Magnetic Resonance Imaging-Portfolio Diet Study #7
NCT02078635 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2017-04-27
Summary
Presently in Canada, 29% of deaths are due to cardiovascular disease (CVD), costing $20.9 billion annually. The investigators have, therefore, brought together an unique network of investigators at different stages in their careers with a range of disciplines (nutrition, cardiology, diabetes, imaging, physics, clinical trials, statistics, laboratory medicine, primary care, genetics, psychology, knowledge translation (KT), and epidemiology) and with international recognition , experience and connections, to undertake a multi-centre study which will test the ability of the dietary Portfolio PLUS approach over 3 years to reduce the progression of plaque build-up in the carotid artery as assessed by Magnetic Resonance Imaging (MRI) in individuals with hypercholesterolemia.
The dietary portfolio of cholesterol-lowering foods (viscous fibres, soy protein, plant sterol and nuts) which has been proven in many of their studies to be an effective cholesterol-lowering diet will be further enhanced by increased levels of monounsaturated fats (MUFA) and low glycemic index foods. Will this enhanced dietary strategy (dietary Portfolio PLUS ) reduce the progression of carotid atheromatous lesions, LDL-C and blood pressure while reducing the number of hyperlipidemic individuals requiring statins?
Conditions
- Cardiovascular Diseases
- Hypercholesterolemia
- Diabetes
- Metabolic Syndrome
- Obesity
Interventions
- BEHAVIORAL
-
Portfolio Plus Diet
Foods on the Portfolio Plus plan will contribute 9 g/1000 kcal viscous fibre as β-glucan (oats, barley, oat bran bread and soups) and psyllium (cereal), 1 g plant sterol/1000 kcal diet (in sterol margarine), 22.5 g soy protein/1000 kcal (soy burgers, dogs, links, other soy meat analogues, soy milks, yogurts and cheese) and additional sources of plant proteins from pulses (eg. lentils, chickpeas, beans, etc); and 22.5 g almonds or equivalent of other nuts/1000 kcal and increase MUFA (as olive and canola oils, avocados, nuts, margarine and salad dressings). The glycemic index will be reduced from 83 to 70 GI units (bread scale)
- BEHAVIORAL
-
DASH-like (high fibre) dietary advice
Dietary advice will be given to encourage intake of whole grain foods (brown rice, whole wheat breads, muffins and breakfast cereals); to reduce red meat consumption, choose low fat dairy foods and a control margarine
Sponsors & Collaborators
-
Canadian Institutes of Health Research (CIHR)
collaborator OTHER_GOV -
University of Toronto
collaborator OTHER -
Laval University
collaborator OTHER -
University of Manitoba
collaborator OTHER -
University of British Columbia
collaborator OTHER -
Unity Health Toronto
lead OTHER
Principal Investigators
-
David J Jenkins, MD · St. Michael's Hospital / University of Toronto
-
Benoit Lamarche, PhD · Laval University
-
Peter Jones, PhD · University of Manitoba
-
Jiri Frohlich, MD · University of British Columbia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Primary Completion
- 2014-10-07
- Completion
- 2014-10-07
Countries
- Canada
Study Locations
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