The Combined Portfolio Diet and Exercise Study

NCT02481466 | Completed DMC

• 3 other identifiers: REB # 14-316FRN 130278FRN 129920
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to determine whether a dietary portfolio of cholesterol-lowering foods (viscous fibres, soy protein, plant sterols and nuts) further enhanced by increased levels of monounsaturated fatty acids (MUFA) and low glycemic index foods; together with a structured exercise program reduce the progression of carotid and coronary atheromatous lesions, Low density lipoprotein-cholesterol (LDL-C), and blood pressure, while reducing the number of individuals requiring statins.

Conditions

Cardiovascular Diseases; Hypercholesterolemia; Type 2 Diabetes; Metabolic Syndrome

Keywords

Arterial plaque; Magnetic resonance imaging (MRI); Portfolio diet; Dietary modification; Dietary trials; hypercholesterolemia; diabetes; exercise; cardiovascular disease risk; glycemic index (GI); Carotid Ultrasound; Dietary Approaches to Stop Hypertension (DASH) diet

Outcome Measures

Primary Outcomes (1)

• Change from baseline of the maximum vessel wall volume of the carotid arteries by MRI at year 1 and 3

  MRI imaging assessment of the carotid arteries will be done at baseline, end of year 1 and year 3.

  At months 0, 12 and 36

Secondary Outcomes (7)

• Coronary atheroma in the large vessels by MRI at year 1 and 3

  At months 0, 12 and 36

• Lipid rich necrotic core by MRI at year 1 and 3

  At months 0, 12 and 36

• intra plaque hemorrhage by MRI at year 1 and 3

  At months 0, 12 and 36

• Blood pressure and pulse rate

  At months 0, 12 and 36

• Treatment difference in initiation of statin therapy

  At month 12 and 36

Other Outcomes (21)

• Completeness of clinic attendance and data collection and provision of fasting blood samples for planned tests.

  At months -3, -0.5, and then at months 0, 3, 6, 9,12, 15, 18, 21, 24, 27, 30, 33 and 36

• Serum lipids: total cholesterol, LDL-chol, HDL-chol, and Triglycerides

  At months -3, -0.5, and then at months 0, 3, 6, 9,12, 15, 18, 21, 24, 27, 30, 33 and 36

• Hemoglobin A1c

  At months -3, -0.5, 0, 3, 6, 9,12, 15, 18, 21, 24, 27, 30, 33 and 36

Study Arms (4)

Portfolio diet and structured exercise

EXPERIMENTAL

Participants will receive advice on a therapeutic diet appropriate for hypercholesterolemia (ie \<7% of energy from saturated fat, \<200mg/d cholesterol) PLUS the combination of viscous fibres, soy protein, plant sterols and nuts, 5% extra monounsaturated fat, and selection of low glycemic index foods and be instructed on a standardized physical activity/exercise component supervised by kinesiologists.

Behavioral: Portfolio diet and structured exercise

DASH-like diet and structured exercise

ACTIVE COMPARATOR

Participants will receive advice to follow a DASH-like diet of whole grains, and low-fat dairy products with fruits and vegetables and a be instructed on the Laval exercise program-a standardized physical activity/exercise component supervised by trained kinesiologists (exercise physiologists).

Behavioral: DASH-like diet and structured exercise

Portfolio diet and routine exercise

EXPERIMENTAL

Participants will receive advice that will conform to the current therapeutic diet appropriate for hypercholesterolemia (ie \<7% of energy from saturated fat, \<200mg/d cholesterol) PLUS the combination of viscous fibres, soy protein, plant sterols and nuts, 5% extra monounsaturated fat, and selection of low glycemic index foods and will be provided with a copy of Health Canada Physical Activity Guidelines with advice to increase physical activity.

Behavioral: Portfolio diet and routine exercise

DASH-like diet and routine exercise

ACTIVE COMPARATOR

Participants will receive advice to follow a DASH-like diet of whole grains, and low-fat dairy products with fruits and vegetables and will be provided with a copy of Health Canada Physical Activity Guidelines with advice to increase physical activity.

