Portfolio 5 - Multicentre
The purpose of this trial is to re-evaluate the potential role of diet in modulating cardiovascular risk factors. If potent lipid-lowering effects through novel dietary interventions can be demonstrated, then diet may again be seen as providing an alternative to drug therapy in the primary prevention of cardiovascular disease.
- To determine the percentage of lipid clinic attendees interested in making a serious dietary change.
- To determine the extent to which a self selected dietary portfolio combining viscous fiber foods (oat & barley β-glucan, psyllium, etc.), soy and vegetable protein foods (soy milk, soy meat analogues and almonds) and plant sterols (sterol margarine) in the same diet be significantly more effective in reducing LDL-cholesterol and other markers of cardiovascular disease risk than conventional dietary advice.
- To determine whether this effect can be maximized by more frequent follow-up, and what, if any, would be the relationship between dietary compliance and reduction in LDL-C.
Behavioral: Effects of a self-selected dietary portfolio on cholesterol reduction
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Assessment of the Practical Application, Acceptability and Effectiveness of a Portfolio Diet in Reducing Serum Cholesterol|
|Study Start Date:||January 2007|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
|Canada, British Columbia|
|Healthy Heart Program, St. Paul's Hospital|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba|
|Winnipeg, Manitoba, Canada, R3T 6C5|
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5C 2T2|
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Institute on Nutraceuticals and Functional Foods and the Lipid Research Center, Laval University Hospital Research Center|
|Quebec City, Quebec, Canada, G1V 4G2|
|Principal Investigator:||David J.A. Jenkins, MD, PhD||University of Toronto, St. Michael's Hospital|
|Study Director:||Cyril W.C. Kendall, PhD||University of Toronto, St. Michael's Hospital|
|Study Chair:||Dorothea Faulkner, PhD||St. Michael's Hospital, Toronto|
|Study Director:||Benoit Lamarche, PhD||Lipid Research Clinic & Institute on Nutraceuticals and Functional Foods, Laval University|
|Study Director:||Peter Jones, PhD||Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba|
|Study Director:||Jiri Frohlich, MD||Healthy Heart Program, St. Paul's Hospital, Vancouver BC.|
|Study Director:||Jay Silverberg, MD||Sunnybrooke Health Science Centre|