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The Combined Portfolio Diet and Exercise Study (PortfolioEx)

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ClinicalTrials.gov Identifier: NCT02481466
Recruitment Status : Recruiting
First Posted : June 25, 2015
Last Update Posted : September 17, 2018
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

Study Description
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Brief Summary:
The purpose of this study is to determine whether a dietary portfolio of cholesterol-lowering foods (viscous fibres, soy protein, plant sterols and nuts) further enhanced by increased levels of monounsaturated fatty acids (MUFA) and low glycemic index foods; together with a structured exercise program reduce the progression of carotid and coronary atheromatous lesions, Low density lipoprotein-cholesterol (LDL-C), and blood pressure, while reducing the number of individuals requiring statins.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Hypercholesterolemia Type 2 Diabetes Metabolic Syndrome Behavioral: Portfolio diet and structured exercise Behavioral: DASH-like diet and structured exercise Behavioral: Portfolio diet and routine exercise Behavioral: DASH-like diet and routine exercise Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: This is a 2 x 2 factorial design
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The First Cross-Canada Trial of the Nutrition Trialists' Network--Enhanced Dietary Portfolio and Exercise on Arterial Damage (MRI-Enhanced Dietary Portfolio Plus Exercise on Cardiovascular Risk)
Actual Study Start Date : November 25, 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Portfolio diet and structured exercise
Participants will receive advice on a therapeutic diet appropriate for hypercholesterolemia (ie <7% of energy from saturated fat, <200mg/d cholesterol) PLUS the combination of viscous fibres, soy protein, plant sterols and nuts, 5% extra monounsaturated fat, and selection of low glycemic index foods and be instructed on a standardized physical activity/exercise component supervised by kinesiologists.
 Behavioral: Portfolio diet and structured exercise

Diet: Foods will contribute 9 g/1000 kcal viscous fibre as β-glucan (oats, barley and oat bran breads) and psyllium (cereal), 1 g plant sterol/1000 kcal diet (in sterol margarine), 22.5 g soy protein/1000 kcal (soy burgers and other soy meat analogues, soy milks, yogurts and cheese) and 22.5 g nuts/1000 kcal and increased MUFA (as olive and canola oils, avocados, nuts etc.). The glycemic index will be reduced from 83 to 70 GI units (bread scale).

Exercise: A program encouraging 150 minutes of exercise, based on the Quebec Heart and Lung Institute exercise program. A short submaximal treadmill test will be used to assess cardiorespiratory fitness. A kinesiologist will work with participants using behavioral strategies to achieve the target of 150 min/week of physical activity or exercise in 3 or 5 sessions weekly (vigorous, moderate or mild depending on goals and tolerance). The target goal will be at least 10,000 steps daily.

Other Names:
  • Dietary Portfolio of cholesterol-lowering foods
  • Enhanced portfolio
  • Low Glycemic Index Portfolio
  • Portfolio Plus diet
  • Laval exercise program
  • structured exercise program
  • Portfolio diet
  • structured exercise
Active Comparator: DASH-like diet and structured exercise
Participants will receive advice to follow a DASH-like diet of whole grains, and low-fat dairy products with fruits and vegetables and a be instructed on the Laval exercise program—a standardized physical activity/exercise component supervised by trained kinesiologists (exercise physiologists).
 Behavioral: DASH-like diet and structured exercise

Diet: Participants will be encouraged to follow a diet of whole grain foods (brown rice, whole wheat breads, muffins and breakfast cereals), reduce meat consumption, choose low fat dairy foods and a control margarine.

Exercise: A physical activity/exercise program encouraging 150 minutes of exercise, based on the exercise program developed at the Quebec Heart and Lung Institute. A short submaximal treadmill test will be used to assess cardiorespiratory fitness. A kinesiologist will work with participants using behavioral strategies to develop and support a plan that aims to achieve the target of 150 min/week of physical activity or exercise in 3 or 5 sessions weekly (vigorous, moderate or mild depending of goals and tolerance) in keeping with maximum achievable goals of participants. The target goal will be at least 10,000 steps daily recorded on their pedometers.

