Efficacy of a LRC™ (L. Reuteri NCIMB 30242) Capsule on Managing Cholesterol in Adults

May 8, 2019 updated by: UAS Labs LLC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
111

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5R8
        • KGK Synergize Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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).
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LRC™ capsule
Dietary supplement: LRC™ capsule
Twice per day (BID), 9 weeks
Placebo Comparator: Placebo capsule
Other: Placebo capsule
Twice per day (BID), 9 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Serum LDL-cholesterol after 9 weeks of product consumption.
Time Frame: 9 weeks
9 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Serum LDL-cholesterol after 6 weeks of product consumption.
Time Frame: 6 weeks
6 weeks
Serum total cholesterol after 6 and 9 weeks of product consumption.
Time Frame: 6 and 9 weeks
6 and 9 weeks
Serum HDL-cholesterol after 6 and 9 weeks of product consumption.
Time Frame: 6 and 9 weeks
6 and 9 weeks
Serum non-HDL-cholesterol after 6 and 9 weeks of product consumption.
Time Frame: 6 and 9 weeks
6 and 9 weeks
Serum triglycerides after 6 and 9 weeks of product consumption.
Time Frame: 6 and 9 weeks
6 and 9 weeks
Serum apolipoprotein B-100 after 6 and 9 weeks of product consumption.
Time Frame: 6 and 9 weeks
6 and 9 weeks
Serum hs-CRP after 9 weeks of product consumption.
Time Frame: 9 weeks
9 weeks
Plasma fibrinogen after 9 weeks of product consumption.
Time Frame: 9 weeks
9 weeks
Plasma homocysteine after 9 weeks of product consumption.
Time Frame: 9 weeks
9 weeks
GI health questionnaire score after 6 and 9 weeks of product consumption.
Time Frame: 6 and 9 weeks
6 and 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UAS Labs LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15LCHU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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