Study Results
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Basic Information
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COMPLETED
NA
164 participants
INTERVENTIONAL
2014-10-31
2017-03-13
Brief Summary
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Detailed Description
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Obesity rates in Western nations have shown a dramatic rise in the last 20 years and diabetes rates have doubled, a trend which is predicted to be repeated over the next 20 years. In Canada the predicted cost to the healthcare system in only 7 years will rise to $17 billion. Weight loss diets (such as Atkins, Eddies, South Beach and Zone) emphasizing carbohydrate restriction have become increasingly popular for the prevention and treatment of diabetes. As a result, lower carbohydrate diets are being selected by health conscious members of the general population including those with diabetes. Because such diets in effect promote a high intake of protein from animal sources, even in the presence of weight loss, serum cholesterol levels rise due to increased cholesterol and saturated fat intake; and a further rise in serum lipids is likely to occur in the long term when weight loss has ceased. On the other hand, lower carbohydrate dietary patterns that are higher in plant rather than animal fat and proteins have been associated with improved blood lipids and reduced risk of heart disease and type 2 diabetes.
The investigators have therefore planned a study in which a weight reducing low carbohydrate, Mediterranean type diet that is high in plant proteins and canola oil will be compared to a weight reducing high cereal fibre diet in a 3 month study. 150 overweight and obese participants with type 2 diabetes will be randomized to one of 2 treatments.
Study visits will be as follows: weeks -2, 0 (for randomization), 2, 4, 8, 10 and 12. Body measurements, blood pressure and blood samples will be taken at each visit except week 2. The week 2 visit will be mainly for reinforcement of dietary advice; also body weight will be measured and blood drawn for fast glucose and HbA1c. Diet records will be reviewed at all visits. 24 hour urine samples will be collected at week 0 and week 12.
On completion of the 12 week study, participants will be given the option of continuing on the same diet or trying the opposite diet for a further 12 weeks. Visits will be every 4 weeks for a total of 3 visit. Body measurements, blood pressure and blood samples will be taken during these visits as in the initial 12 week study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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A canola oil enriched mediterranean diet
Participants will be advised to consume, a low-carbohydrate diet (26-32% of calories), high in vegetable protein (28-32%) and fat (41-45%) with canola as the major component (10%). Carbohydrate sources will feature viscous fiber-containing foods (including psyllium cereal, oats and barley) and low-starch vegetables (emphasizing okra and eggplant) for the relatively limited amount of carbohydrate.
A canola oil enriched mediterranean diet
The diet will be provided at 60% of calories estimated for stable body weight to encourage weight loss. A high protein canola oil-enriched test bread will be provided as a supplement.
A high wheat fiber diet
Participant will be advised to consume a high carbohydrate diet (58% carbohydrate, 16% protein and 25% fat) emphasizing whole wheat/whole grain cereals and increased high fiber alternatives, with fruits and vegetables.
A high wheat fiber diet
The diet will be provided at 60% of calories estimated for stable body weight to encourage weight loss. A whole wheat control bread will be provided as a supplement to participants
Interventions
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A canola oil enriched mediterranean diet
The diet will be provided at 60% of calories estimated for stable body weight to encourage weight loss. A high protein canola oil-enriched test bread will be provided as a supplement.
A high wheat fiber diet
The diet will be provided at 60% of calories estimated for stable body weight to encourage weight loss. A whole wheat control bread will be provided as a supplement to participants
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI \>27 (non-Asians); BMI \>25 (Asians)
* HbA1c between 6.5% and 8.5% at screening, and at the preparation visit before starting diet
* on a stable prescribed dose of oral diabetes medication for at least 2 months
* on a stable dose of lipid medication for at least 2 weeks, if prescribed
* on a stable dose of blood pressure medication for at least 1 week, if prescribed
* have a family physician
* can keep written food records, with the use of a digital scale
Exclusion Criteria
* on insulin
* on steroids
* on warfarin (Coumadin)
* GI disease (gastroparesis, celiac, colitis, Crohn's disease, Inflammatory Bowel Syndrome)
* history of cancer, except non-melanoma skin cancer (basal cell, squamous cell)
* major cardiovascular event (stroke, myocardial infarction) in past 6 months
* major surgery in past 6 months
* major debilitating disorder
* liver disease (AST or ALT\> 3x the upper limit of normal) except non-alcoholic fatty liver (NAFL) disease or non-alcoholic steatohepatitis (NASH).