Other Names:
  • Modified DASH diet
  • high fibre diet
  • structured exercise program
  • DASH-like diet
  • Laval exercise program
Experimental: Portfolio diet and routine exercise
Participants will receive advice that will conform to the current therapeutic diet appropriate for hypercholesterolemia (ie <7% of energy from saturated fat, <200mg/d cholesterol) PLUS the combination of viscous fibres, soy protein, plant sterols and nuts, 5% extra monounsaturated fat, and selection of low glycemic index foods and will be provided with a copy of Health Canada Physical Activity Guidelines with advice to increase physical activity.
 Behavioral: Portfolio diet and routine exercise

Diet: Foods on the dietary portfolio plan will contribute 9 g/1000 kcal viscous fibre as β-glucan (oats, barley and oat bran breads) and psyllium (cereal), 1 g plant sterol/1000 kcal diet (in sterol margarine), 22.5 g soy protein/1000 kcal (soy burgers and other soy meat analogues, soy milks, yogurts and cheese) and 22.5 g peanuts or equivalent of tree nuts/1000 kcal (Table 1A) and increased MUFA (as olive and canola oils, avocados, nuts etc.). The glycemic index will be reduced from 83 to 70 GI units (bread scale).

Exercise: Participants in this group will receive standard of care for individuals being seen by a general practitioner. They will be advised to achieve the current recommended targets for daily physical activity and educational material published by Health Canada (Canada's Physical Activity Guide, Health Canada). They will undergo treadmill tests at the start and end of each 1 year period. They will not receive the more frequent, targeted visits with a kinesiologist.

Other Names:
  • Dietary Portfolio of cholesterol-lowering foods
  • Enhanced portfolio
  • Low Glycemic Index Portfolio
  • Portfolio Plus diet
  • routine exercise
Active Comparator: DASH-like diet and routine exercise
Participants will receive advice to follow a DASH-like diet of whole grains, and low-fat dairy products with fruits and vegetables and will be provided with a copy of Health Canada Physical Activity Guidelines with advice to increase physical activity.
 Behavioral: DASH-like diet and routine exercise

Diet: Participants will be encouraged to follow a diet of whole grain foods (brown rice, whole wheat breads, muffins and breakfast cereals), reduce meat consumption, choose low fat dairy foods and a control margarine.

Exercise: Participants in this group will receive standard of care for individuals being seen by a general practitioner. They will be advised to achieve the current recommended targets for daily physical activity and educational material published by Health Canada (Canada's Physical Activity Guide, Health Canada). They will undergo treadmill tests at the start and end of each 1 year period. They will not receive the more frequent, targeted visits with a kinesiologist.

Other Names:
  • Modified DASH diet
  • high fibre diet
  • routine exercise


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline of the maximum vessel wall volume of the carotid arteries by MRI at year 1 and 3 [ Time Frame: At months 0, 12 and 36 ]
    MRI imaging assessment of the carotid arteries will be done at baseline, end of year 1 and year 3.


Secondary Outcome Measures :
  1. Coronary atheroma in the large vessels by MRI at year 1 and 3 [ Time Frame: At months 0, 12 and 36 ]
    This will be assessed by MRI imaging of the Coronary and carotid arteries

  2. Lipid rich necrotic core by MRI at year 1 and 3 [ Time Frame: At months 0, 12 and 36 ]
    This will be assessed by MRI imaging of the Coronary and carotid arteries

  3. intra plaque hemorrhage by MRI at year 1 and 3 [ Time Frame: At months 0, 12 and 36 ]
    This will be assessed by MRI imaging of the Coronary and carotid arteries

  4. Blood pressure and pulse rate [ Time Frame: At months 0, 12 and 36 ]
    This is a composite measure that would by done using an automatic digital BP monitor which simultaneously measures and displays systolic and diastolic pressure (mmHg) and pulse rate (bpm) readings on an output screen.

  5. Treatment difference in initiation of statin therapy [ Time Frame: At month 12 and 36 ]
    Assessment will be based on the current Canadian Cardiovascular Society Guidelines

  6. Composite endpoint of Myocardial Infarction, Revascularization, Cardio Vascular hospitalization, Cardiovascular mortality and stroke [ Time Frame: at month 12 and 36 ]
    Information will be obtained from medical records of participants affected

  7. Atrial Fibrillation and heart failure [ Time Frame: at month 12 and 36 ]
    Information will be obtained from medical records of the participants


Other Outcome Measures:
  1. Completeness of clinic attendance and data collection and provision of fasting blood samples for planned tests. [ Time Frame: At months -3, -0.5, and then at months 0, 3, 6, 9,12, 15, 18, 21, 24, 27, 30, 33 and 36 ]
    This will be used as a measure of retention

