Enhanced Multicenter Dietary Portfolio Study

NCT01954472 | Withdrawn

• 2 other identifiers: REB 13-188FRN 130278
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

"Is it possible to recruit and retain up to 200 participants in a Randomize Control Trial (RCT) of high impact lifestyle approach of diet and exercise designed to significantly reduce cardiovascular events in middle-aged and older men and women at high risk of such events?" To address this question, we propose a pilot study of 3 years in duration: 1 year recruitment and randomization, a full year of intervention for all recruited participants, and the last 6 months to assess the one year data and prepare and submit the full trial application, informed by the pilot study outcomes in terms of retention rate. The pilot will then continue on for the full 9 years of intervention and be rolled into the main study involving additional Canadian centers and collaborating international centers in the US, Britain, Europe, Australia, New Zealand, India, and South Africa.

Conditions

Cardiovascular Diseases; Type 2 Diabetes; Hypercholesterolemia

Keywords

Portfolio diet; dietary modification; hypercholesterolemia; diabetes; Exercise; CVD risk; glycemic index; inflammatory biomarkers; monounsaturated fat; saturated fat; nuts; plant sterols; vegetable protein; viscous fiber; soy

Outcome Measures

Primary Outcomes (1)

• Feasibility measured by recruitment and retention rates

  Pilot study: Recruitment and retention rates will establish the feasibility of proceeding to the large RCT ie the 9 year intervention study. Long term study (9 years intervention): Non-fatal MI, non-fatal stroke and CV mortality as defined by MACE.

  1 year in a 9 year study

Secondary Outcomes (9)

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

  At months -3, -2, -1 and then at months 0, 3, 6 and 12

• C-reactive protein

  At months -3, -2, -1 and then at months 0, 3, 6 and 12

• Hemoglobin A1c

  At months -3, -2, -1 and then at months 0, 3, 6 and 12

• Glucose

  At months -3, -2, -1 and then at months 0, 3, 6 and 12

• Blood Pressure

  At months -3, -2, -1 and then at months 0, 3, 6 and 12

Study Arms (2)

Enhanced Portfolio plus structured exercise

EXPERIMENTAL

Diet: The dietary portfolio advice: 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 and will emphasize current recommendations for fruit and vegetable intakes (5-10 servings/d).

Behavioral: Enhanced portfolio plus structured exercise

High fiber diet plus routine exercise

ACTIVE COMPARATOR

A diet of whole grain foods (brown rice, whole wheat breads, muffins and breakfast cereals); reduced meat consumption; lower fat dairy foods and a control margarine

Behavioral: High fiber diet plus routine exercise

Interventions

Enhanced portfolio plus structured exercise BEHAVIORAL

Foods on the dietary portfolio plan will contribute 9g/1000 kcal viscous fibre as β-glucan (oats, barley, oat bran breads and soups) and psyllium (cereal), 1g plant sterol/1000 kcal diet (in sterol margarine), 22.5g soy protein/1000 kcal (soy burgers, dogs, links, other soy meat analogues, soy milks, yogurts and cheese), and additional sources of plant protein from pulses (eg. Lentils, chickpeas, beans, etc) and 22.5g almonds or equivalent of other nuts/1000 kcal and increased 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). Exercise: The physical activity/exercise program is based on the program used at the Quebec Heart and Lung Institute.

Also known as: Dietary Portfolio of cholesterol-lowering foods, Laval exercise program

Enhanced Portfolio plus structured exercise

High fiber diet plus routine exercise BEHAVIORAL

Dietary advice will be given to encourage intake of whole grain foods (brown rice, whole wheat breads, muffins and breakfast cereals); to reduce meat consumption, choose low fat dairy products and a control margarine. Exercise: A pamphlet (Canada's Physical Activity Guide, Health Canada) encouraging increased physical activity will be provided.

High fiber diet plus routine exercise

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible participants will be:
• men, over 50
• postmenopausal women, over 60 or
• postmenopausal women under 60 with a family history of hypercholesterolemia and 1 CVD risk factor.
• Participants will have the following characteristics:
• BMI 25-40 kg/m2 with body weight that has remained constant (within ±3%) over the last 3 months preceding the onset of the study
• Plus at least 1 of the following 3 criteria:
• have type 2 diabetes with one of the following:
• raised LDL-C(in accordance with the 2012 Canadian Cardiovascular Society Guidelines)
• raised BP (\> 130/80mmHg), or
• active smoking;
• be non-diabetic subjects post MI or post percutaneous coronary intervention (angioplasty) on statin therapy; and
• have a modified Framingham risk score \>20% (CCS 2012) and are unable (intolerant) or unwilling to take statin drugs.

You may not qualify if:

• Individuals with the following conditions will be excluded:
• cardiovascular disease that precludes exercise e.g.
• recent stroke or
• myocardial infarction, or
• cardiac condition that compromises normal function
• mitral valve disease,
• heart failure--grades 2-4 (New York Heart Association classification),
• severe angina or
• other conditions preventing exercise,
• secondary causes of hypercholesterolemia
• hypothyroidism, (unless treated and on a stable dose of L-thyroxine)
• renal or liver disease
• uncontrolled blood pressure
• major disability
• disorder requiring continuous medical attention and treatment:

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 (13)

• 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.

  PMID: 21862744 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, 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

• 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

• 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, 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

• 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

• 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. doi: 10.1016/s0026-0495(03)00260-9.

  PMID: 14624410 BACKGROUND

• 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. doi: 10.1001/jama.290.4.502.

  PMID: 12876093 BACKGROUND

• Hooper L, Martin N, Jimoh OF, Kirk C, Foster E, Abdelhamid AS. Reduction in saturated fat intake for cardiovascular disease. Cochrane Database Syst Rev. 2020 Aug 21;8(8):CD011737. doi: 10.1002/14651858.CD011737.pub3.

  PMID: 32827219 DERIVED

• Hooper L, Martin N, Jimoh OF, Kirk C, Foster E, Abdelhamid AS. Reduction in saturated fat intake for cardiovascular disease. Cochrane Database Syst Rev. 2020 May 19;5(5):CD011737. doi: 10.1002/14651858.CD011737.pub2.

  PMID: 32428300 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

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 Frohilich, 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: September 23, 2013
• First Posted: October 1, 2013
• Primary Completion: October 7, 2014
• Study Completion: October 7, 2014
• Last Updated: April 26, 2017

Record last verified: 2017-04

Locations

CA (4)