Efficacy of Cardioviva™ Probiotic Supplement Capsule Formulation

Launched by MICROPHARMA LIMITED · Apr 22, 2011

Keywords

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Gender

ALL

Eligibility 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