  2. Serum lipids: total cholesterol, LDL-chol, HDL-chol, and Triglycerides [ Time Frame: At months -3, -0.5, and then at months 0, 3, 6, 9,12, 15, 18, 21, 24, 27, 30, 33 and 36 ]
    Serum lipids will be measured at each Centre on fasting serum. LDL-C will be calculated using the Friedewald equation. Serum lipid standards will be used to quality control the lipid analyses at the collaborating sites

  3. Hemoglobin A1c [ Time Frame: At months -3, -0.5, 0, 3, 6, 9,12, 15, 18, 21, 24, 27, 30, 33 and 36 ]
    safety monitoring especially for participants with type 2 diabetes

  4. C-reactive protein [ Time Frame: At months 0,12, 24 and 36 ]
    C-reactive protein will be measured at each Centre on fasting serum.

  5. Urinary analyses [ Time Frame: At baseline (months -0.5 & 0) and end (months 33 & 36) ]
    24 hr urine samples will be analyzed for creatinine, urea, C-peptide, minerals, electrolytes and other dietary biomarkers

  6. Fasting blood Glucose [ Time Frame: At months -3, -0.5, 0, 3, 6, 9,12, 15, 18, 21, 24, 27, 30, 33 and 36 ]
    safety monitoring especially for participants with type 2 diabetes

  7. Blood Pressure [ Time Frame: At months -3, -0.5, and then at months 0, 3, 6, 9,12, 15, 18, 21, 24, 27, 30, 33 and 36 ]
    In clinic assessment using a digital blood pressure monitor

  8. Treadmill testing [ Time Frame: At month -1, and end of years 1, 2, and 3 ]
    Physical fitness testing to assess fitness level

  9. Diet history [ Time Frame: At months -3, -0.5, and then at months 0, 3, 6, 9,12, 15, 18, 21, 24, 27, 30, 33 and 36 ]
    7-day food records brought in at 3 monthly intervals will be analysed for macro and micro nutrient intakes.

  10. Exercise history [ Time Frame: At months -3, -0.5, and then at months 0, 3, 6, 9,12, 15, 18, 21, 24, 27, 30, 33 and 36 ]
    7-day exercise/ activity records of the week prior to each study visit will be assessed for the type and duration of activity.

  11. Pedometer records [ Time Frame: At months -3, -0.5, and then at months 0, 3, 6, 9,12, 15, 18, 21, 24, 27, 30, 33 and 36 ]
    These will be assessed for the daily step count over a 7-day period prior to the specified time points for the test group only.

  12. Survey on quality of life [ Time Frame: At months 0 and 36. ]
    This will be done using a Medical Outcomes Study 36-Item Short Form Questionnaire (SF-36).

  13. Palatability (taste) of diet [ Time Frame: At months 3, 6, 9,12, 15, 18, 21, 24, 27, 30, 33 and 36 ]
    This will be measure on a scale to 1 to 10. 1 being 'strongly dislike' and 10 being 'like very much'. Participants will rate the taste (palatability) of the study diet and dietary components.

  14. Satiety [ Time Frame: At months 3, 6, 9,12, 15, 18, 21, 24, 27, 30, 33 and 36 ]
    Using a 9-point bipolar semantic scale where -4 is extremely hungry, 0 is neutral and +4 is uncomfortably full, participants will rate their overall feeling of satiety for the previous week

  15. Sustainability of diet (preparedness to continue on the diet) [ Time Frame: At months 33 and 36 ]
    Participants' preparedness to continue on the diet will be measured on a scale of 1 to 10. 1 = diet not sustainable; 10 = diet very sustainable

  16. Genetic testing for specific genes [ Time Frame: Week 0 or any other time point ]
    One time sample collection of buffy coat (from white cells) for future study on gene, diet, exercise and chronic disease relationship

  17. Complete blood count (CBC) [ Time Frame: Months 0, 12, 24 and 36 ]
    Health check at start and yearly intervals

  18. Renal function tests [ Time Frame: Months 0, 12, 24 and 36 ]
    Health check at start and yearly intervals

  19. Liver function tests [ Time Frame: Months 0, 12, 24 and 36 ]
    Health check at start and yearly intervals

  20. Prostatic specific antigen (PSA) [ Time Frame: Months 0, 12, 24 and 36 ]
    Health check at start and yearly intervals for male participants

  21. Cognitive Assessment [ Time Frame: months 0, 12, 24 and 36 ]
    The Montreal Cognitive Assessment (MoCA) (version 7.1 original version) will be administered at months 0, 12, 24 and 36. This tool measures different cognitive domains such as attention, concentration, memory, language etc.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

A) Inclusion Criteria:

  • Eligible participants will be

    • men over 21 years
    • post-menopausal women

Having a BMI less than or equal to 40 kg/m2 and who have measurable arterial thickening (>/=1.2mm) at screening as assessed by ultrasound.

