Magnetic Resonance Imaging-Portfolio Diet Study #7 (MRIPD#7)

April 25, 2017 updated by: Unity Health Toronto

The Canada-wide Human Nutrition Trialists' Network

Presently in Canada, 29% of deaths are due to cardiovascular disease (CVD), costing $20.9 billion annually. The investigators have, therefore, brought together an unique network of investigators at different stages in their careers with a range of disciplines (nutrition, cardiology, diabetes, imaging, physics, clinical trials, statistics, laboratory medicine, primary care, genetics, psychology, knowledge translation (KT), and epidemiology) and with international recognition , experience and connections, to undertake a multi-centre study which will test the ability of the dietary Portfolio PLUS approach over 3 years to reduce the progression of plaque build-up in the carotid artery as assessed by Magnetic Resonance Imaging (MRI) in individuals with hypercholesterolemia.

The dietary portfolio of cholesterol-lowering foods (viscous fibres, soy protein, plant sterol and nuts) which has been proven in many of their studies to be an effective cholesterol-lowering diet will be further enhanced by increased levels of monounsaturated fats (MUFA) and low glycemic index foods. Will this enhanced dietary strategy (dietary Portfolio PLUS ) reduce the progression of carotid atheromatous lesions, LDL-C and blood pressure while reducing the number of hyperlipidemic individuals requiring statins?

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

As Western populations age and as body weight increases, the need for dietary strategies to reduce Coronary Heart Disease (CHD) risk continues. The investigators are now in a position to put together a dietary approach which will be a significant advance over current dietary advice for CHD risk reduction. The investigators believe this study using imaging and functional techniques is now needed to 1) demonstrate an improvement in estimated CHD risk based on anatomical changes rather than serum risk factors. 2) encourage popular uptake and clinical use of this combination dietary strategy and 3) stimulate a larger longer term trial with CHD events.

Participants for this study will be recruited in 4 academic centres across Canada (Quebec, Toronto, Winnipeg and Vancouver). They will be in the low or moderate risk category based on the current Canadian Cardiovascular Society's (CCS) Guidelines 2012 and would normally be considered for initial treatment with lifestyle only. All participants will first be screened by ultrasound for the presence of plaque in the carotid arteries and will then be randomized to one of the 2 treatment arms: Portfolio Plus diet (test) or modified DASH diet (control), both given as routine clinical advice with follow up visits at 3-month intervals for 6 months and then twice yearly for the remainder of the 3 year trial.

Prior to starting either diet, participants will undergo screening ultrasound examination of both right and left carotids to enable selection of those individuals whose intima-media thickness would be 5-30% below the cut point considered by the Mannheim Consensus as relevant arterial thickening to ensure a relatively low risk group, yet with some measurable arterial thickening. The main outcome will be MRI assessment of maximum vessel wall volume. This assessment will be repeated at year 3. It will be emphasized at the outset that both the dietary portfolio and the DASH-like diets have been associated with benefits in terms of cholesterol reduction to provide equal encouragement for those randomized to the test and control groups. Portfolio and DASH-like dietary advice will consist of half hour individual sessions with the dietitian at baseline, 3, and 6 months and then at 6-month intervals. Prior to starting each diet, instruction will be given on achieving the dietary goals.

At follow-up visits, the participants' completed 7-day diet records will be discussed and the original advice reinforced. Every effort will be made to obtain study blood samples and carotid imaging data from all subjects at the designated times regardless of adherence to the dietary aspects of the study protocol. All subjects will be included in the intention-to-treat analysis.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Healthy Heart Lipid Clinic, St. Paul's Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3T 6C5
        • Richardson Center for Functional Foods and Nutraceuticals and the St. Boniface Hospital Cardiovascular Center, University of Manitoba
    • Ontario
      • Toronto, Ontario, Canada, M5C 2T2
        • Risk Factor Modification Centre, St. Michael's Hospital
    • Quebec
      • Quebec City, Quebec, Canada, G1V 4G2
        • Institute of Nutraceuticals and Functional Foods and the Quebec Heart and Lung Institute, Laval University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Eligible participants will be:

  1. Adult males that are within 30% of their target LDL-cholesterol for the low or moderate risk category according to the 2012 Canadian Cardiovascular Society Guidelines.
  2. Postmenopausal women that are within 30% of their target LDL-cholesterol for the low or moderate risk category according to the 2012 Canadian Cardiovascular Society Guidelines.

