The Combined Portfolio Diet and Exercise Study (PortfolioEx)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02481466 |
Recruitment Status :
Recruiting
First Posted : June 25, 2015
Last Update Posted : October 10, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |

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 |

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:
|
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:
|
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:
|
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:
|
- 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.
- 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
- 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
- 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
- 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.
- 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
- 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
- Atrial Fibrillation and heart failure [ Time Frame: at month 12 and 36 ]Information will be obtained from medical records of the participants
- 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
- 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
- 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
- C-reactive protein [ Time Frame: At months 0,12, 24 and 36 ]C-reactive protein will be measured at each Centre on fasting serum.
- 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
- 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
- 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
- Treadmill testing [ Time Frame: At month -1, and end of years 1, 2, and 3 ]Physical fitness testing to assess fitness level
- 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.
- 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.
- 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.
- 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).
- 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.
- 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
- 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
- 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
- Complete blood count (CBC) [ Time Frame: Months 0, 12, 24 and 36 ]Health check at start and yearly intervals
- Renal function tests [ Time Frame: Months 0, 12, 24 and 36 ]Health check at start and yearly intervals
- Liver function tests [ Time Frame: Months 0, 12, 24 and 36 ]Health check at start and yearly intervals
- Prostatic specific antigen (PSA) [ Time Frame: Months 0, 12, 24 and 36 ]Health check at start and yearly intervals for male participants
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- Type 2 diabetes
- Non-diabetic subjects post MI or post percutaneous coronary intervention (angioplasty) on statin therapy;
- 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.
- 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

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
Contact: David J Jenkins, MD | 416-867-7475 | NutritionProject@smh.ca | |
Contact: Cyril Kendall, PhD | 416-867-7475 | cyril.kendall@utoronto.ca |
Canada, British Columbia | |
Healthy Heart Lipid Clinic, St. Paul's Hospital | Active, not recruiting |
Vancouver, British Columbia, Canada, V6Z 1Y6 | |
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 Dorothea.Faulkner@unityhealth.to | |
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 | Active, not recruiting |
Quebec City, Quebec, Canada, G1V 4G2 |
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 |
Responsible Party: | Unity Health Toronto |
ClinicalTrials.gov Identifier: | NCT02481466 |
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: | October 10, 2019 |
Last Verified: | October 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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 |
Cardiovascular Diseases Metabolic Syndrome Hypercholesterolemia Insulin Resistance Hyperinsulinism |
Glucose Metabolism Disorders Metabolic Diseases Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders |