Efficacy of Cardioviva™ Probiotic Supplement Capsule Formulation

NCT01341613 | Completed Phase 2

• 1 other identifier: MP-0110
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

Background: It is becoming increasingly clear that individuals from all corners of the globe use probiotic dietary approaches to enhance health. More recently, probiotics have shown promise in treating a variety of disease states, due to improved strain selection, stability and delivery technologies. Objective: The purpose of this study is to determine the lipid lowering efficacy of a probiotic supplement capsule containing Lactobacillus reuteri Cardioviva™, taken twice per day over 9 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 13 weeks, including a 2-week wash-out period, a 2-week run-in period and a 9 week treatment period.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the percent difference in LDL-cholesterol from baseline to endpoint comparing subjects receiving treatment and placebo

  9 weeks

Study Arms (2)

Cardioviva™ supplement capsule

EXPERIMENTAL

Dietary Supplement: Cardioviva™ supplement capsule

Placebo capsule

PLACEBO COMPARATOR

Dietary Supplement: Placebo capsule

Interventions

Cardioviva™ supplement capsule DIETARY_SUPPLEMENT

Twice per day (BID), 9 weeks

Cardioviva™ supplement capsule

Placebo capsule DIETARY_SUPPLEMENT

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 (bounds included)
• LDL-Cholesterol above 3.4 mmol/L (\<15% variation between visits V1 and V2-1)
• TG levels below 4.0 mmol/L (checked at visits V0 and V2-1)
• BMI range will be 22 to 32 kg/m²
• Subject understands and accepts to follow the dietary recommendations advisable for hypercholesterolemic patients (according to NCEP-ATP III guidelines)
• For subjects on statin monotherapy: dosage of statin must be stable for at least 3 months prior to the study beginning (15-20% of all subjects)
• 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
• For female subjects: effective contraceptive methods used

You may not qualify if:

• Use of cholesterol lowering prescription drugs other than statin monotherapy 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 food supplements within last 3 months
• History of chronic use of alcohol (\>2 drinks/d)
• Use of systemic antibodies, corticosteroids, androgens, or phenytoin
• Subject having experienced any cardiovascular event (Myocardial infarction, coronary artery bypass, or other major surgical procedures) in the last 6 months
• Diabetic subject (Type I or Type II)
• 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)
• 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

Sponsors & Collaborators

• Micropharma Limited: lead

Study Sites (1)

APharma s.r.o.

Prague, Czechia

Location

Related Publications (3)

• Jones ML, Martoni CJ, Ganopolsky JG, Sulemankhil I, Ghali P, Prakash S. Improvement of gastrointestinal health status in subjects consuming Lactobacillus reuteri NCIMB 30242 capsules: a post-hoc analysis of a randomized controlled trial. Expert Opin Biol Ther. 2013 Dec;13(12):1643-51. doi: 10.1517/14712598.2013.833601. Epub 2013 Sep 28.

  PMID: 24074303 DERIVED

• Jones ML, Martoni CJ, Prakash S. Letter to the editor regarding the report of Duboc et al: Connecting dysbiosis, bile-acid dysmetabolism and gut inflammation in inflammatory bowel disease. Gut. 2013 Apr;62(4):654-5. doi: 10.1136/gutjnl-2012-303867. Epub 2012 Nov 12. No abstract available.

  PMID: 23148122 DERIVED

• Jones ML, Martoni CJ, Di Pietro E, Simon RR, Prakash S. Evaluation of clinical safety and tolerance of a Lactobacillus reuteri NCIMB 30242 supplement capsule: a randomized control trial. Regul Toxicol Pharmacol. 2012 Jul;63(2):313-20. doi: 10.1016/j.yrtph.2012.04.003. Epub 2012 Apr 25.

  PMID: 22561556 DERIVED

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2011
• First Posted: April 26, 2011
• Study Start: May 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 2, 2011

Record last verified: 2011-11

Locations

CZ (1)