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

• ClinicalTrials.gov Identifier: NCT01630668
• Recruitment Status: Completed
• First Posted: June 28, 2012
• Last Update Posted: June 26, 2014
• Sponsor: Micropharma Limited
• Information provided by (Responsible Party): Micropharma Limited

Study Description

Brief 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.

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 or disease	Intervention/treatment	Phase
Hypercholesterolemia	Dietary Supplement: One-a-Day L. reuteri NCIMB 30242 supplement capsule; Dietary Supplement: One-a-Day placebo capsule	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: August 2012
• Actual Primary Completion Date: December 2013
• Actual Study Completion Date: June 2014

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Canada, Ontario

KGK Synergize Inc.

London, Ontario, Canada, N6A 5R8

Sponsors and Collaborators

Micropharma Limited

More Information

• Responsible Party: Micropharma Limited
• ClinicalTrials.gov Identifier: NCT01630668
• Other Study ID Numbers: MP-12LCHM
• First Posted: June 28, 2012
• Last Update Posted: June 26, 2014
• Last Verified: June 2014

Additional relevant MeSH terms:

Hypercholesterolemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases