capsule on Managing Cholesterol in Adults
A study testing LRC™ capsule in people with Hypercholesterolemia, run by UAS Labs LLC at 1 site in Canada.
Trial summary
To investigate the effect of a supplement capsule containing LRC™ (L. reuteri NCIMB 30242), taken twice daily with lunch and dinner (NLT 2.5E9 CFU per dose), versus placebo capsule on serum low density lipoprotein (LDL)-cholesterol in otherwise healthy hypercholesterolemic adults after 9 weeks of product consumption. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- LRC™ capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to Feb 2019
- Phase
- Interventional
- 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.
- LDL-C ≥ 3.40 mmol/L at visits V0 and V2-1 (<15% variation between visits V0 and V2-1).
- TG < 4.00 mmol/L (checked at visits V0 and V2-1).
- BMI between 23.0 to 32.5 kg/m2.
- 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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- Subjects taking stable doses of thyroid hormone and anti-hypertensive agents will be permitted, as long as these are continued equivalently throughout the duration of study.
- Agreement to maintain current level of physical activity throughout the 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.
- Voluntary, written, informed consent to participate in the study.
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 or any other endocrine disorders such as adrenal insufficiency, Cushing's disease, hyperthyroidism, hypopituitarism or polycystic ovary syndrome.
- 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).
- Diagnosis of anemia or bleeding disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Supplement Capsule Containing LRC™ (L. Reuteri NCIMB 30242) on Managing Cholesterol Levels in Adults
To investigate the effect of a supplement capsule containing LRC™ (L. reuteri NCIMB 30242), taken twice daily with lunch and dinner (NLT 2.5E9 CFU per dose), versus placebo capsule on serum low density lipoprotein (LDL)-cholesterol in otherwise healthy hypercholesterolemic adults after 9 weeks of product consumption.
- Conditions
- Hypercholesterolemia
- Being tested
- LRC™ capsule, 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.
LRC™ capsuleDietary supplement
Twice per day (BID), 9 weeks
Placebo capsuleOther
Twice per day (BID), 9 weeks
| Study group | Role | What they receive |
|---|---|---|
| LRC™ capsule | Experimental | Not described Receives: Dietary Supplement: LRC™ capsule |
| Placebo capsule | Placebo comparator | Not described Receives: Other: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum LDL-cholesterol after 9 weeks of product consumption.
Measured: 9 weeks
Secondary outcomes (10)
Serum LDL-cholesterol after 6 weeks of product consumption.
Measured: 6 weeks
Serum total cholesterol after 6 and 9 weeks of product consumption.
Measured: 6 and 9 weeks
Serum HDL-cholesterol after 6 and 9 weeks of product consumption.
Measured: 6 and 9 weeks
Serum non-HDL-cholesterol after 6 and 9 weeks of product consumption.
Measured: 6 and 9 weeks
Serum triglycerides after 6 and 9 weeks of product consumption.
Measured: 6 and 9 weeks
Serum apolipoprotein B-100 after 6 and 9 weeks of product consumption.
Measured: 6 and 9 weeks
Serum hs-CRP after 9 weeks of product consumption.
Measured: 9 weeks
Plasma fibrinogen after 9 weeks of product consumption.
Measured: 9 weeks
Plasma homocysteine after 9 weeks of product consumption.
Measured: 9 weeks
GI health questionnaire score after 6 and 9 weeks of product consumption.
Measured: 6 and 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionNov 2018
- Study completionFeb 2019
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- UAS Labs LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734706
- Sponsor's protocol ID
- 15LCHU
- Status last verified
- May 2019
- First submitted
- 23 Mar 2016
- Last updated
- 10 May 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Supplement Capsule Containing LRC™ (L. Reuteri NCIMB 30242) on Managing Cholesterol Levels in Adults
- ClinicalTrials.gov ID
- NCT02734706
- Acronym / sponsor ID
- 15LCHU
- Conditions
- Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- UAS Labs LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Nov 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 12 Apr 2016 (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.
To investigate the effect of a supplement capsule containing LRC™ (L. reuteri NCIMB 30242), taken twice daily with lunch and dinner (NLT 2.5E9 CFU per dose), versus placebo capsule on serum low density lipoprotein (LDL)-cholesterol in otherwise healthy hypercholesterolemic adults after 9 weeks of product consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LRC™ capsule | Experimental | Dietary Supplement: LRC™ capsule |
| Placebo capsule | Placebo comparator | Other: Placebo capsule |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and females aged 20 to 75 years.
- LDL-C ≥ 3.40 mmol/L at visits V0 and V2-1 (<15% variation between visits V0 and V2-1).
- TG < 4.00 mmol/L (checked at visits V0 and V2-1).
- BMI between 23.0 to 32.5 kg/m2.
- Subject understands and accepts to follow the dietary recommendations advisable for hypercholesterolemic patients (according to NCEP-ATP III guidelines)
Key exclusion criteria (20 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 |
|---|---|---|
| LRC™ capsuleTwice per day (BID), 9 weeks | Dietary supplement | LRC™ capsule |
| Placebo capsuleTwice per day (BID), 9 weeks | Other | Placebo capsule |
Primary outcome
Serum LDL-cholesterol after 9 weeks of product consumption.
Time frame: 9 weeks
10 secondary outcomes
Serum LDL-cholesterol after 6 weeks of product consumption.
Time frame: 6 weeks
Serum total cholesterol after 6 and 9 weeks of product consumption.
Time frame: 6 and 9 weeks
Serum HDL-cholesterol after 6 and 9 weeks of product consumption.
Time frame: 6 and 9 weeks
Serum non-HDL-cholesterol after 6 and 9 weeks of product consumption.
Time frame: 6 and 9 weeks
Serum triglycerides after 6 and 9 weeks of product consumption.
Time frame: 6 and 9 weeks
Serum apolipoprotein B-100 after 6 and 9 weeks of product consumption.
Time frame: 6 and 9 weeks
Serum hs-CRP after 9 weeks of product consumption.
Time frame: 9 weeks
Plasma fibrinogen after 9 weeks of product consumption.
Time frame: 9 weeks
Plasma homocysteine after 9 weeks of product consumption.
Time frame: 9 weeks
GI health questionnaire score after 6 and 9 weeks of product consumption.
Time frame: 6 and 9 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 10 May 2019.
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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 study testing LRC™ capsule in people with Hypercholesterolemia, run by UAS Labs LLC 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 10 inclusion and 20 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 10 May 2019. 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.
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?
Serum LDL-cholesterol after 9 weeks of product consumption. (time frame: 9 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 10 May 2019.