Hypercholesterolemia
Conditions
Brief summary
To investigate the effect of a supplement capsule containing LRC™ (L. reuteri NCIMB 30242), taken twice daily with lunch and dinner (NLT 2.5E9 CFU per dose), versus placebo capsule on serum low density lipoprotein (LDL)-cholesterol in otherwise healthy hypercholesterolemic adults after 9 weeks of product consumption.
Interventions
DIETARY_SUPPLEMENTLRC™ capsule
Twice per day (BID), 9 weeks
OTHERPlacebo capsule
Twice per day (BID), 9 weeks
Sponsors
UAS Labs LLC
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. * LDL-C ≥ 3.40 mmol/L at visits V0 and V2-1 (\<15% variation between visits V0 and V2-1). * TG \< 4.00 mmol/L (checked at visits V0 and V2-1). * BMI between 23.0 to 32.5 kg/m2. * 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. * Subjects taking stable doses of thyroid hormone and anti-hypertensive agents will be permitted, as long as these are continued equivalently throughout the duration of study. * Agreement to maintain current level of physical activity throughout the 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. * Voluntary, written, informed consent to participate in the study.
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 or any other endocrine disorders such as adrenal insufficiency, Cushing's disease, hyperthyroidism, hypopituitarism or polycystic ovary syndrome. * 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). * Diagnosis of anemia or bleeding disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum LDL-cholesterol after 9 weeks of product consumption. | 9 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Serum total cholesterol after 6 and 9 weeks of product consumption. | 6 and 9 weeks |
| Serum HDL-cholesterol after 6 and 9 weeks of product consumption. | 6 and 9 weeks |
| Serum non-HDL-cholesterol after 6 and 9 weeks of product consumption. | 6 and 9 weeks |
| Serum triglycerides after 6 and 9 weeks of product consumption. | 6 and 9 weeks |
| Serum LDL-cholesterol after 6 weeks of product consumption. | 6 weeks |
| Serum hs-CRP after 9 weeks of product consumption. | 9 weeks |
| Plasma fibrinogen after 9 weeks of product consumption. | 9 weeks |
| Plasma homocysteine after 9 weeks of product consumption. | 9 weeks |
| GI health questionnaire score after 6 and 9 weeks of product consumption. | 6 and 9 weeks |
| Serum apolipoprotein B-100 after 6 and 9 weeks of product consumption. | 6 and 9 weeks |
Countries
Canada
Outcome results
None listed