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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02734706
Recruitment Status : Completed
First Posted : April 12, 2016
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dietary Supplement: LRC™ capsule Other: Placebo capsule Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of a Supplement Capsule Containing LRC™ (L. Reuteri NCIMB 30242) on Managing Cholesterol Levels in Adults
Study Start Date : March 2016
Actual Primary Completion Date : November 2018
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Serum LDL-cholesterol after 9 weeks of product consumption. [ Time Frame: 9 weeks ]

Secondary Outcome Measures :
  1. Serum LDL-cholesterol after 6 weeks of product consumption. [ Time Frame: 6 weeks ]
  2. Serum total cholesterol after 6 and 9 weeks of product consumption. [ Time Frame: 6 and 9 weeks ]
  3. Serum HDL-cholesterol after 6 and 9 weeks of product consumption. [ Time Frame: 6 and 9 weeks ]
  4. Serum non-HDL-cholesterol after 6 and 9 weeks of product consumption. [ Time Frame: 6 and 9 weeks ]
  5. Serum triglycerides after 6 and 9 weeks of product consumption. [ Time Frame: 6 and 9 weeks ]
  6. Serum apolipoprotein B-100 after 6 and 9 weeks of product consumption. [ Time Frame: 6 and 9 weeks ]
  7. Serum hs-CRP after 9 weeks of product consumption. [ Time Frame: 9 weeks ]
  8. Plasma fibrinogen after 9 weeks of product consumption. [ Time Frame: 9 weeks ]
  9. Plasma homocysteine after 9 weeks of product consumption. [ Time Frame: 9 weeks ]
  10. GI health questionnaire score after 6 and 9 weeks of product consumption. [ Time Frame: 6 and 9 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734706


Locations
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Canada, Ontario
KGK Synergize Inc.
London, Ontario, Canada, N6A 5R8
Sponsors and Collaborators
UAS Labs LLC
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Responsible Party: UAS Labs LLC
ClinicalTrials.gov Identifier: NCT02734706    
Other Study ID Numbers: 15LCHU
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases