Status:
COMPLETED
Efficacy of Sterol Enhanced Soy Beverage on Cholesterol Metabolism, Inflammation and Oxidative Status in Humans
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
WhiteWave Foods, Inc.
Conditions:
Coronary Heart Disease
Eligibility:
All Genders
19-60 years
Phase:
PHASE2
Brief Summary
It is becoming increasingly clear that North Americans prefer dietary approaches to enhance health in favour of pharmaceutical approaches. Although the consumption of various phytosterol (PS)-enriched...
Eligibility Criteria
Inclusion
- Healthy males and females, aged 19-60 yr, will be screened for determination of fasting circulating LDL-cholesterol and TG levels.
- Subjects accepted into the study will have plasma LDL-C 130-200 mg/dl, TG levels below 250 mg/dl.
- The inclusion for body mass index (BMI) range will be 22 to 32 kg/m2.
- Subjects must also demonstrate an ability to understand dietary procedures and exercise procedures and be judged as compliant and motivated by the investigators.
- 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.
Exclusion
- History of recent (i.e. less than 3 months) or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 6 months.
- History of chronic use of alcohol (\> 2 drinks/day), 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, 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).
- 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 :
August 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00924391
Start Date
September 1 2007
End Date
August 1 2008
Last Update
June 18 2009
Active Locations (1)
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1
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, Canada, R3T 2N2