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Portfolio diet and structured exercise for Metabolic Syndrome (PortfolioEx Trial)

N/A
Waitlist Available
Led By David Jenkins, MD
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non-diabetic subjects post MI or post percutaneous coronary intervention (angioplasty) on statin therapy;
Eligible participants will be
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at months -3, -0.5, 0, 3, 6, 9,12, 15, 18, 21, 24, 27, 30, 33 and 36
Awards & highlights

PortfolioEx Trial Summary

This trial will test whether a healthy diet and exercise can help reduce heart disease.

Eligible Conditions
  • Metabolic Syndrome
  • High Cholesterol
  • Type 2 Diabetes
  • Cardiovascular Disease

PortfolioEx Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

PortfolioEx Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at months -3, -0.5, 0, 3, 6, 9,12, 15, 18, 21, 24, 27, 30, 33 and 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and at months -3, -0.5, 0, 3, 6, 9,12, 15, 18, 21, 24, 27, 30, 33 and 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline of the maximum vessel wall volume of the carotid arteries by MRI at year 1 and 3
Secondary outcome measures
Atrial Fibrillation and heart failure
Blood pressure and pulse rate
Composite endpoint of Myocardial Infarction, Revascularization, Cardio Vascular hospitalization, Cardiovascular mortality and stroke
+4 more
Other outcome measures
Blood Pressure
C-reactive protein
Cognitive Assessment
+18 more

PortfolioEx Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Portfolio diet and structured exerciseExperimental Treatment1 Intervention
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.
Group II: Portfolio diet and routine exerciseExperimental Treatment1 Intervention
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.
Group III: DASH-like diet and structured exerciseActive Control1 Intervention
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).
Group IV: DASH-like diet and routine exerciseActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Portfolio diet and structured exercise
2016
N/A
~240
Portfolio diet and routine exercise
2016
N/A
~240

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
533 Previous Clinical Trials
446,231 Total Patients Enrolled
4 Trials studying Metabolic Syndrome
69 Patients Enrolled for Metabolic Syndrome
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,333 Previous Clinical Trials
25,747,126 Total Patients Enrolled
27 Trials studying Metabolic Syndrome
2,263 Patients Enrolled for Metabolic Syndrome
University of TorontoOTHER
687 Previous Clinical Trials
1,018,063 Total Patients Enrolled
22 Trials studying Metabolic Syndrome
726 Patients Enrolled for Metabolic Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
~28 spots leftby Mar 2025