Enhanced Multicenter Dietary Portfolio Study (EDP8)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by St. Michael's Hospital, Toronto
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
University of Toronto
Laval University
University of Manitoba
University of British Columbia
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01954472
First received: September 23, 2013
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

"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.


Condition Intervention
Cardiovascular Diseases
Type 2 Diabetes
Hypercholesterolemia
Behavioral: Enhanced portfolio plus structured exercise
Behavioral: High fiber diet plus routine exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of an Enhanced Dietary Portfolio Plus Exercise on Cardiovascular Risk in High Risk Individuals.

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Feasibility measured by recruitment and retention rates [ Time Frame: 1 year in a 9 year study ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • C-reactive protein [ Time Frame: At months -3, -2, -1 and then at months 0, 3, 6 and 12 ] [ Designated as safety issue: No ]
  • Hemoglobin A1c [ Time Frame: At months -3, -2, -1 and then at months 0, 3, 6 and 12 ] [ Designated as safety issue: Yes ]
  • Glucose [ Time Frame: At months -3, -2, -1 and then at months 0, 3, 6 and 12 ] [ Designated as safety issue: Yes ]
  • Blood Pressure [ Time Frame: At months -3, -2, -1 and then at months 0, 3, 6 and 12 ] [ Designated as safety issue: Yes ]
  • treadmill testing [ Time Frame: At months 0 and 12 ] [ Designated as safety issue: No ]
  • diet history [ Time Frame: At months -3, -2, -1 and then at months 0, 3, 6 and12 ] [ Designated as safety issue: No ]
  • Pedometer records [ Time Frame: At months 0, 2, 4, 6, 8, 10 and 12 ] [ Designated as safety issue: No ]
  • Exercise history [ Time Frame: At months 0, 3, 6, and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Other Names:
  • Dietary Portfolio of cholesterol-lowering foods
  • Laval exercise program
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

A) Inclusion Criteria:

Eligible participants will be:

  1. men, over 50
  2. postmenopausal women, over 60 or
  3. postmenopausal women under 60 with a family history of hypercholesterolemia and 1 CVD risk factor.

Participants will have the following characteristics:

  • BMI 25-40 kg/m2 with body weight that has remained constant (within ±3%) over the last 3 months preceding the onset of the study
  • Plus at least 1 of the following 3 criteria:

    1. have type 2 diabetes with one of the following:

      • raised LDL-C(in accordance with the 2012 Canadian Cardiovascular Society Guidelines)
      • raised BP (> 130/80mmHg), or
      • active smoking;
    2. be non-diabetic subjects post MI or post percutaneous coronary intervention (angioplasty) on statin therapy; and
    3. have a modified Framingham risk score >20% (CCS 2012) and are unable (intolerant) or unwilling to take statin drugs.

B) Exclusion Criteria:

Individuals with the following conditions will be excluded:

  • cardiovascular disease that precludes exercise e.g.

    • recent stroke or
    • myocardial infarction, or
  • cardiac condition that compromises normal function

    • mitral valve disease,
    • heart failure--grades 2-4 (New York Heart Association classification),
    • severe angina or
    • other conditions preventing exercise,
  • secondary causes of hypercholesterolemia

    • hypothyroidism, (unless treated and on a stable dose of L-thyroxine)
    • renal or liver disease
  • uncontrolled blood pressure
  • major disability
  • disorder requiring continuous medical attention and treatment:

    • chronic heart failure,
    • liver disease,
    • renal failure or
    • cancer (except non-melanoma skin cancer--basal cell, squamous cell),
  • chronic infections (bacterial or viral)
  • chronic inflammatory diseases (e.g. lupus, ulcerative colitis)
  • other autoimmune diseases
  • major surgery <6 months prior to randomization
  • alcohol consumption >2 drinks/d.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01954472

Contacts
Contact: David J Jenkins, MD 416-867-7475 NutritionProject@smh.ca
Contact: Cyril Kendall, PhD 416-978-6527 cyril.kendall@utoronto.ca

Locations
Canada, British Columbia
Healthy Heart Lipid Clinic, St. Paul's Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Principal Investigator: Jiri Frohlich, MD         
Canada, Manitoba
Richardson Center for Functional Foods and Nutraceuticals and the St. Boniface Hospital Cardiovascular Center, University of Manitoba Not yet recruiting
Winnipeg, Manitoba, Canada, R3T 6C5
Principal Investigator: Peter Jones, PhD         
Canada, Ontario
Risk Factor Modification Centre, St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5C 2T2
Contact: David J Jenkins, MD    416-867-7475    NutritionProject@smh.ca   
Contact: Dorothea A Faulkner, PhD    416-867-7460 ext 8175    FaulknerD@smh.ca   
Principal Investigator: David J Jenkins, MD         
Sub-Investigator: Michael Farkouh, MD         
Sub-Investigator: Robert Josse, MD         
Sub-Investigator: Lawrence Leiter, MD         
Canada, Quebec
Institute of Nutraceuticals and Functional Foods and the Quebec Heart and Lung Institute, Laval University Not yet recruiting
Quebec City, Quebec, Canada, G1V 4G2
Principal Investigator: Benoit Lamarche, PhD         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Canadian Institutes of Health Research (CIHR)
University of Toronto
Laval University
University of Manitoba
University of British Columbia
Investigators
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
  More Information

Publications:

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01954472     History of Changes
Other Study ID Numbers: REB 13-188, FRN 130278
Study First Received: September 23, 2013
Last Updated: September 30, 2013
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
Portfolio diet
dietary modification
diabetes
hypercholesterolemia
Exercise
CVD risk
glycemic index
inflammatory biomarkers
monounsaturated fat
saturated fat
nuts
plant sterols
vegetable protein
viscous fiber
soy

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypercholesterolemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on August 26, 2014