Behavioral: DASH-like diet and routine exercise

Interventions

Portfolio diet and structured exercise BEHAVIORAL

Diet: Foods will contribute 9 g/1000 kcal viscous fibre as β-glucan (oats, barley and oat bran breads) and psyllium (cereal), 1 g plant sterol/1000 kcal diet (in sterol margarine), 22.5 g soy protein/1000 kcal (soy burgers and other soy meat analogues, soy milks, yogurts and cheese) and 22.5 g nuts/1000 kcal and increased MUFA (as olive and canola oils, avocados, nuts etc.). The glycemic index will be reduced from 83 to 70 GI units (bread scale). Exercise: A program encouraging 150 minutes of exercise, based on the Quebec Heart and Lung Institute exercise program. A short submaximal treadmill test will be used to assess cardiorespiratory fitness. A kinesiologist will work with participants using behavioral strategies to achieve the target of 150 min/week of physical activity or exercise in 3 or 5 sessions weekly (vigorous, moderate or mild depending on goals and tolerance). The target goal will be at least 10,000 steps daily.

Also known as: Dietary Portfolio of cholesterol-lowering foods, Enhanced portfolio, Low Glycemic Index Portfolio, Portfolio Plus diet, Laval exercise program, structured exercise program, Portfolio diet, structured exercise

Portfolio diet and structured exercise

DASH-like diet and structured exercise BEHAVIORAL

Diet: Participants will be encouraged to follow a diet of whole grain foods (brown rice, whole wheat breads, muffins and breakfast cereals), reduce meat consumption, choose low fat dairy foods and a control margarine. Exercise: A physical activity/exercise program encouraging 150 minutes of exercise, based on the exercise program developed at the Quebec Heart and Lung Institute. A short submaximal treadmill test will be used to assess cardiorespiratory fitness. A kinesiologist will work with participants using behavioral strategies to develop and support a plan that aims to achieve the target of 150 min/week of physical activity or exercise in 3 or 5 sessions weekly (vigorous, moderate or mild depending of goals and tolerance) in keeping with maximum achievable goals of participants. The target goal will be at least 10,000 steps daily recorded on their pedometers.

Also known as: Modified DASH diet, high fibre diet, structured exercise program, DASH-like diet, Laval exercise program

DASH-like diet and structured exercise

Portfolio diet and routine exercise BEHAVIORAL

Diet: Foods on the dietary portfolio plan will contribute 9 g/1000 kcal viscous fibre as β-glucan (oats, barley and oat bran breads) and psyllium (cereal), 1 g plant sterol/1000 kcal diet (in sterol margarine), 22.5 g soy protein/1000 kcal (soy burgers and other soy meat analogues, soy milks, yogurts and cheese) and 22.5 g peanuts or equivalent of tree nuts/1000 kcal (Table 1A) and increased MUFA (as olive and canola oils, avocados, nuts etc.). The glycemic index will be reduced from 83 to 70 GI units (bread scale). Exercise: Participants in this group will receive standard of care for individuals being seen by a general practitioner. They will be advised to achieve the current recommended targets for daily physical activity and educational material published by Health Canada (Canada's Physical Activity Guide, Health Canada). They will undergo treadmill tests at the start and end of each 1 year period. They will not receive the more frequent, targeted visits with a kinesiologist.

Also known as: Dietary Portfolio of cholesterol-lowering foods, Enhanced portfolio, Low Glycemic Index Portfolio, Portfolio Plus diet, routine exercise

Portfolio diet and routine exercise

DASH-like diet and routine exercise BEHAVIORAL

Diet: Participants will be encouraged to follow a diet of whole grain foods (brown rice, whole wheat breads, muffins and breakfast cereals), reduce meat consumption, choose low fat dairy foods and a control margarine. Exercise: Participants in this group will receive standard of care for individuals being seen by a general practitioner. They will be advised to achieve the current recommended targets for daily physical activity and educational material published by Health Canada (Canada's Physical Activity Guide, Health Canada). They will undergo treadmill tests at the start and end of each 1 year period. They will not receive the more frequent, targeted visits with a kinesiologist.

