Status:
COMPLETED
Efficacy of Two Yogurt Formulations in Healthy Humans
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
Micropharma Limited
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This study is to evaluate the safety and efficacy of consumption of: L.Ruteri containing yogurt, L.Fermentum containing yogurt VERSUS placebo on plasma lipids, as well as gastrointestinal microflora d...
Eligibility Criteria
Inclusion
- Healthy males and females
- aged 18-60 yr
- plasma LDL-C 130-260 mg/dl
- TG levels below 400 mg/dl
- body mass index (BMI) rangewill be 22 to 32 kg/m2
- permitted to take stable doses of thyroid hormone and anti hypertensive agents, as long as these are continued equivalently throughout the duration of study
Exclusion
- history of recent (i.e. less than 3 mo) or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 6 mo, - history of chronic use of alcohol (\>2 drinks/d), systemic antibodies, corticosteroids, androgens, or phenytoin,
- myocardial infarction, coronary artery bypass, or other major surgical procedures within the last six months
- recent onset of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, lactose intolerance or significant current (ie. onset within past three months) gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year
- chronic user of probiotics, fiber laxative (greater than 2 doses/wk), or stimulant laxatives or has a history of eating disorders, exercise greater than 15 miles/wk or 4,000 kcal/wk.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01409668
Start Date
September 1 2007
End Date
June 1 2010
Last Update
August 4 2011
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