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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Dietary supplement: LRC™ capsule; Other: Placebo capsule

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5R8
      • KGK Synergize Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LRC™ capsule	Dietary supplement: LRC™ capsule; Twice per day (BID), 9 weeks
Placebo Comparator: Placebo capsule	Other: Placebo capsule; Twice per day (BID), 9 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: UAS Labs LLC

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: April 5, 2016
• First Posted (Estimate): April 12, 2016

Study Record Updates

• Last Update Posted (Actual): May 10, 2019
• Last Update Submitted That Met QC Criteria: May 8, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: 15LCHU