Also known as: Modified DASH diet, high fibre diet, routine exercise

DASH-like diet and routine exercise

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
• men over 21 years
• post-menopausal women
• Having a BMI less than or equal to 40 kg/m2 and who have measurable arterial thickening (\>/=1.2mm) at screening as assessed by ultrasound.
• They will include those who have at least 1 of the following characteristics:
• Type 2 diabetes
• Non-diabetic subjects post MI or post percutaneous coronary intervention (angioplasty) on statin therapy;
• Hyper-cholesterolemic and treated with statins or have been prescribed statins but are not taking it because they are either unable (intolerant) or unwilling to take statin drugs.
• Raised blood pressure, \>140/90 (untreated)

You may not qualify if:

• Individuals with the following conditions will be excluded:
• cardiovascular disease that precludes exercise e.g.
• recent stroke or
• recent myocardial infarction or
• cardiac condition that severely compromises normal function:
• mitral valve disease, atrial fibrillation and individuals with Implantable Cardioverter Defibrillator (ICD)
• heart failure--grades 2-4 (based on New York Heart Association classification),
• severe angina sufficient to prevent any form of physical activity
• other conditions preventing exercise.
• secondary causes of hypercholesterolemia e.g. hypothyroidism (unless treated and on a stable dose of L-thyroxin), clinically significant renal (that precludes dietary change) or liver disease .
• LDL-cholesterol \<1.4mmol/L
• uncontrolled blood pressure
• major disability
• disorder requiring continuous medical attention (on Coumadin) and treatment, such as:
• chronic heart failure

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 Centre for Functional Foods and Nutraceuticals, 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, Laval University

Québec, Quebec, G1V 4G2, Canada

Location

Related Publications (19)

• Krauss 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.

  PMID: 11056107 BACKGROUND

• Anderson TJ, Gregoire J, Hegele RA, Couture P, Mancini GB, McPherson R, Francis GA, Poirier P, Lau DC, Grover S, Genest J Jr, Carpentier AC, Dufour R, Gupta M, Ward R, Leiter LA, Lonn E, Ng DS, Pearson GJ, Yates GM, Stone JA, Ur E. 2012 update of the Canadian Cardiovascular Society guidelines for the diagnosis and treatment of dyslipidemia for the prevention of cardiovascular disease in the adult. Can J Cardiol. 2013 Feb;29(2):151-67. doi: 10.1016/j.cjca.2012.11.032.

  PMID: 23351925 BACKGROUND

• 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.

  PMID: 9863851 BACKGROUND

• Jenkins 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.

  PMID: 21041432 BACKGROUND

• 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.

  PMID: 19088352 BACKGROUND

• Jenkins 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.

  PMID: 23089999 BACKGROUND

• Jenkins DJ, Kendall CW, Faulkner D, Vidgen E, Trautwein EA, Parker TL, Marchie A, Koumbridis G, Lapsley KG, Josse RG, Leiter LA, Connelly PW. A dietary portfolio approach to cholesterol reduction: combined effects of plant sterols, vegetable proteins, and viscous fibers in hypercholesterolemia. Metabolism. 2002 Dec;51(12):1596-604. doi: 10.1053/meta.2002.35578.

  PMID: 12489074 BACKGROUND

• Borel AL, Nazare JA, Smith J, Almeras N, Tremblay A, Bergeron J, Poirier P, Despres JP. Visceral and not subcutaneous abdominal adiposity reduction drives the benefits of a 1-year lifestyle modification program. Obesity (Silver Spring). 2012 Jun;20(6):1223-33. doi: 10.1038/oby.2011.396. Epub 2012 Jan 19.

  PMID: 22262155 BACKGROUND

• Borel AL, Nazare JA, Smith J, Almeras N, Tremblay A, Bergeron J, Poirier P, Despres JP. Improvement in insulin sensitivity following a 1-year lifestyle intervention program in viscerally obese men: contribution of abdominal adiposity. Metabolism. 2012 Feb;61(2):262-72. doi: 10.1016/j.metabol.2011.06.024. Epub 2011 Aug 23.

