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Efficacy of Cardioviva™ Probiotic Supplement Capsule Formulation

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 2

Locations

Czech Republic

Study Type

Interventional

Intervention

Cardioviva™ supplement capsule

Placebo capsule

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
Signed informed consent form prior to inclusion in the study
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

Exclusion Criteria:

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
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)
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

Sites / Locations

APharma s.r.o.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cardioviva™ supplement capsule

Placebo capsule

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01341613

First Posted

April 22, 2011

Last Updated

November 1, 2011

Sponsor

Micropharma Limited

1. Study Identification

Unique Protocol Identification Number

NCT01341613

Brief Title

Efficacy of Cardioviva™ Probiotic Supplement Capsule Formulation

Official Title

Efficacy of a Supplement Capsule Containing L. Reuteri Cardioviva™ on Managing Cholesterol Levels in Hypercholesterolemic Humans

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Micropharma Limited

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

131 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cardioviva™ supplement capsule

Arm Type

Experimental

Arm Title

Placebo capsule

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Cardioviva™ supplement capsule

Intervention Description

Twice per day (BID), 9 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo capsule

Intervention Description

Twice per day (BID), 9 weeks

Primary Outcome Measure Information:

Title

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

Time Frame

9 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Signed informed consent form prior to inclusion in the study 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 Exclusion Criteria: 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 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) 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

Facility Information:

Facility Name

APharma s.r.o.

City

Prague

Country

Czech Republic

12. IPD Sharing Statement

Citations:

PubMed Identifier

24074303

Citation

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.

Results Reference

derived

PubMed Identifier

23148122

Citation

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.

Results Reference

derived

PubMed Identifier

22561556

Citation

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.

Results Reference

derived

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Efficacy of Cardioviva™ Probiotic Supplement Capsule Formulation

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