They will include those who have at least 1 of the following characteristics:

  1. Type 2 diabetes
  2. Non-diabetic subjects post MI or post percutaneous coronary intervention (angioplasty) on statin therapy;
  3. Hyper-cholesterolemic and treated with statins or have been prescribed statins but are not taking it because they are either unable (intolerant) or unwilling to take statin drugs.
  4. Raised blood pressure, >140/90 (untreated)

B) Exclusion Criteria:

  • Individuals with the following conditions will be excluded:

    • cardiovascular disease that precludes exercise e.g.

      • recent stroke or
      • recent myocardial infarction or

    • cardiac condition that severely compromises normal function:

      • mitral valve disease, atrial fibrillation and individuals with Implantable Cardioverter Defibrillator (ICD)
      • heart failure--grades 2-4 (based on New York Heart Association classification),
      • severe angina sufficient to prevent any form of physical activity
      • other conditions preventing exercise.
  • secondary causes of hypercholesterolemia e.g. hypothyroidism (unless treated and on a stable dose of L-thyroxin), clinically significant renal (that precludes dietary change) or liver disease .
  • LDL-cholesterol <1.4mmol/L
  • uncontrolled blood pressure
  • major disability

  • disorder requiring continuous medical attention (on Coumadin) and treatment, such as:

    • 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 (eg. lupus, ulcerative colitis, crohn's disease, celiac disease or gluten sensitivity)
    • other autoimmune disease
  • major surgery <6 months prior to randomization
  • newly diagnosed with diabetes (<3 months)
  • alcohol consumption >3 drinks/d
  • not suitable for MRI examination because of metal implants or claustrophobia
  • food allergies or sensitivity to study foods or study food components (eg. tree nuts, peanuts, soy, wheat, gluten, oats, eggs, milk)
  • already following a portfolio-like diet (and are not prepared to change) or have a structured exercise program which they cannot increase any further
  • do not have a family doctor
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481466


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

Locations
Canada, British Columbia
Healthy Heart Lipid Clinic, St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Principal Investigator: Jiri Frohlich, MD         
Canada, Manitoba
Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba Not yet recruiting
Winnipeg, Manitoba, Canada, R3T 6C5
Contact: Peter Jones, PhD         
Principal Investigator: Peter Jones, PhD         
Canada, Ontario
Risk Factor Modification Centre, St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5C 2T2
Contact: David J Jenkins, MD PhD    416-867-7475    David.jenkins@utoronto.ca   
Contact: Dorothea A Faulkner, PhD    416-360-4000 ext 48175    FaulknerD@smh.ca   
Principal Investigator: David J Jenkins, MD PhD         
Sub-Investigator: Cyril Kendall, PhD         
Sub-Investigator: Robert Josse, MD         
Sub-Investigator: Lawrence Leiter, MD         
Sub-Investigator: John Sievenpiper, MD PhD         
Sub-Investigator: Anish Kirpalani, MD         
Canada, Quebec
Institute of Nutraceuticals and Functional Foods, Laval University Recruiting
Quebec City, Quebec, Canada, G1V 4G2
Contact: Benoit Lamarche, PhD         
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 Jenkins, MD Risk Factor Modification Centre, St. Michael's Hospital
Study Director: Benoit Lamarche, PhD Laval University
Study Director: Peter Jones, PhD University of Manitoba
Study Director: Jiri Frohlich, MD University of British Columbia
More Information
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Publications:

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02481466     History of Changes
Other Study ID Numbers: REB # 14-316
FRN 130278 ( Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR) )
FRN 129920 ( Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR) )
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by St. Michael's Hospital, Toronto:
Arterial plaque
Magnetic resonance imaging (MRI)
Portfolio diet
Dietary modification
Dietary trials
hypercholesterolemia
 diabetes
exercise
cardiovascular disease risk
glycemic index (GI)
Carotid Ultrasound
Dietary Approaches to Stop Hypertension (DASH) diet

Additional relevant MeSH terms:
Cardiovascular Diseases
Metabolic Syndrome X
Hypercholesterolemia
Insulin Resistance
Hyperinsulinism
 Glucose Metabolism Disorders
Metabolic Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders