Magnetic Resonance Imaging-Portfolio Diet Study #7

NCT ID: NCT02078635

Last Updated: 2017-04-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2014-10-07

Brief Summary

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?

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.

Conditions

Cardiovascular Diseases; Hypercholesterolemia; Diabetes; Metabolic Syndrome; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

Portfolio Plus Diet

Intervention Type: BEHAVIORAL

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)

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)

Group Type: ACTIVE_COMPARATOR

DASH-like (high fibre) dietary advice

Intervention Type: BEHAVIORAL

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

Interventions

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)

Intervention Type: 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

Intervention Type: BEHAVIORAL

Other Intervention Names

Dietary Portfolio of cholesterol-lowering foods; Enhanced portfolio; Portfolio eating plan; high fibre diet

Eligibility 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David J Jenkins, MD

Role: PRINCIPAL_INVESTIGATOR

St. Michael's Hospital / University of Toronto

Benoit Lamarche, PhD

Role: STUDY_DIRECTOR

Laval University

Peter Jones, PhD

Role: STUDY_DIRECTOR

University of Manitoba

Jiri Frohlich, MD

Role: STUDY_DIRECTOR

University of British Columbia

Locations

Healthy Heart Lipid Clinic, St. Paul's Hospital

Vancouver, British Columbia, Canada

Richardson Center for Functional Foods and Nutraceuticals and the St. Boniface Hospital Cardiovascular Center, University of Manitoba

Winnipeg, Manitoba, Canada

Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, Canada

Institute of Nutraceuticals and Functional Foods and the Quebec Heart and Lung Institute, Laval University

Québec, Quebec, Canada

Countries

Canada

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Other Identifiers

FRN 129920

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

REB 13-260

Identifier Type: -

Identifier Source: org_study_id