Efficacy of Cardioviva™ Probiotic Supplement Capsule Formulation

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01341613
• Other study ID #: MP-0110
• Status: Completed
• Phase: Phase 2
• First received: April 22, 2011
• Last updated: November 1, 2011
• Start date: May 2011
• Est. completion date: October 2011

Study information

• Verified date: November 2011
• Source: Micropharma Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• Cardioviva™ supplement capsule
Twice per day (BID), 9 weeks
• Placebo capsule
Twice per day (BID), 9 weeks

Locations

Country	Name	City	State
Czech Republic	APharma s.r.o.	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Micropharma Limited

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be the percent difference in LDL-cholesterol from baseline to endpoint comparing subjects receiving treatment and placebo		9 weeks	No