* hepatitis B or C
* renal failure (creatinine \> 150 mmol/L)
* serum triglycerides \>4.5mmol/L
* acute or chronic infections (bacterial or viral)
* chronic inflammatory diseases (e.g. lupus, ulcerative colitis)
* blood pressure \>145/90, unless approved by their family physician
* alcohol consumption \>2 drinks/d
* food allergies to wheat, canola, or other study food components
* any condition determined by the investigators to make the subject unsuitable for the study
21 Years
ALL
No
Sponsors
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University of Toronto
OTHER
Laval University
OTHER
University of Manitoba
OTHER
Canola Council of Canada
OTHER
Unity Health Toronto
OTHER
Responsible Party
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Principal Investigators
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David J Jenkins, MD
Role: PRINCIPAL_INVESTIGATOR
St. Michael's Hospital / University of Toronto
Cyril Kendall, PhD
Role: STUDY_DIRECTOR
University of Toronto
Vladimir Vuksan, PhD
Role: STUDY_DIRECTOR
Unity Health Toronto
Peter Jones, PhD
Role: STUDY_DIRECTOR
University of Manitoba
Benoit Lamarche, PhD
Role: STUDY_DIRECTOR
Laval University
Locations
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Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
Winnipeg, Manitoba, Canada
Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, Canada
Institute of Nutraceuticals and Functional Foods, Laval University
Québec, Quebec, Canada
Countries
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References
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Alhassan S, Kim S, Bersamin A, King AC, Gardner CD. Dietary adherence and weight loss success among overweight women: results from the A TO Z weight loss study. Int J Obes (Lond). 2008 Jun;32(6):985-91. doi: 10.1038/ijo.2008.8. Epub 2008 Feb 12.
Anderson JW, Randles KM, Kendall CW, Jenkins DJ. Carbohydrate and fiber recommendations for individuals with diabetes: a quantitative assessment and meta-analysis of the evidence. J Am Coll Nutr. 2004 Feb;23(1):5-17. doi: 10.1080/07315724.2004.10719338.
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.
Jenkins DJ, Wong JM, Kendall CW, Esfahani A, Ng VW, Leong TC, Faulkner DA, Vidgen E, Greaves KA, Paul G, Singer W. The effect of a plant-based low-carbohydrate ("Eco-Atkins") diet on body weight and blood lipid concentrations in hyperlipidemic subjects. Arch Intern Med. 2009 Jun 8;169(11):1046-54. doi: 10.1001/archinternmed.2009.115.
Guariguata L, Whiting D, Weil C, Unwin N. The International Diabetes Federation diabetes atlas methodology for estimating global and national prevalence of diabetes in adults. Diabetes Res Clin Pract. 2011 Dec;94(3):322-32. doi: 10.1016/j.diabres.2011.10.040. Epub 2011 Nov 17.
Kris-Etherton P, Eckel RH, Howard BV, St Jeor S, Bazzarre TL; Nutrition Committee Population Science Committee and Clinical Science Committee of the American Heart Association. AHA Science Advisory: Lyon Diet Heart Study. Benefits of a Mediterranean-style, National Cholesterol Education Program/American Heart Association Step I Dietary Pattern on Cardiovascular Disease. Circulation. 2001 Apr 3;103(13):1823-5. doi: 10.1161/01.cir.103.13.1823. No abstract available.
Sacks FM, Bray GA, Carey VJ, Smith SR, Ryan DH, Anton SD, McManus K, Champagne CM, Bishop LM, Laranjo N, Leboff MS, Rood JC, de Jonge L, Greenway FL, Loria CM, Obarzanek E, Williamson DA. Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates. N Engl J Med. 2009 Feb 26;360(9):859-73. doi: 10.1056/NEJMoa0804748.
Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972 Jun;18(6):499-502. No abstract available.
Jenkins DJ, Wong JM, Kendall CW, Esfahani A, Ng VW, Leong TC, Faulkner DA, Vidgen E, Paul G, Mukherjea R, Krul ES, Singer W. Effect of a 6-month vegan low-carbohydrate ('Eco-Atkins') diet on cardiovascular risk factors and body weight in hyperlipidaemic adults: a randomised controlled trial. BMJ Open. 2014 Feb 5;4(2):e003505. doi: 10.1136/bmjopen-2013-003505.
Gremaud G, Piguet C, Baumgartner M, Pouteau E, Decarli B, Berger A, Fay LB. Simultaneous assessment of cholesterol absorption and synthesis in humans using on-line gas chromatography/ combustion and gas chromatography/pyrolysis/isotope-ratio mass spectrometry. Rapid Commun Mass Spectrom. 2001;15(14):1207-13. doi: 10.1002/rcm.365.
Jenkins DJ, Jones PJ, Abdullah MM, Lamarche B, Faulkner D, Patel D, Sahye-Pudaruth S, Paquette M, Bashyam B, Pichika SC, Kavanagh ME, Patel P, Liang F, Brown R, Zhao T, Phan M, Mathiyalagan G, Tandon S, Vuksan V, Jovanovski E, Sievenpiper JL, Kendall CW, Leiter LA, Josse RG. Low-carbohydrate vegan diets in diabetes for weight loss and sustainability: a randomized controlled trial. Am J Clin Nutr. 2022 Nov;116(5):1240-1250. doi: 10.1093/ajcn/nqac203. Epub 2023 Feb 10.
Other Identifiers
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CFC/Fund 200134/496744
Identifier Type: OTHER
Identifier Source: secondary_id
REB# 14-086
Identifier Type: -
Identifier Source: org_study_id
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