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

Hypercholesterolemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01630668
• Other study ID #: MP-12LCHM
• Status: Completed
• Phase: Phase 2
• First received: June 26, 2012
• Last updated: June 25, 2014
• Start date: August 2012
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Micropharma Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• One-a-Day L. reuteri NCIMB 30242 supplement capsule
Once per day, 12 weeks
• One-a-Day placebo capsule
Once per day, 12 weeks

Locations

Country	Name	City	State
Canada	KGK Synergize Inc.	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Micropharma Limited

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be the change in serum LDL-cholesterol from baseline to endpoint between control and treatment groups.		Week 0 and Week 12 of intervention period	No