Hypercholesterolemia
Conditions
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.
Interventions
DIETARY_SUPPLEMENTOne-a-Day L. reuteri NCIMB 30242 supplement capsule
Once per day, 12 weeks
DIETARY_SUPPLEMENTOne-a-Day placebo capsule
Once per day, 12 weeks
Sponsors
Micropharma Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | 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 |
Countries
Canada
Outcome results
None listed