Cardiovascular DiseasesEDP8NCT01954472
Enhanced Multicenter Dietary Portfolio Study
A study testing Enhanced portfolio plus structured exercise and High fiber diet plus routine exercise in people with Cardiovascular Diseases and Type 2 Diabetes, run by Unity Health Toronto at 4 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cardiovascular Diseases, Type 2 Diabetes, Hypercholesterolemia
- What is being tested?
- Enhanced portfolio plus structured exercise and High fiber diet plus routine exercise
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Inclusion Criteria:
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.
- Exclusion Criteria:
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:
- chronic heart failure,
- liver disease,
- renal failure or
- cancer (except non-melanoma skin cancer--basal cell, squamous cell),
- chronic infections (bacterial or viral)
- chronic inflammatory diseases (e.g. lupus, ulcerative colitis)
- other autoimmune diseases
- major surgery <6 months prior to randomization
- alcohol consumption >2 drinks/d.
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 Effect of an Enhanced Dietary Portfolio Plus Exercise on Cardiovascular Risk in High Risk Individuals.
"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.
Read the detailed description
There is a major need for a large RCT to demonstrate the effect of lifestyle modification (diet and exercise) on cardiovascular disease (CVD) outcomes. The pilot study will demonstrate the feasibility as a prerequisite for continuing on to the large RCT. Large RCT: This trial will test the effect of a high impact dietary approach combining foods with functional effects, including LDL-cholesterol (LDL-C) and blood pressure (BP) reduction, together with an exercise program which has been associated with reduction in carotid atheroma assessed by MRI. The combined approach will have a more significant effect on CVD risk factors than previous trials and will be compared with a high cereal fibre diet and exercise advice, consistent with good clinical practice, in a randomized parallel trial of 9 years duration. ~6,000 high risk participants will be recruited comprising individuals with 1) type 2 diabetes, 2) post myocardial infarction (MI), and 3) Statin intolerant individuals. The primary outcome will be CVD event (MI, and stroke, fatal and non-fatal) (1). We believe we will achieve a 20% reduction in CVD events with ~10% related to diet reflected in reduction in traditional risk factors (LDL-C, BP) and 10% to exercise and increased cardiovascular fitness at year 9.
Pilot Study: We therefore propose to undertake a 1 year pilot study with 200 participants to demonstrate feasibility: 1) Successful recruitment (200 participants/year) and 2) retention (>90%)
Background: We have demonstrated the specific CVD reducing potential of the proposed components of our dietary intervention in a series of CIHR funded studies. The core dietary components (dietary portfolio of FDA approved cholesterol-lowering foods) in our recent CIHR-funded trial reduced LDL-C by 13-14% (JAMA 2011) with reductions also in diastolic blood pressure over 6 months. The CVD risk score was reduced by ~10% on the treatment. This approach will be combined with increased levels of monounsaturated fat (MUFA) which in a further CIHR-funded portfolio study raised HDL-C and reduced the total:HDL-C ratio (CMAJ 2010) resulting in an ~11% CVD risk score reduction on the high MUFA compared to the low MUFA portfolio. Low glycemic index foods will be selected which in our CIHR-funded trial in type 2 diabetes increased HDL-C and reduced HbA1c, the total:HDL-C ratio (JAMA 2008) and, with the added emphasis on legumes (dried peas, beans, lentils), significantly reduced BP leading to a CVD risk score reduction of ~5% (Arch Intern Med 2012). We consider this dietary package to have major potential in CVD risk reduction with a possible reduction in relative risk of 24% in the absence of negative or positive interactions.
The physical activity/exercise intervention is the end-product of a 25 year cumulative experience of investigators of the Quebec Heart and Lung Institute regarding physical activity/exercise prescriptions to various types of individuals/patients. Our program has also been recently tested in high risk patients with documented coronary artery disease managed by coronary artery bypass graft procedure (with/without type 2 diabetes). Unpublished preliminary results from this latter intervention in high risk patients indicate that our program not only induces substantial improvements in the CVD risk factor profile beyond clinical guidelines-aligned with optimal pharmacotherapy but that such an intervention appears to induce a significant reduction in carotid artery atherosclerosis assessed by magnetic resonance imaging. The latest meta-analysis estimated that only 150 min/week of moderate exercise reduced CHD risk by 14%. Our Laval program with a 420 min/wk of moderate exercise plus additional structured exercise would therefore also reduce CVD risk by at least 14% (or as much as 39% if the relationship between exercise time and CVD risk reduction were linear). The program aims to reduce sedentary behavior. It is safe and affordable in clinical practice. At a cost of about $900 per patient in the first year where the major training takes place, it is considerably less expensive than the DPP, DPS and Look AHEAD trials.
