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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02734706
• Other study ID #: 15LCHU
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: February 2019

Study information

• Verified date: May 2019
• Source: UAS Labs LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: February 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• LRC™ capsule
Twice per day (BID), 9 weeks

Other:
• Placebo capsule
Twice per day (BID), 9 weeks

Locations

Country	Name	City	State
Canada	KGK Synergize Inc.	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
UAS Labs LLC

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum LDL-cholesterol after 9 weeks of product consumption.		9 weeks
Secondary	Serum LDL-cholesterol after 6 weeks of product consumption.		6 weeks
Secondary	Serum total cholesterol after 6 and 9 weeks of product consumption.		6 and 9 weeks
Secondary	Serum HDL-cholesterol after 6 and 9 weeks of product consumption.		6 and 9 weeks
Secondary	Serum non-HDL-cholesterol after 6 and 9 weeks of product consumption.		6 and 9 weeks
Secondary	Serum triglycerides after 6 and 9 weeks of product consumption.		6 and 9 weeks
Secondary	Serum apolipoprotein B-100 after 6 and 9 weeks of product consumption.		6 and 9 weeks
Secondary	Serum hs-CRP after 9 weeks of product consumption.		9 weeks
Secondary	Plasma fibrinogen after 9 weeks of product consumption.		9 weeks
Secondary	Plasma homocysteine after 9 weeks of product consumption.		9 weeks
Secondary	GI health questionnaire score after 6 and 9 weeks of product consumption.		6 and 9 weeks