An interventional study of A canola oil enriched mediterranean diet and A high wheat fiber diet in Type 2 Diabetes, Obesity and Overweight, sponsored by Unity Health Toronto. Completed at 3 sites in Canada. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2018-09-18.
Sponsored by Unity Health Toronto · Not applicable, Interventional, and Treatment
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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Exclusion Criteria:
Individuals with the following characteristics/conditions will be excluded
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
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
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.
Also known as: A mediterranean weight-reducing diet emphasizing canola oil, Eco-Atkins diet, Low carbohydrate dietary portfolio
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
Also known as: DASH-type diet
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
Time frame: Measured at weeks -2, 0, and then at weeks 8, 10 and 12
Change in body weight
Time frame: baseline (week 0) and end (week 12)
blood glucose
Time frame: At weeks 0, 2, 4, 8, 10 and 12
Serum lipids: total cholesterol, LDL-chol, HDL-chol and Triglycerides
Time frame: At weeks 0, 4, 8, 10 and 12
Blood pressure
Time frame: 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
Time frame: 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.
Time frame: At weeks 0, 2, 4, 8, 10 and 12
C-reactive protein
Time frame: 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.
Time frame: 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
Time frame: Weeks 0 and 12
urinary analyses
24 hr urine samples will be analyzed for creatinine, urea, C-peptide, minerals, electrolytes and other dietary biomarkers
Time frame: week 0 and week 12
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.
Time frame: at weeks 0, 2, 4, 8, 10 and 12
Taste (palatability) of the study diets, breads and other supplements given
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.
Time frame: At weeks 2, 4, 8, 10 and 12
The Medical Outcomes Study 36-Item Short Form Questionnaire (SF-36)
Survey on quality of life
Time frame: 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.
Time frame: Week 0 or any other time point
complete blood count (CBC)
Health check at start and end of study
Time frame: Week 0 and week 12
Renal function test
Health check at start and end of study
Time frame: week 0 and week 12
Liver function test
Health check at start and end of study
Time frame: week 0 and week 12
Prostatic specific antigen (PSA)
Male participants will undergo this test.
Time frame: 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.
Time frame: week 10 and week 12
Testosterone level
Male participants will undergo this test
Time frame: week 0 and week 12
Estradiol level
Female participants will undergo this test
Time frame: week 0 and week 12
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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