Efficacy of a LRC™ (L. Reuteri NCIMB 30242) Capsule on Managing Cholesterol in Adults

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of a Supplement Capsule Containing LRC™ (L. Reuteri NCIMB 30242) on Managing Cholesterol Levels in Adults

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: LRC™ capsule
* Other: Placebo capsule


Participation Criteria
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Eligibility Criteria
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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

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: LRC™ capsule<br> | Dietary Supplement: LRC™ capsule<br>* Twice per day (BID), 9 weeks<br>|
| Placebo Comparator: Placebo capsule<br> | Other: Placebo capsule<br>* Twice per day (BID), 9 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum LDL-cholesterol after 9 weeks of product consumption. |  | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum LDL-cholesterol after 6 weeks of product consumption. |  | 6 weeks | 
| 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 apolipoprotein B-100 after 6 and 9 weeks of product consumption. |  | 6 and 9 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 |