Canola-Mediterranean Diet Study in T2DM

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Canola Enriched Mediterranean Type Weight Loss Diet in Type 2 Diabetes

Conditions
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Type 2 Diabetes, Obesity, Overweight, Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: A canola oil enriched mediterranean diet
* Behavioral: A high wheat fiber diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women with type 2 diabetes diagnosed for more than 6 months 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: Individuals with the following characteristics/conditions will be excluded 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A canola oil enriched mediterranean diet<br>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. | Behavioral: A canola oil enriched mediterranean diet<br>* 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.<br>* Other names: Low carbohydrate dietary portfolio;|
| Active Comparator: A high wheat fiber diet<br>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. | Behavioral: A high wheat fiber diet<br>* 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<br>* Other names: DASH-type diet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight loss, Diabetes, Cardiovascular disease (CVD) risk, Weight loss diet, mediterranean type diet, Canola oil, Low-carbohydrate diet, Glycemic index