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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 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:
NCT02078635
First received: February 18, 2014
Last updated: March 3, 2014
Last verified: January 2014
  Purpose

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?


Condition Intervention
Cardiovascular Diseases
Hypercholesterolemia
Diabetes
Metabolic Syndrome
Obesity
Behavioral: Portfolio Plus Diet
Behavioral: DASH-like (high fibre) dietary advice

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 Canada-wide Human Nutrition Trialists' Network

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline of the maximum vessel wall volume of the carotid arteries [ Time Frame: At baseline and year 3 ] [ Designated as safety issue: No ]
    Assessed by MRI


Secondary Outcome Measures:
  • Intra-plaque hemorrhage (IPH) [ Time Frame: At baseline and year 3 ] [ Designated as safety issue: No ]
    Assessed by MRI

  • Intra-plaque lipid (lipid-rich necrotic core) [ Time Frame: baseline and year 3 ] [ Designated as safety issue: No ]
    Assessed by MRI

  • blood pressure and pulse rate [ Time Frame: At months 0, 3, 6, 12, 18, 24, 30, 36 ] [ Designated as safety issue: No ]
  • initiation of statin therapy [ Time Frame: baseline and year 3 ] [ Designated as safety issue: No ]
    According to current CCS guidelines


Other Outcome Measures:
  • LDL-cholesterol [ Time Frame: At months, 0, 3, 6, 12, 18, 24, 30, 36 ] [ Designated as safety issue: No ]
  • HDL-cholesterol [ Time Frame: months 0, 3, 6, 12, 18, 24, 30, 36 ] [ Designated as safety issue: No ]
  • C-reactive protein (CRP) [ Time Frame: At months 0, 12, 24, and 36 ] [ Designated as safety issue: No ]
  • The Medical Outcomes Study 36-Item Short Form Questionnaire (SF-36) [ Time Frame: Months 0 and 36 ] [ Designated as safety issue: No ]
    Survey on quality of life.

  • Genetic whole genome testing [ Time Frame: month 0 ] [ Designated as safety issue: No ]
    One time sample collection of buffy coat white cells for future analysis

  • satiety of the test and control diet [ Time Frame: Months 0, 3, 6, 12, 18, 24, 30, 36 ] [ Designated as safety issue: No ]
    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).

  • Palatability of the test / control diets [ Time Frame: Months 3, 6, 12, 18, 24, 30, and 36 ] [ Designated as safety issue: No ]
    The palatability of the diet will by measured using a numerical scale of 1 to 10 (1= strongly dislike and 10 = like very much).


Estimated Enrollment: 194
Study Start Date: October 2014
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: high fibre diet

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT02078635

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: 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 Frohlich, MD University of British Columbia
  More Information

Publications:

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02078635     History of Changes
Other Study ID Numbers: REB 13-260, FRN 129920
Study First Received: February 18, 2014
Last Updated: March 3, 2014
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
Arterial plaque
portfolio diet
dietary modification
dietary trials
Canadian Network
knowledge synthesis and translation
Magnetic resonance imaging

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypercholesterolemia
Obesity
Metabolic Syndrome X
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on August 26, 2014