Status:
COMPLETED
Efficacy of Cardioviva™ Probiotic Yogurt Formulation
Lead Sponsor:
Micropharma Limited
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-74 years
Phase:
PHASE2
Brief Summary
Background: Several studies have reported limited or no reduction in serum lipid concentrations in response to probiotic formulations. More recently, probiotics have shown promise in treating metaboli...
Eligibility Criteria
Inclusion
- Healthy males and females.
- Aged 18-74 years old.
- Low Density Lipoprotein (LDL-C) above 3.4 mmol/L (\<15% variation between visits V1 and V2-1).
- Triglyceride (TG) levels below 4.0 mmol/l (check at V0 and V2-1).
- Body Mass Index (BMI) range was 22 to 32 kg/m2.
- Ability to understand dietary procedures.
- 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 were permitted to take stable doses of thyroid hormone, anti-hypertensive agents, and contraceptive hormones (e.g. contraceptive pills or patches), as long as these were continued equivalently throughout the duration of study.
Exclusion
- Use of statin or other cholesterol lowering prescription drugs 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 supplements within last 3 months.
- History of chronic use of alcohol (\>2 drinks/day).
- Use of systemic antibodies, corticosteroids, androgens, or phenytoin.
- Myocardial infarction, coronary artery bypass, or other major surgical procedures within the last six months.
- Lactose intolerance or allergies to dairy products.
- History of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, 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 fiber laxative (greater than 2 doses/week), or stimulant laxatives.
- History of eating disorders.
- Exercise greater than 15 miles/week or 4,000 kcal/week.
- Pregnancy, breast feeding, or intent to get pregnant.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01185795
Start Date
September 1 2008
End Date
April 1 2009
Last Update
July 2 2012
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