Enhanced Multicenter Dietary Portfolio Study (EDP8)
|Cardiovascular Diseases Type 2 Diabetes Hypercholesterolemia||Behavioral: Enhanced portfolio plus structured exercise Behavioral: High fiber diet plus routine exercise|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
|Official Title:||The Effect of an Enhanced Dietary Portfolio Plus Exercise on Cardiovascular Risk in High Risk Individuals.|
- Feasibility measured by recruitment and retention rates [ Time Frame: 1 year in a 9 year study ]
Pilot study: Recruitment and retention rates will establish the feasibility of proceeding to the large RCT ie the 9 year intervention study.
Long term study (9 years intervention): Non-fatal MI, non-fatal stroke and CV mortality as defined by MACE.
- Serum lipids: total cholesterol, LDL-chol, HDL-chol and Triglycerides [ Time Frame: At months -3, -2, -1 and then at months 0, 3, 6 and 12 ]
- C-reactive protein [ Time Frame: At months -3, -2, -1 and then at months 0, 3, 6 and 12 ]
- Hemoglobin A1c [ Time Frame: At months -3, -2, -1 and then at months 0, 3, 6 and 12 ]
- Glucose [ Time Frame: At months -3, -2, -1 and then at months 0, 3, 6 and 12 ]
- Blood Pressure [ Time Frame: At months -3, -2, -1 and then at months 0, 3, 6 and 12 ]
- treadmill testing [ Time Frame: At months 0 and 12 ]
- diet history [ Time Frame: At months -3, -2, -1 and then at months 0, 3, 6 and12 ]
- Pedometer records [ Time Frame: At months 0, 2, 4, 6, 8, 10 and 12 ]
- Exercise history [ Time Frame: At months 0, 3, 6, and 12 ]
|Study Completion Date:||October 7, 2014|
|Primary Completion Date:||October 7, 2014 (Final data collection date for primary outcome measure)|
Experimental: Enhanced Portfolio plus structured exercise
Diet: The dietary portfolio advice: to limit saturated fat to <7% of total calories and cholesterol to <200 mg/d) plus inclusion of viscous fibres, soy protein, plant sterols and nuts, 5% extra monounsaturated fat, and selection of low glycemic index foods and will emphasize current recommendations for fruit and vegetable intakes (5-10 servings/d).
Behavioral: Enhanced portfolio plus structured exercise
Foods on the dietary portfolio plan will contribute 9g/1000 kcal viscous fibre as β-glucan (oats, barley, oat bran breads and soups) and psyllium (cereal), 1g plant sterol/1000 kcal diet (in sterol margarine), 22.5g soy protein/1000 kcal (soy burgers, dogs, links, other soy meat analogues, soy milks, yogurts and cheese), and additional sources of plant protein from pulses (eg. Lentils, chickpeas, beans, etc) and 22.5g almonds or equivalent of other nuts/1000 kcal and increased 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).
Exercise: The physical activity/exercise program is based on the program used at the Quebec Heart and Lung Institute.
Active Comparator: High fiber diet plus routine exercise
A diet of whole grain foods (brown rice, whole wheat breads, muffins and breakfast cereals); reduced meat consumption; lower fat dairy foods and a control margarine
Behavioral: High fiber diet plus routine exercise
Dietary advice will be given to encourage intake of whole grain foods (brown rice, whole wheat breads, muffins and breakfast cereals); to reduce meat consumption, choose low fat dairy products and a control margarine.
Exercise: A pamphlet (Canada's Physical Activity Guide, Health Canada) encouraging increased physical activity will be provided.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01954472
|Canada, British Columbia|
|Healthy Heart Lipid Clinic, St. Paul's Hospital|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Richardson Center for Functional Foods and Nutraceuticals and the St. Boniface Hospital Cardiovascular Center, University of Manitoba|
|Winnipeg, Manitoba, Canada, R3T 6C5|
|Risk Factor Modification Centre, St. Michael's Hospital|
|Toronto, Ontario, Canada, M5C 2T2|
|Institute of Nutraceuticals and Functional Foods and the Quebec Heart and Lung Institute, Laval University|
|Quebec City, Quebec, Canada, G1V 4G2|
|Principal Investigator:||David J Jenkins, MD||St. Michael's Hospital / University of Toronto|
|Study Director:||Benoit lamarche, PhD||Laval University|
|Study Director:||Peter Jones, PhD||University of Manitoba|
|Study Director:||Jiri Frohilich, MD||University of British Columbia|