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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Micropharma Limited
ClinicalTrials.gov Identifier:
NCT01630668
First received: June 26, 2012
Last updated: June 25, 2014
Last verified: June 2014
  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
Study Completion Date: June 2014
Primary Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 25, 2014
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on November 20, 2014