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

NCT02734706 | Completed

• 1 other identifier: 15LCHU
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Serum LDL-cholesterol after 9 weeks of product consumption.

  9 weeks

Secondary Outcomes (10)

• 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

Study Arms (2)

LRC™ capsule

EXPERIMENTAL

Dietary Supplement: LRC™ capsule

Placebo capsule

PLACEBO COMPARATOR

Other: Placebo capsule

Interventions

LRC™ capsule DIETARY_SUPPLEMENT

Twice per day (BID), 9 weeks

LRC™ capsule

Placebo capsule OTHER

Twice per day (BID), 9 weeks

Placebo capsule

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• UAS Labs LLC: lead

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: April 12, 2016
• Study Start: March 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: February 1, 2019
• Last Updated: May 10, 2019

Record last verified: 2019-05

Locations

CA (1)