Efficacy of Cardioviva™ Probiotic Supplement Capsule Formulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Micropharma Limited
ClinicalTrials.gov Identifier:
NCT01341613
First received: April 22, 2011
Last updated: November 1, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Hypercholesterolemia
Dietary Supplement: Cardioviva™ supplement capsule
Dietary Supplement: Placebo capsule
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Supplement Capsule Containing L. Reuteri Cardioviva™ on Managing Cholesterol Levels in Hypercholesterolemic Humans

Resource links provided by NLM:


Further study details as provided by Micropharma Limited:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 131
Study Start Date: May 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cardioviva™ supplement capsule Dietary Supplement: Cardioviva™ supplement capsule
Twice per day (BID), 9 weeks
Placebo Comparator: Placebo capsule Dietary Supplement: Placebo capsule
Twice per day (BID), 9 weeks

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01341613

Locations
Czech Republic
APharma s.r.o.
Prague, Czech Republic
Sponsors and Collaborators
Micropharma Limited
  More Information