Magnetic Resonance Imaging-Portfolio Diet Study #7

Obesity Clinical Trial

— MRIPD#7  

Official title:

The Canada-wide Human Nutrition Trialists' Network

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02078635
• Other study ID #: REB 13-260
• Secondary ID: FRN 129920
• Status: Withdrawn
• Phase: N/A
• First received: February 18, 2014
• Last updated: April 25, 2017
• Est. completion date: October 7, 2014

Study information

• Verified date: April 2017
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 7, 2014
• Est. primary completion date: October 7, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes
• Hypercholesterolemia
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Intervention

Behavioral:
• Portfolio Plus Diet
Foods on the Portfolio Plus plan will contribute 9 g/1000 kcal viscous fibre as ß-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) 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

Locations

Country	Name	City	State
Canada	Institute of Nutraceuticals and Functional Foods and the Quebec Heart and Lung Institute, Laval University	Quebec City	Quebec
Canada	Risk Factor Modification Centre, St. Michael's Hospital	Toronto	Ontario
Canada	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

Sponsors (6)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Canadian Institutes of Health Research (CIHR), Laval University, University of British Columbia, University of Manitoba, University of Toronto

Country where clinical trial is conducted

Canada, 

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	LDL-cholesterol		At months, 0, 3, 6, 12, 18, 24, 30, 36
Other	HDL-cholesterol		months 0, 3, 6, 12, 18, 24, 30, 36
Other	C-reactive protein (CRP)		At months 0, 12, 24, and 36
Other	The Medical Outcomes Study 36-Item Short Form Questionnaire (SF-36)	Survey on quality of life.	Months 0 and 36
Other	Genetic whole genome testing	One time sample collection of buffy coat white cells for future analysis	month 0
Other	satiety of the test and control diet	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
Other	Palatability of the test / control diets	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
Primary	Change from baseline of the maximum vessel wall volume of the carotid arteries	Assessed by MRI	At baseline and year 3
Secondary	Intra-plaque hemorrhage (IPH)	Assessed by MRI	At baseline and year 3
Secondary	Intra-plaque lipid (lipid-rich necrotic core)	Assessed by MRI	baseline and year 3
Secondary	blood pressure and pulse rate		At months 0, 3, 6, 12, 18, 24, 30, 36
Secondary	initiation of statin therapy	According to current CCS guidelines	baseline and year 3