  PMID: 21864868 BACKGROUND

• Pelletier-Beaumont E, Arsenault BJ, Almeras N, Bergeron J, Tremblay A, Poirier P, Despres JP. Normalization of visceral adiposity is required to normalize plasma apolipoprotein B levels in response to a healthy eating/physical activity lifestyle modification program in viscerally obese men. Atherosclerosis. 2012 Apr;221(2):577-82. doi: 10.1016/j.atherosclerosis.2012.01.023. Epub 2012 Jan 20.

  PMID: 22321874 BACKGROUND

• Liu S, Willett WC, Stampfer MJ, Hu FB, Franz M, Sampson L, Hennekens CH, Manson JE. A prospective study of dietary glycemic load, carbohydrate intake, and risk of coronary heart disease in US women. Am J Clin Nutr. 2000 Jun;71(6):1455-61. doi: 10.1093/ajcn/71.6.1455.

  PMID: 10837285 BACKGROUND

• Pereira MA, O'Reilly E, Augustsson K, Fraser GE, Goldbourt U, Heitmann BL, Hallmans G, Knekt P, Liu S, Pietinen P, Spiegelman D, Stevens J, Virtamo J, Willett WC, Ascherio A. Dietary fiber and risk of coronary heart disease: a pooled analysis of cohort studies. Arch Intern Med. 2004 Feb 23;164(4):370-6. doi: 10.1001/archinte.164.4.370.

  PMID: 14980987 BACKGROUND

• 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. No abstract available.

  PMID: 5226858 BACKGROUND

• 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, Bluher 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.

  PMID: 18635428 BACKGROUND

• 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. doi: 10.1159/000081812. Epub 2004 Nov 2.

  PMID: 15523176 BACKGROUND

• 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. doi: 10.1093/ajcn.83.3.582.

  PMID: 16522904 BACKGROUND

• The DASH diet. Dietary Approaches to Stop Hypertension. Lippincotts Prim Care Pract. 1998 Sep-Oct;2(5):536-8. No abstract available.

  PMID: 9791393 BACKGROUND

• Murie-Fernandez M, Irimia P, Toledo E, Martinez-Vila E, Buil-Cosiales P, Serrano-Martinez M, Ruiz-Gutierrez V, Ros E, Estruch R, Martinez-Gonzalez MA; PREDIMED Investigators. Carotid intima-media thickness changes with Mediterranean diet: a randomized trial (PREDIMED-Navarra). Atherosclerosis. 2011 Nov;219(1):158-62. doi: 10.1016/j.atherosclerosis.2011.06.050. Epub 2011 Jul 6.

  PMID: 21802081 BACKGROUND

• Kavanagh ME, Chiavaroli L, Quibrantar SM, Viscardi G, Ramboanga K, Amlin N, Paquette M, Sahye-Pudaruth S, Patel D, Grant SM, Glenn AJ, Ayoub-Charette S, Zurbau A, Josse RG, Malik VS, Kendall CWC, Jenkins DJA, Sievenpiper JL. Acceptability of a Web-Based Health App (PortfolioDiet.app) to Translate a Nutrition Therapy for Cardiovascular Disease in High-Risk Adults: Mixed Methods Randomized Ancillary Pilot Study. JMIR Cardio. 2025 Mar 28;9:e58124. doi: 10.2196/58124.

  PMID: 40152922 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Hypercholesterolemia; Diabetes Mellitus, Type 2; Metabolic Syndrome; Diabetes Mellitus; Motor Activity

Interventions

Diet

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• David Jenkins, MD

  Risk Factor Modification Centre, St. Michael's Hospital

  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: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a 2 x 2 factorial design

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: June 25, 2015
• Study Start: November 25, 2016
• Primary Completion: June 13, 2023
• Study Completion: June 23, 2023
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

CA (4)