Magnetic Resonance Imaging-Portfolio Diet Study #7

NCT02078635 | Withdrawn

• 2 other identifiers: REB 13-260FRN 129920
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

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?

Conditions

Cardiovascular Diseases; Hypercholesterolemia; Diabetes; Metabolic Syndrome; Obesity

Keywords

Arterial plaque; portfolio diet; dietary modification; dietary trials; Canadian Network; knowledge synthesis and translation; Magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Change from baseline of the maximum vessel wall volume of the carotid arteries

  Assessed by MRI

  At baseline and year 3

Secondary Outcomes (4)

• Intra-plaque hemorrhage (IPH)

  At baseline and year 3

• Intra-plaque lipid (lipid-rich necrotic core)

  baseline and year 3

• blood pressure and pulse rate

  At months 0, 3, 6, 12, 18, 24, 30, 36

• initiation of statin therapy

  baseline and year 3

Other Outcomes (7)

• LDL-cholesterol

  At months, 0, 3, 6, 12, 18, 24, 30, 36

• HDL-cholesterol

  months 0, 3, 6, 12, 18, 24, 30, 36

• C-reactive protein (CRP)

  At months 0, 12, 24, and 36

Study Arms (2)

Portfolio Plus Diet

EXPERIMENTAL

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

DASH-like (high fibre) diet

ACTIVE COMPARATOR

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

Interventions

Portfolio Plus Diet 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)

Also known as: Dietary Portfolio of cholesterol-lowering foods, Enhanced portfolio, Portfolio eating plan

Portfolio Plus Diet

DASH-like (high fibre) dietary advice 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

Also known as: high fibre diet

DASH-like (high fibre) diet

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible participants will be:
• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• University of Toronto: collaborator
• Laval University: collaborator
• University of Manitoba: collaborator
• University of British Columbia: collaborator

Study Sites (4)

Healthy Heart Lipid Clinic, St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

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

Winnipeg, Manitoba, R3T 6C5, Canada

Location

Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

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

Québec, Quebec, G1V 4G2, Canada

Location

Related Publications (39)

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MeSH Terms

Conditions

Cardiovascular Diseases; Hypercholesterolemia; Diabetes Mellitus; Metabolic Syndrome; Obesity

Interventions

Diet; Nutrition Assessment

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• David J Jenkins, MD

  St. Michael's Hospital / University of Toronto

  PRINCIPAL INVESTIGATOR

• Benoit Lamarche, PhD

  Laval University

  STUDY DIRECTOR

• Peter Jones, PhD

  University of Manitoba

  STUDY DIRECTOR

• Jiri Frohlich, MD

  University of British Columbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: March 5, 2014
• Primary Completion: October 7, 2014
• Study Completion: October 7, 2014
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

CA (4)