Efficacy of a LRC™ (L. Reuteri NCIMB 30242) Capsule on Managing Cholesterol in Adults
Not Applicable
Completed
- Conditions
- Hypercholesterolemia
- Interventions
- Dietary Supplement: LRC™ capsuleOther: Placebo capsule
- Registration Number
- NCT02734706
- Lead Sponsor
- UAS Labs LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 111
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LRC™ capsule LRC™ capsule - Placebo capsule Placebo capsule -
- Primary Outcome Measures
Name Time Method Serum LDL-cholesterol after 9 weeks of product consumption. 9 weeks
- Secondary Outcome Measures
Name Time Method Serum total cholesterol after 6 and 9 weeks of product consumption. 6 and 9 weeks Serum LDL-cholesterol after 6 weeks of product consumption. 6 weeks Serum HDL-cholesterol after 6 and 9 weeks of product consumption. 6 and 9 weeks Plasma fibrinogen after 9 weeks of product consumption. 9 weeks Plasma homocysteine after 9 weeks of product consumption. 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 non-HDL-cholesterol after 6 and 9 weeks of product consumption. 6 and 9 weeks Serum hs-CRP after 9 weeks of product consumption. 9 weeks GI health questionnaire score after 6 and 9 weeks of product consumption. 6 and 9 weeks
Trial Locations
- Locations (1)
KGK Synergize Inc.
🇨🇦London, Ontario, Canada