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| ID | Type | Description | Link |
|---|---|---|---|
| CFC/Fund 200134/496744 | Other Identifier | Canola Council of Canada |
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| Name | Class |
|---|---|
| University of Toronto | OTHER |
| Laval University | OTHER |
| University of Manitoba | OTHER |
| Canola Council of Canada |
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The purpose of the study is to assess whether a Mediterranean-type weight-loss diet, enriched with canola oil, high in plant protein, and low in carbohydrates will produce blood sugar control, reduce coronary heart disease (CHD) risk factors and maximize weight loss, better than conventional higher carbohydrate diets in overweight diabetic patients.
The investigators plan to assess the effects of increasing both canola oil and plant protein foods while reducing carbohydrate intake in the context of a Mediterranean type diet on weight loss, glycemic control and cardiovascular risk factors in type 2 diabetes.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A canola oil enriched mediterranean diet | Experimental | 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. |
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| A high wheat fiber diet | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A canola oil enriched mediterranean diet | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| change in HbA1c | The baseline HbA1c will be the average HbA1c of weeks -2 and week 0. The end HbA1c will be the average HbA1c of weeks 8, 10 and 12. Change will be the difference between the end and baseline values | Measured at weeks -2, 0, and then at weeks 8, 10 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | baseline (week 0) and end (week 12) | |
| blood glucose | At weeks 0, 2, 4, 8, 10 and 12 | |
| Serum lipids: total cholesterol, LDL-chol, HDL-chol and Triglycerides |
| Measure | Description | Time Frame |
|---|---|---|
| Satiety | Using a 9-point bipolar semantic scale where -4 is extremely hungry, 0 is neutral and +4 is uncomfortably full, participants will rate their overall feeling of satiety for the previous week. | at weeks 0, 2, 4, 8, 10 and 12 |
| Taste (palatability) of the study diets, breads and other supplements given |
Inclusion Criteria:
Exclusion Criteria:
Individuals with the following characteristics/conditions will be excluded
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| Name | Affiliation | Role |
|---|---|---|
| David J Jenkins, MD | St. Michael's Hospital / University of Toronto | Principal Investigator |
| Cyril Kendall, PhD | University of Toronto | Study Director |
| Vladimir Vuksan, PhD | Unity Health Toronto | Study Director |
| Peter Jones, PhD | University of Manitoba | Study Director |
| Benoit Lamarche, PhD | Laval University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba | Winnipeg | Manitoba | R3T 6C5 | Canada | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18268511 | Background | 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. | |
| 14963049 | Background | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D050177 | Overweight |
| D002318 | Cardiovascular Diseases |
| D015431 | Weight Loss |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| OTHER |
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|
| A high wheat fiber diet | Behavioral | 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 |
|
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| At weeks 0, 4, 8, 10 and 12 |
| Blood pressure | At weeks 0, 4, 8, 10 and 12 |
| 24-hour Ambulatory blood pressure profile | Measurement will be done using a non-invasive SpaceLabs 90217 Ambulatory BP monitor | At weeks -1 and 12 |
| diet history | 7-day food records brought in at weeks 0, 2, 4, 8, 10 and 12 will be analyzed for macro and micro nutrient intakes. | At weeks 0, 2, 4, 8, 10 and 12 |
| C-reactive protein | At weeks 0 and 12 |
| Cholesterol absorption | This is an optional sub-study that will be carried out prior to the first and last weeks of the 12 week study. On day 1 (a Monday) of the week -1 and last weeks of the study after an overnight 12hr fast, blood will be drawn and participants will be asked to ingest 75mg of the stable carbon isotope [3, 4-13C] cholesterol dissolved in 5g of margarine and spread on half of an English muffin. Subsequent blood draws will be taken after an overnight 12hr fast, at 48 h (a Wednesday) and 72 h (a Thursday) after ingestion of the labeled cholesterol. | At weeks -1 and 12 |
| change in LDL particle size | LDL particle size at weeks 0 and 12 will be determined by assessing their electrophoretic characteristics obtained by non-denaturing polyacrylamide gradient (2-16%) gel electrophoresis of serum | Weeks 0 and 12 |
| urinary analyses | 24 hr urine samples will be analyzed for creatinine, urea, C-peptide, minerals, electrolytes and other dietary biomarkers | week 0 and week 12 |
Using a scale of 1 (strongly dislike) to 10 (like very much), participants will rate the taste (palatability) of the study diet and supplements including study breads, vegan 'meats' and egg products. |
| At weeks 2, 4, 8, 10 and 12 |
| The Medical Outcomes Study 36-Item Short Form Questionnaire (SF-36) | Survey on quality of life | At weeks 0 and 12 |
| Genetic whole genome testing | One time sample collection of buffy coat (from white cells) for future study on gene, diet and chronic disease relationship. | Week 0 or any other time point |
| complete blood count (CBC) | Health check at start and end of study | Week 0 and week 12 |
| Renal function test | Health check at start and end of study | week 0 and week 12 |
| Liver function test | Health check at start and end of study | week 0 and week 12 |
| Prostatic specific antigen (PSA) | Male participants will undergo this test. | week 0 and week 12 |
| sustainability of diet | using a scale of 1 (study diet will be very difficult to sustain) to 10 (study diet will be very easy to sustain) participants will assess how sustainable their assigned diet will be on a long-term basis. | week 10 and week 12 |
| Testosterone level | Male participants will undergo this test | week 0 and week 12 |
| Estradiol level | Female participants will undergo this test | week 0 and week 12 |
| Risk Factor Modification Centre, St. Michael's Hospital |
| Toronto |
| Ontario |
| M5C 2T2 |
| Canada |
| Institute of Nutraceuticals and Functional Foods, Laval University | Québec | Quebec | G1V 4G2 | Canada |
| 18635428 | 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. |
| 19506174 | Background | 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. |
| 22100977 | Background | 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. |
| 11282918 | Background | 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. |
| 19246357 | Background | 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. |
| 4337382 | Background | 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. |
| 24500611 | Background | 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. |
| 11445904 | Background | 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. |
| 36156115 | Derived | 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. |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |