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

Study Overview
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Brief Summary
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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.

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: One-a-Day L. reuteri NCIMB 30242 supplement capsule
* Dietary Supplement: One-a-Day placebo capsule


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One-a-Day L. reuteri NCIMB 30242 supplement capsule<br> | Dietary Supplement: One-a-Day L. reuteri NCIMB 30242 supplement capsule<br>* Once per day, 12 weeks<br>|
| Placebo Comparator: One-a-Day placebo capsule<br> | Dietary Supplement: One-a-Day placebo capsule<br>* Once per day, 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |