Cardiovascular DiseasesMRIPD#7NCT02078635
Magnetic Resonance Imaging-Portfolio Diet Study #7
A study testing Portfolio Plus Diet and DASH-like (high fibre) dietary advice in people with Cardiovascular Diseases and Hypercholesterolemia, run by Unity Health Toronto at 4 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cardiovascular Diseases, Hypercholesterolemia, Diabetes
- What is being tested?
- Portfolio Plus Diet and DASH-like (high fibre) dietary advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesCanada
- Study dates
- Start not givento 7 Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- Individuals with the following conditions will be excluded:
- major cardiovascular event
- stroke or
- myocardial infarction
- Cardiac conditions that compromise normal function
- mitral valve disease
Show all 27Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Institute of Nutraceuticals and Functional Foods and the Quebec Heart and Lung Institute, Laval University
Québec, Quebec, G1V 4G2
Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, M5C 2T2
Healthy Heart Lipid Clinic, St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Richardson Center for Functional Foods and Nutraceuticals and the St. Boniface Hospital Cardiovascular Center, University of Manitoba
Winnipeg, Manitoba, R3T 6C5
About this study
Official title: 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?
Read the 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.
- Being tested
- Portfolio Plus Diet, DASH-like (high fibre) dietary advice
- Keywords
- Arterial plaque, portfolio diet, dietary modification, dietary trials, Canadian Network, knowledge synthesis and translation, Magnetic resonance imaging
- Medical subject headings
- Cardiovascular Diseases, Hypercholesterolemia, Diabetes Mellitus, Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portfolio Plus DietBehavioural
Also called Dietary Portfolio of cholesterol-lowering foods, Enhanced portfolio, Portfolio eating plan
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) dietary adviceBehavioural
Also called high fibre diet
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Behavioral: DASH-like (high fibre) dietary advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of the maximum vessel wall volume of the carotid arteries
Assessed by MRI
Measured: At baseline and year 3
Secondary outcomes (4)
Intra-plaque hemorrhage (IPH)
Assessed by MRI
Measured: At baseline and year 3
Intra-plaque lipid (lipid-rich necrotic core)
Assessed by MRI
Measured: baseline and year 3
blood pressure and pulse rate
Measured: At months 0, 3, 6, 12, 18, 24, 30, 36
initiation of statin therapy
According to current CCS guidelines
Measured: baseline and year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Primary completion7 Oct 2014
- Study completion7 Oct 2014
Why it stopped: Study was amalgamated with another study to include exercise as another intervention.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Toronto, Laval University, University of Manitoba, University of British Columbia
- Responsible party
- Sponsor
- Investigators
- David J Jenkins, MD, Principal investigator, St. Michael's Hospital / University of TorontoBenoit Lamarche, PhD, Study director, Laval UniversityPeter Jones, PhD, Study director, University of ManitobaJiri Frohlich, MD, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078635
- Sponsor's protocol ID
- REB 13-260
- Other IDs
- FRN 129920
- Acronym
- MRIPD#7
- Status last verified
- Apr 2017
- First submitted
- 18 Feb 2014
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Jenkins DJ, Jones PJ, Lamarche B, Kendall CW, Faulkner D, Cermakova L, Gigleux I, Ramprasath V, de Souza R, Ireland C, Patel D, Srichaikul K, Abdulnour S, Bashyam B, Collier C, Hoshizaki S, Josse RG, Leiter LA, Connelly PW, Frohlich J. Effect of a dietary portfolio of cholesterol-lowering foods given at 2 levels of intensity of dietary advice on serum lipids in hyperlipidemia: a randomized controlled trial. JAMA. 2011 Aug 24;306(8):831-9. doi: 10.1001/jama.2011.1202.
PubMed 21862744Statistics Canada. Mortality, Summary list of Causes 2008. Released October 18, 2011
Conference Board of Canada. The Canadian Heart Healthy Strategy: Risk Factors and Future Cost Implications. Report of February 2010.
Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001 May 16;285(19):2486-97. doi: 10.1001/jama.285.19.2486. No abstract available.
PubMed 11368702Krauss RM, Eckel RH, Howard B, Appel LJ, Daniels SR, Deckelbaum RJ, Erdman JW Jr, Kris-Etherton P, Goldberg IJ, Kotchen TA, Lichtenstein AH, Mitch WE, Mullis R, Robinson K, Wylie-Rosett J, St Jeor S, Suttie J, Tribble DL, Bazzarre TL. AHA Dietary Guidelines: revision 2000: A statement for healthcare professionals from the Nutrition Committee of the American Heart Association. Circulation. 2000 Oct 31;102(18):2284-99. doi: 10.1161/01.cir.102.18.2284. No abstract available.
PubMed 11056107Genest J, McPherson R, Frohlich J, Anderson T, Campbell N, Carpentier A, Couture P, Dufour R, Fodor G, Francis GA, Grover S, Gupta M, Hegele RA, Lau DC, Leiter L, Lewis GF, Lonn E, Mancini GB, Ng D, Pearson GJ, Sniderman A, Stone JA, Ur E. 2009 Canadian Cardiovascular Society/Canadian guidelines for the diagnosis and treatment of dyslipidemia and prevention of cardiovascular disease in the adult - 2009 recommendations. Can J Cardiol. 2009 Oct;25(10):567-79. doi: 10.1016/s0828-282x(09)70715-9.
PubMed 19812802Ornish D, Brown SE, Scherwitz LW, Billings JH, Armstrong WT, Ports TA, McLanahan SM, Kirkeeide RL, Brand RJ, Gould KL. Can lifestyle changes reverse coronary heart disease? The Lifestyle Heart Trial. Lancet. 1990 Jul 21;336(8708):129-33. doi: 10.1016/0140-6736(90)91656-u.
PubMed 1973470Atkins R. Dr. Atkins' New Diet Revolution. New York NAB.
Ornish D, Scherwitz LW, Billings JH, Brown SE, Gould KL, Merritt TA, Sparler S, Armstrong WT, Ports TA, Kirkeeide RL, Hogeboom C, Brand RJ. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998 Dec 16;280(23):2001-7. doi: 10.1001/jama.280.23.2001.
PubMed 9863851Jenkins DJ, Chiavaroli L, Wong JM, Kendall C, Lewis GF, Vidgen E, Connelly PW, Leiter LA, Josse RG, Lamarche B. Adding monounsaturated fatty acids to a dietary portfolio of cholesterol-lowering foods in hypercholesterolemia. CMAJ. 2010 Dec 14;182(18):1961-7. doi: 10.1503/cmaj.092128. Epub 2010 Nov 1.
PubMed 21041432Food labeling: health claims; plant sterol/stanol esters and coronary heart disease. Food and Drug Administration, HHS. Interim final rule. Fed Regist. 2000 Sep 8;65(175):54686-739.
PubMed 11503640Jenkins DJ, Kendall CW, McKeown-Eyssen G, Josse RG, Silverberg J, Booth GL, Vidgen E, Josse AR, Nguyen TH, Corrigan S, Banach MS, Ares S, Mitchell S, Emam A, Augustin LS, Parker TL, Leiter LA. Effect of a low-glycemic index or a high-cereal fiber diet on type 2 diabetes: a randomized trial. JAMA. 2008 Dec 17;300(23):2742-53. doi: 10.1001/jama.2008.808.
PubMed 19088352Jenkins DJ, Kendall CW, Augustin LS, Mitchell S, Sahye-Pudaruth S, Blanco Mejia S, Chiavaroli L, Mirrahimi A, Ireland C, Bashyam B, Vidgen E, de Souza RJ, Sievenpiper JL, Coveney J, Leiter LA, Josse RG. Effect of legumes as part of a low glycemic index diet on glycemic control and cardiovascular risk factors in type 2 diabetes mellitus: a randomized controlled trial. Arch Intern Med. 2012 Nov 26;172(21):1653-60. doi: 10.1001/2013.jamainternmed.70.
