efficacy of a one-a-day l. reuteri ncimb 30242 probiotic supplement capsule

Conditions: Hypercholesterolemia

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.


Eligibility 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).