The research questions are therefore:
- What is the feasibility in terms of recruitment and retention of implementing a high impact diet and physical activity/exercise program for CVD prevention in high risk or statin-intolerant individuals?
- Based on the observed retention in the pilot study, the required recruitment for the large trial can be refined, if necessary.
- Being tested
- Enhanced portfolio plus structured exercise, High fiber diet plus routine exercise
- 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
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2, Hypercholesterolemia, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced portfolio plus structured exerciseBehavioural
Also called Dietary Portfolio of cholesterol-lowering foods, Laval exercise program
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.
High fiber diet plus routine exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 Receives: Behavioral: High fiber diet plus routine exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year in a 9 year study
Secondary outcomes (9)
Serum lipids: total cholesterol, LDL-chol, HDL-chol and Triglycerides
Measured: At months -3, -2, -1 and then at months 0, 3, 6 and 12
C-reactive protein
Measured: At months -3, -2, -1 and then at months 0, 3, 6 and 12
Hemoglobin A1c
Measured: At months -3, -2, -1 and then at months 0, 3, 6 and 12
Glucose
Measured: At months -3, -2, -1 and then at months 0, 3, 6 and 12
Blood Pressure
Measured: At months -3, -2, -1 and then at months 0, 3, 6 and 12
treadmill testing
Measured: At months 0 and 12
diet history
Measured: At months -3, -2, -1 and then at months 0, 3, 6 and12
Pedometer records
Measured: At months 0, 2, 4, 6, 8, 10 and 12
Exercise history
Measured: At months 0, 3, 6, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Primary completion7 Oct 2014
- Study completion7 Oct 2014
Why it stopped: This study was combined with another CIHR funded study (NCT02078635). Both studies involve the same dietary portfolio and the same study population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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 Frohilich, MD, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954472
- Sponsor's protocol ID
- REB 13-188
- Other IDs
- FRN 130278
- Acronym
- EDP8
- Status last verified
- Apr 2017
- First submitted
- 23 Sep 2013
- Last updated
- 26 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 21862744Jenkins 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 21041432Jenkins 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 23089999Borel 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.
PubMed 22262155Borel 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.
PubMed 21864868Pelletier-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.
PubMed 22321874Jenkins 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, 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.
PubMed 12489074Jenkins 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.
PubMed 16522904Jenkins 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.
PubMed 14624410Jenkins 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 12876093Hooper 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.
PubMed 32827219Hooper 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.
PubMed 32428300
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Enhanced Dietary Portfolio Plus Exercise on Cardiovascular Risk in High Risk Individuals.
- ClinicalTrials.gov ID
- NCT01954472
- Acronym / sponsor ID
- EDP8 / REB 13-188
- Keywords
- Portfolio diet, dietary modification, hypercholesterolemia, diabetes, Exercise, CVD risk, glycemic index, inflammatory biomarkers
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was combined with another CIHR funded study (NCT02078635). Both studies involve the same dietary portfolio and the same study population.
- 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
- 1 Oct 2013 (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.
"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.
Detailed description
There is a major need for a large RCT to demonstrate the effect of lifestyle modification (diet and exercise) on cardiovascular disease (CVD) outcomes. The pilot study will demonstrate the feasibility as a prerequisite for continuing on to the large RCT. Large RCT: This trial will test the effect of a high impact dietary approach combining foods with functional effects, including LDL-cholesterol (LDL-C) and blood pressure (BP) reduction, together with an exercise program which has been associated with reduction in carotid atheroma assessed by MRI. The combined approach will have a more significant effect on CVD risk factors than previous trials and will be compared with a high cereal fibre diet and exercise advice, consistent with good clinical practice, in a randomized parallel trial of 9 years duration. ~6,000 high risk participants will be recruited comprising individuals with 1) type 2 diabetes, 2) post myocardial infarction (MI), and 3) Statin intolerant individuals. The primary outcome will be CVD event (MI, and stroke, fatal and non-fatal) (1). We believe we will achieve a 20% reduction in CVD events with ~10% related to diet reflected in reduction in traditional risk factors (LDL-C, BP) and 10% to exercise and increased cardiovascular fitness at year 9.
