Efficacy of Cardioviva™ Probiotic Supplement Capsule Formulation
NCT ID: NCT01341613
Last Updated: 2011-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
131 participants
INTERVENTIONAL
2011-05-31
2011-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cardioviva™ supplement capsule
Cardioviva™ supplement capsule
Twice per day (BID), 9 weeks
Placebo capsule
Placebo capsule
Twice per day (BID), 9 weeks
Interventions
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Cardioviva™ supplement capsule
Twice per day (BID), 9 weeks
Placebo capsule
Twice per day (BID), 9 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
75 Years
ALL
No
Sponsors
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Micropharma Limited
INDUSTRY
Responsible Party
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Locations
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APharma s.r.o.
Prague, , Czechia
Countries
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References
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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.
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.
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.
Other Identifiers
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MP-0110
Identifier Type: -
Identifier Source: org_study_id