Participants will have the following characteristics:

  • BMI 25-40 kg/m2 with body weight that has remained constant (within ±2kg) over the last 3 months preceding the onset of the study.
  • Measurable arterial thickening at screening (carotid intima-media thickness of >1.0mm)

  • Plus at least 1 of the following 3 criteria:

    • are treated with statins
    • are statin intolerant
    • have refused statin treatment after consultation with the appropriate physician

Exclusion Criteria:

Individuals with the following conditions will be excluded:

  • major cardiovascular event

    • stroke or
    • myocardial infarction

  • Cardiac conditions that compromise normal function

    • mitral valve disease
    • heart failure
    • angina
  • familial hypercholesterolemia

  • secondary causes of hypercholesterolemia

    • hypothyroidism (unless treated and on a stable dose of L-thyroxine)
    • renal or liver disease
  • diabetes
  • serum triglycerides >4.5 mmol/L
  • uncontrolled blood pressure
  • major disability

  • disorders requiring continuous medical attention and treatment

    • chronic heart failure
    • liver disease
    • renal failure
    • cancer (except non-melanoma skin cancer--basal cell, squamous cell)
  • chronic infections (bacterial or viral)
  • chronic inflammatory diseases ( lupus, ulcerative colitis)
  • other autoimmune diseases (eg celiac disease or gluten sensitivity)
  • major surgery <6 months prior to randomization
  • conditions that make them unsuitable for MRI (e.g. have metal implants or are claustrophobic)
  • alcohol consumption >2 drinks/ day

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Portfolio Plus Diet
Participants will be advised to follow a low glycemic index dietary portfolio. Specifically, the advice will be 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; emphasizing current recommendations for fruit and vegetable intakes (5-10 servings/d)
Behavioral: Portfolio Plus Diet
Foods on the Portfolio Plus plan will contribute 9 g/1000 kcal viscous fibre as β-glucan (oats, barley, oat bran bread and soups) and psyllium (cereal), 1 g plant sterol/1000 kcal diet (in sterol margarine), 22.5 g soy protein/1000 kcal (soy burgers, dogs, links, other soy meat analogues, soy milks, yogurts and cheese) and additional sources of plant proteins from pulses (eg. lentils, chickpeas, beans, etc); and 22.5 g almonds or equivalent of other nuts/1000 kcal and increase 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)
Other Names:
  • Dietary Portfolio of cholesterol-lowering foods
  • Enhanced portfolio
  • Portfolio eating plan
ACTIVE_COMPARATOR: DASH-like (high fibre) diet
The DASH-like dietary advice will emphasize a diet of whole grains, low-fat dairy and current recommendations for fruit and vegetables (5-10 servings/day)
Behavioral: DASH-like (high fibre) dietary advice
Dietary advice will be given to encourage intake of whole grain foods (brown rice, whole wheat breads, muffins and breakfast cereals); to reduce red meat consumption, choose low fat dairy foods and a control margarine
Other Names:
  • high fibre diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of the maximum vessel wall volume of the carotid arteries
Time Frame: At baseline and year 3
Assessed by MRI
At baseline and year 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-plaque hemorrhage (IPH)
Time Frame: At baseline and year 3
Assessed by MRI
At baseline and year 3
Intra-plaque lipid (lipid-rich necrotic core)
Time Frame: baseline and year 3
Assessed by MRI
baseline and year 3
blood pressure and pulse rate
Time Frame: At months 0, 3, 6, 12, 18, 24, 30, 36
At months 0, 3, 6, 12, 18, 24, 30, 36
initiation of statin therapy
Time Frame: baseline and year 3
According to current CCS guidelines
baseline and year 3

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
LDL-cholesterol
Time Frame: At months, 0, 3, 6, 12, 18, 24, 30, 36
At months, 0, 3, 6, 12, 18, 24, 30, 36
HDL-cholesterol
Time Frame: months 0, 3, 6, 12, 18, 24, 30, 36
months 0, 3, 6, 12, 18, 24, 30, 36
C-reactive protein (CRP)
Time Frame: At months 0, 12, 24, and 36
At months 0, 12, 24, and 36
The Medical Outcomes Study 36-Item Short Form Questionnaire (SF-36)
Time Frame: Months 0 and 36
Survey on quality of life.
Months 0 and 36
Genetic whole genome testing
Time Frame: month 0
One time sample collection of buffy coat white cells for future analysis
month 0
satiety of the test and control diet
Time Frame: Months 0, 3, 6, 12, 18, 24, 30, 36
Participants will assess their level of satiety on the test/control diet at each visit using a 9-point bipolar semantic scale ranging from -4 (being starved/ feeling weak and faint with hunger) to +4 (being Painfully full) with 0 being neutral (ie don't mind eating a little more or less).
Months 0, 3, 6, 12, 18, 24, 30, 36
Palatability of the test / control diets
Time Frame: Months 3, 6, 12, 18, 24, 30, and 36
The palatability of the diet will by measured using a numerical scale of 1 to 10 (1= strongly dislike and 10 = like very much).
Months 3, 6, 12, 18, 24, 30, and 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Collaborators

University of Manitoba
University of British Columbia
Canadian Institutes of Health Research (CIHR)
University of Toronto
Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (ACTUAL)

October 7, 2014

Study Completion (ACTUAL)

October 7, 2014

Study Registration Dates

First Submitted

February 18, 2014

First Submitted That Met QC Criteria

March 3, 2014

First Posted (ESTIMATE)

March 5, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB 13-260
  • FRN 129920 (Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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