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 bile salt hydrolase active Lactobacillus reuteri NCIMB 30242 in improving the lipid profile in hypercholesterolemic adults. Objective: The purpose of the study is to investigate the effect of a delayed release or standard vegetarian capsule containing L. reuteri NCIMB 30242, taken in escalated dose over a 4 week period, on the plasma bile acid profile. Design: The study design is a pilot, randomized, double-blind, dose-escalation study. The study will last a total of 6 weeks, including a 4-week intervention period and a 2-week washout period.
Interventions
DIETARY_SUPPLEMENTDelayed release capsule, L. reuteri NCIMB 30242, escalated dose
DIETARY_SUPPLEMENTStandard vegetarian capsule, L. reuteri NCIMB 30242, escalated dose
Sponsors
Micropharma Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Inclusion criteria
* Males and females, aged 20 to 75 years (bounds included). * LDL-C ≥ 3.40 mmol/L. * TG \< 4.00 mmol/L. * TBA \< 10 umol/L. * BMI range from 23.0 to 32.5 kg/m2 (bounds included). * 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. * Female subjects 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 who 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. * Female subjects that are pregnant, breast feeding or intend 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 plasma bile acid profile from baseline to endpoint | Week 0 and Week 4 of intervention period |
Outcome results
None listed