Enhanced Multicenter Dietary Portfolio Study

Summary

"Is it possible to recruit and retain up to 200 participants in a Randomize Control Trial (RCT) of high impact lifestyle approach of diet and exercise designed to significantly reduce cardiovascular events in middle-aged and older men and women at high risk of such events?" To address this question, we propose a pilot study of 3 years in duration: 1 year recruitment and randomization, a full year of intervention for all recruited participants, and the last 6 months to assess the one year data and prepare and submit the full trial application, informed by the pilot study outcomes in terms of retention rate. The pilot will then continue on for the full 9 years of intervention and be rolled into the main study involving additional Canadian centers and collaborating international centers in the US, Britain, Europe, Australia, New Zealand, India, and South Africa.

Conditions

• Cardiovascular Diseases
• Type 2 Diabetes
• Hypercholesterolemia

Interventions

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.

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.

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 Frohilich, MD · University of British Columbia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Primary Completion

2014-10-07

Completion

2014-10-07

Countries

• Canada

Study Locations