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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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