Efficacy of a One-a-Day L. Reuteri NCIMB 30242 Probiotic Supplement Capsule

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Micropharma Limited
ClinicalTrials.gov Identifier:
NCT01630668
First received: June 26, 2012
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Hypercholesterolemia
Dietary Supplement: One-a-Day L. reuteri NCIMB 30242 supplement capsule
Dietary Supplement: One-a-Day placebo capsule
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Micropharma Limited:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: August 2012
Estimated Study Completion Date: February 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: One-a-Day L. reuteri NCIMB 30242 supplement capsule Dietary Supplement: One-a-Day L. reuteri NCIMB 30242 supplement capsule
Once per day, 12 weeks
Placebo Comparator: One-a-Day placebo capsule Dietary Supplement: One-a-Day placebo capsule
Once per day, 12 weeks

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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.
  • 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

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.
  • 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630668

Locations
Canada, Ontario
KGK Synergize Inc.
London, Ontario, Canada, N6A 5R8
Sponsors and Collaborators
Micropharma Limited
  More Information

No publications provided

Responsible Party: Micropharma Limited
ClinicalTrials.gov Identifier: NCT01630668     History of Changes
Other Study ID Numbers: MP-12LCHM
Study First Received: June 26, 2012
Last Updated: November 18, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 14, 2014