Efficacy of a One-a-Day L. Reuteri NCIMB 30242 Probiotic Supplement Capsule

NCT01630668 | Completed Phase 2

• 1 other identifier: MP-12LCHM
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Background: In recent years, probiotics have shown promise in treating a variety of diseases. Previously, the investigators have reported on the clinical efficacy of Lactobacillus reuteri NCIMB 30242 in improving the lipid profile in hypercholesterolemic adults. Objective: The purpose of the study is to determine the lipid lowering efficacy of a One-a-Day probiotic supplement capsule containing Lactobacillus reuteri NCIMB 30242 over 12 weeks in subjects with hypercholesterolemia. Design: The study design is a double-blinded, placebo-controlled, randomized, parallel-arm, multi-centre study. The study will last a total of 14 weeks, including a 2-week run-in period and a 12-week intervention period.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the change in serum LDL-cholesterol from baseline to endpoint between control and treatment groups.

  Week 0 and Week 12 of intervention period

Study Arms (2)

One-a-Day L. reuteri NCIMB 30242 supplement capsule

EXPERIMENTAL

Dietary Supplement: One-a-Day L. reuteri NCIMB 30242 supplement capsule

One-a-Day placebo capsule

PLACEBO COMPARATOR

Dietary Supplement: One-a-Day placebo capsule

Interventions

One-a-Day L. reuteri NCIMB 30242 supplement capsule DIETARY_SUPPLEMENT

Once per day, 12 weeks

One-a-Day L. reuteri NCIMB 30242 supplement capsule

One-a-Day placebo capsule DIETARY_SUPPLEMENT

Once per day, 12 weeks

One-a-Day 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 (bounds included).
• LDL-C ≥ 3.40 mmol/L (\<15% variation between visits V0 and V2-1).
• TG \< 4.00 mmol/L (confirmed at visits V0 and V2-1).
• BMI range will be 23.0 to 32.5 kg/m2 (bounds included).
• 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.
• Note: Subjects will be permitted to take stable doses of thyroid hormone and anti-hypertensive agents, as long as these are continued equivalently throughout the duration of 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
• Total abstinence

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.
• 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

• Micropharma Limited: 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: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: June 28, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: June 26, 2014

Record last verified: 2014-06

Locations

CA (1)