PubMed 23089999Jones PJ, AbuMweis SS. Phytosterols as functional food ingredients: linkages to cardiovascular disease and cancer. Curr Opin Clin Nutr Metab Care. 2009 Mar;12(2):147-51. doi: 10.1097/mco.0b013e328326770f.
PubMed 19209468Jenkins DJ, Kendall CW, Marchie A, Faulkner DA, Wong JM, de Souza R, Emam A, Parker TL, Vidgen E, Lapsley KG, Trautwein EA, Josse RG, Leiter LA, Connelly PW. Effects of a dietary portfolio of cholesterol-lowering foods vs lovastatin on serum lipids and C-reactive protein. JAMA. 2003 Jul 23;290(4):502-10. doi: 10.1001/jama.290.4.502.
PubMed 12876093
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Canada-wide Human Nutrition Trialists' Network
- ClinicalTrials.gov ID
- NCT02078635
- Acronym / sponsor ID
- MRIPD#7 / REB 13-260
- Keywords
- Arterial plaque, portfolio diet, dietary modification, dietary trials, Canadian Network, knowledge synthesis and translation, Magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was amalgamated with another study to include exercise as another intervention.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Toronto, Laval University, University of Manitoba, University of British Columbia
- Primary completion
- 7 Oct 2014 (actual)
- Study completion
- 7 Oct 2014 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Portfolio Plus Diet | Experimental | Behavioral: Portfolio Plus DietParticipants 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) |
| DASH-like (high fibre) diet | Active comparator | Behavioral: DASH-like (high fibre) dietary adviceThe 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) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- 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:
Key exclusion criteria (27 listed)
- major cardiovascular event
- Cardiac conditions that compromise normal function
- familial hypercholesterolemia
- secondary causes of hypercholesterolemia
- diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portfolio Plus DietAlso: Dietary Portfolio of cholesterol-lowering foods, Enhanced portfolio, Portfolio eating planFoods 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) | Behavioural | Portfolio Plus Diet |
| DASH-like (high fibre) dietary adviceAlso: high fibre dietDietary 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 | Behavioural | DASH-like (high fibre) diet |
Primary outcome
Change from baseline of the maximum vessel wall volume of the carotid arteries
Time frame: At baseline and year 3
Assessed by MRI
4 secondary outcomes
Intra-plaque hemorrhage (IPH)
Time frame: At baseline and year 3
Intra-plaque lipid (lipid-rich necrotic core)
Time frame: baseline and year 3
blood pressure and pulse rate
Time frame: At months 0, 3, 6, 12, 18, 24, 30, 36
initiation of statin therapy
Time frame: baseline and year 3
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Background: PubMed 21862744Jenkins DJ, Jones PJ, Lamarche B, Kendall CW, Faulkner D, Cermakova L, Gigleux I, Ramprasath V, de Souza R, Ireland C, Patel D, Srichaikul K, Abdulnour S, Bashyam B, Collier C, Hoshizaki S, Josse RG, Leiter LA, Connelly PW, Frohlich J. Effect of a dietary portfolio of cholesterol-lowering foods given at 2 levels of intensity of dietary advice on serum lipids in hyperlipidemia: a randomized controlled trial. JAMA. 2011 Aug 24;306(8):831-9. doi: 10.1001/jama.2011.1202.
- BackgroundStatistics Canada. Mortality, Summary list of Causes 2008. Released October 18, 2011
- BackgroundConference Board of Canada. The Canadian Heart Healthy Strategy: Risk Factors and Future Cost Implications. Report of February 2010.
- Background: PubMed 11368702Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001 May 16;285(19):2486-97. doi: 10.1001/jama.285.19.2486. No abstract available.
- Background: PubMed 11056107Krauss RM, Eckel RH, Howard B, Appel LJ, Daniels SR, Deckelbaum RJ, Erdman JW Jr, Kris-Etherton P, Goldberg IJ, Kotchen TA, Lichtenstein AH, Mitch WE, Mullis R, Robinson K, Wylie-Rosett J, St Jeor S, Suttie J, Tribble DL, Bazzarre TL. AHA Dietary Guidelines: revision 2000: A statement for healthcare professionals from the Nutrition Committee of the American Heart Association. Circulation. 2000 Oct 31;102(18):2284-99. doi: 10.1161/01.cir.102.18.2284. No abstract available.
- Background: PubMed 19812802Genest J, McPherson R, Frohlich J, Anderson T, Campbell N, Carpentier A, Couture P, Dufour R, Fodor G, Francis GA, Grover S, Gupta M, Hegele RA, Lau DC, Leiter L, Lewis GF, Lonn E, Mancini GB, Ng D, Pearson GJ, Sniderman A, Stone JA, Ur E. 2009 Canadian Cardiovascular Society/Canadian guidelines for the diagnosis and treatment of dyslipidemia and prevention of cardiovascular disease in the adult - 2009 recommendations. Can J Cardiol. 2009 Oct;25(10):567-79. doi: 10.1016/s0828-282x(09)70715-9.
- Background: PubMed 1973470Ornish D, Brown SE, Scherwitz LW, Billings JH, Armstrong WT, Ports TA, McLanahan SM, Kirkeeide RL, Brand RJ, Gould KL. Can lifestyle changes reverse coronary heart disease? The Lifestyle Heart Trial. Lancet. 1990 Jul 21;336(8708):129-33. doi: 10.1016/0140-6736(90)91656-u.
- BackgroundAtkins R. Dr. Atkins' New Diet Revolution. New York NAB.
- Background: PubMed 9863851Ornish D, Scherwitz LW, Billings JH, Brown SE, Gould KL, Merritt TA, Sparler S, Armstrong WT, Ports TA, Kirkeeide RL, Hogeboom C, Brand RJ. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998 Dec 16;280(23):2001-7. doi: 10.1001/jama.280.23.2001.
- Background: PubMed 21041432Jenkins DJ, Chiavaroli L, Wong JM, Kendall C, Lewis GF, Vidgen E, Connelly PW, Leiter LA, Josse RG, Lamarche B. Adding monounsaturated fatty acids to a dietary portfolio of cholesterol-lowering foods in hypercholesterolemia. CMAJ. 2010 Dec 14;182(18):1961-7. doi: 10.1503/cmaj.092128. Epub 2010 Nov 1.
- Background: PubMed 11503640Food labeling: health claims; plant sterol/stanol esters and coronary heart disease. Food and Drug Administration, HHS. Interim final rule. Fed Regist. 2000 Sep 8;65(175):54686-739.
- Background: PubMed 19088352Jenkins DJ, Kendall CW, McKeown-Eyssen G, Josse RG, Silverberg J, Booth GL, Vidgen E, Josse AR, Nguyen TH, Corrigan S, Banach MS, Ares S, Mitchell S, Emam A, Augustin LS, Parker TL, Leiter LA. Effect of a low-glycemic index or a high-cereal fiber diet on type 2 diabetes: a randomized trial. JAMA. 2008 Dec 17;300(23):2742-53. doi: 10.1001/jama.2008.808.
Related trials for Cardiovascular Diseases
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J Jenkins, MD principal investigator
St. Michael's Hospital / University of Toronto
Benoit Lamarche, PhD study director
Laval University
Peter Jones, PhD study director
University of Manitoba
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portfolio Plus Diet and DASH-like (high fibre) dietary advice in people with Cardiovascular Diseases and Hypercholesterolemia, run by Unity Health Toronto at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of the maximum vessel wall volume of the carotid arteries (time frame: At baseline and year 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02078635, which also lists 39 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.