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Clinical Trial Details — Status: Withdrawn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Status Withdrawn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
Health authority
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

Study Design


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, 

References & Publications (39)

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Jenkins DJ, Kendall CW, Faulkner DA, Nguyen T, Kemp T, Marchie A, Wong JM, de Souza R, Emam A, Vidgen E, Trautwein EA, Lapsley KG, Holmes C, Josse RG, Leiter LA, Connelly PW, Singer W. Assessment of the longer-term effects of a dietary portfolio of cholesterol-lowering foods in hypercholesterolemia. Am J Clin Nutr. 2006 Mar;83(3):582-91. — View Citation

Jenkins DJ, Kendall CW, Marchie A, Faulkner D, Vidgen E, Lapsley KG, Trautwein EA, Parker TL, Josse RG, Leiter LA, Connelly PW. The effect of combining plant sterols, soy protein, viscous fibers, and almonds in treating hypercholesterolemia. Metabolism. 2003 Nov;52(11):1478-83. — View Citation

Jenkins 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. — View Citation

Jenkins 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. — View Citation

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Keys A, Aravanis C, Blackburn HW, Van Buchem FS, Buzina R, Djordjevic BD, Dontas AS, Fidanza F, Karvonen MJ, Kimura N, Lekos D, Monti M, Puddu V, Taylor HL. Epidemiological studies related to coronary heart disease: characteristics of men aged 40-59 in seven countries. Acta Med Scand Suppl. 1966;460:1-392. — View Citation

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Mathiesen EB, Johnsen SH, Wilsgaard T, Bønaa KH, Løchen ML, Njølstad I. Carotid plaque area and intima-media thickness in prediction of first-ever ischemic stroke: a 10-year follow-up of 6584 men and women: the Tromsø Study. Stroke. 2011 Apr;42(4):972-8. doi: 10.1161/STROKEAHA.110.589754. Epub 2011 Feb 10. — View Citation

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Saam T, Kerwin WS, Chu B, Cai J, Kampschulte A, Hatsukami TS, Zhao XQ, Polissar NL, Neradilek B, Yarnykh VL, Flemming K, Huston J 3rd, Insull W Jr, Morrisett JD, Rand SD, DeMarco KJ, Yuan C. Sample size calculation for clinical trials using magnetic resonance imaging for the quantitative assessment of carotid atherosclerosis. J Cardiovasc Magn Reson. 2005;7(5):799-808. — View Citation

Shai I, Schwarzfuchs D, Henkin Y, Shahar DR, Witkow S, Greenberg I, Golan R, Fraser D, Bolotin A, Vardi H, Tangi-Rozental O, Zuk-Ramot R, Sarusi B, Brickner D, Schwartz Z, Sheiner E, Marko R, Katorza E, Thiery J, Fiedler GM, Blüher M, Stumvoll M, Stampfer MJ; Dietary Intervention Randomized Controlled Trial (DIRECT) Group.. Weight loss with a low-carbohydrate, Mediterranean, or low-fat diet. N Engl J Med. 2008 Jul 17;359(3):229-41. doi: 10.1056/NEJMoa0708681. Erratum in: N Engl J Med. 2009 Dec 31;361(27):2681. — View Citation

Smilde TJ, van Wissen S, Wollersheim H, Kastelein JJ, Stalenhoef AF. Genetic and metabolic factors predicting risk of cardiovascular disease in familial hypercholesterolemia. Neth J Med. 2001 Oct;59(4):184-95. Review. — View Citation

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Touboul PJ, Hennerici MG, Meairs S, Adams H, Amarenco P, Desvarieux M, Ebrahim S, Fatar M, Hernandez Hernandez R, Kownator S, Prati P, Rundek T, Taylor A, Bornstein N, Csiba L, Vicaut E, Woo KS, Zannad F; Advisory Board of the 3rd Watching the Risk Symposium 2004, 13th European Stroke Conference.. Mannheim intima-media thickness consensus. Cerebrovasc Dis. 2004;18(4):346-9. Epub 2004 Nov 2. Review. — View Citation

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* Note: There are 39 references in allClick 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
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