Pilot Study: We therefore propose to undertake a 1 year pilot study with 200 participants to demonstrate feasibility: 1) Successful recruitment (200 participants/year) and 2) retention (>90%)
Background: We have demonstrated the specific CVD reducing potential of the proposed components of our dietary intervention in a series of CIHR funded studies. The core dietary components (dietary portfolio of FDA approved cholesterol-lowering foods) in our recent CIHR-funded trial reduced LDL-C by 13-14% (JAMA 2011) with reductions also in diastolic blood pressure over 6 months. The CVD risk score was reduced by ~10% on the treatment. This approach will be combined with increased levels of monounsaturated fat (MUFA) which in a further CIHR-funded portfolio study raised HDL-C and reduced the total:HDL-C ratio (CMAJ 2010) resulting in an ~11% CVD risk score reduction on the high MUFA compared to the low MUFA portfolio. Low glycemic index foods will be selected which in our CIHR-funded trial in type 2 diabetes increased HDL-C and reduced HbA1c, the total:HDL-C ratio (JAMA 2008) and, with the added emphasis on legumes (dried peas, beans, lentils), significantly reduced BP leading to a CVD risk score reduction of ~5% (Arch Intern Med 2012). We consider this dietary package to have major potential in CVD risk reduction with a possible reduction in relative risk of 24% in the absence of negative or positive interactions.
The physical activity/exercise intervention is the end-product of a 25 year cumulative experience of investigators of the Quebec Heart and Lung Institute regarding physical activity/exercise prescriptions to various types of individuals/patients. Our program has also been recently tested in high risk patients with documented coronary artery disease managed by coronary artery bypass graft procedure (with/without type 2 diabetes). Unpublished preliminary results from this latter intervention in high risk patients indicate that our program not only induces substantial improvements in the CVD risk factor profile beyond clinical guidelines-aligned with optimal pharmacotherapy but that such an intervention appears to induce a significant reduction in carotid artery atherosclerosis assessed by magnetic resonance imaging. The latest meta-analysis estimated that only 150 min/week of moderate exercise reduced CHD risk by 14%. Our Laval program with a 420 min/wk of moderate exercise plus additional structured exercise would therefore also reduce CVD risk by at least 14% (or as much as 39% if the relationship between exercise time and CVD risk reduction were linear). The program aims to reduce sedentary behavior. It is safe and affordable in clinical practice. At a cost of about $900 per patient in the first year where the major training takes place, it is considerably less expensive than the DPP, DPS and Look AHEAD trials.
The research questions are therefore:
- What is the feasibility in terms of recruitment and retention of implementing a high impact diet and physical activity/exercise program for CVD prevention in high risk or statin-intolerant individuals?
- Based on the observed retention in the pilot study, the required recruitment for the large trial can be refined, if necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Portfolio plus structured exercise | Experimental | Behavioral: Enhanced portfolio plus structured exerciseDiet: 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). |
| High fiber diet plus routine exercise | Active comparator | Behavioral: High fiber diet plus routine exerciseA 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Enhanced portfolio plus structured exerciseAlso: Dietary Portfolio of cholesterol-lowering foods, Laval exercise programFoods 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. | Behavioural | Enhanced Portfolio plus structured exercise |
| High fiber diet plus routine exerciseDietary 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. | Behavioural | High fiber diet plus routine exercise |
Primary outcome
Feasibility measured by recruitment and retention rates
Time frame: 1 year in a 9 year study
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.
9 secondary outcomes
Serum lipids: total cholesterol, LDL-chol, HDL-chol and Triglycerides
Time frame: At months -3, -2, -1 and then at months 0, 3, 6 and 12
C-reactive protein
Time frame: At months -3, -2, -1 and then at months 0, 3, 6 and 12
Hemoglobin A1c
Time frame: At months -3, -2, -1 and then at months 0, 3, 6 and 12
Glucose
Time frame: At months -3, -2, -1 and then at months 0, 3, 6 and 12
Blood Pressure
Time frame: At months -3, -2, -1 and then at months 0, 3, 6 and 12
treadmill testing
Time frame: At months 0 and 12
diet history
Time frame: At months -3, -2, -1 and then at months 0, 3, 6 and12
Pedometer records
Time frame: At months 0, 2, 4, 6, 8, 10 and 12
Exercise history
Time frame: At months 0, 3, 6, and 12
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 26 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.
- 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 23089999Jenkins 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.
- Background: PubMed 22262155Borel 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.
- Background: PubMed 21864868Borel 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.
- Background: PubMed 22321874Pelletier-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.
- 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.
- Background: PubMed 12489074Jenkins 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.
- Background: PubMed 16522904Jenkins 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.
- Background: PubMed 14624410Jenkins 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.
- Background: PubMed 12876093Jenkins 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.
- Derived from this study: PubMed 32827219Hooper 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.
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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 Enhanced portfolio plus structured exercise and High fiber diet plus routine exercise in people with Cardiovascular Diseases and Type 2 Diabetes, 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?
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 26 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?
Feasibility measured by recruitment and retention rates (time frame: 1 year in a 9 year study). 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 NCT01954472, which also lists 13 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 26 Apr 2017.