Canola-Mediterranean Diet Study in T2DM
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02245399|
Recruitment Status : Completed
First Posted : September 19, 2014
Last Update Posted : September 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Obesity Overweight Cardiovascular Diseases||Behavioral: A canola oil enriched mediterranean diet Behavioral: A high wheat fiber diet||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||164 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Canola Enriched Mediterranean Type Weight Loss Diet in Type 2 Diabetes|
|Actual Study Start Date :||October 2014|
|Actual Primary Completion Date :||December 14, 2016|
|Actual Study Completion Date :||March 13, 2017|
Experimental: 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.
Behavioral: 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.
Active Comparator: 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.
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 whole wheat control bread will be provided as a supplement to participants
Other Name: DASH-type diet
- change in HbA1c [ Time Frame: Measured at weeks -2, 0, and then at weeks 8, 10 and 12 ]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
- 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 [ Time Frame: At weeks -1 and 12 ]Measurement will be done using a non-invasive SpaceLabs 90217 Ambulatory BP monitor
- diet history [ Time Frame: At weeks 0, 2, 4, 8, 10 and 12 ]7-day food records brought in at weeks 0, 2, 4, 8, 10 and 12 will be analyzed for macro and micro nutrient intakes.
- C-reactive protein [ Time Frame: At weeks 0 and 12 ]
- Cholesterol absorption [ Time Frame: At weeks -1 and 12 ]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.
- change in LDL particle size [ Time Frame: Weeks 0 and 12 ]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
- urinary analyses [ Time Frame: week 0 and week 12 ]24 hr urine samples will be analyzed for creatinine, urea, C-peptide, minerals, electrolytes and other dietary biomarkers
- Satiety [ Time Frame: at weeks 0, 2, 4, 8, 10 and 12 ]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.
- Taste (palatability) of the study diets, breads and other supplements given [ Time Frame: At weeks 2, 4, 8, 10 and 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.
- The Medical Outcomes Study 36-Item Short Form Questionnaire (SF-36) [ Time Frame: At weeks 0 and 12 ]Survey on quality of life
- Genetic whole genome testing [ Time Frame: Week 0 or any other time point ]One time sample collection of buffy coat (from white cells) for future study on gene, diet and chronic disease relationship.
- complete blood count (CBC) [ Time Frame: Week 0 and week 12 ]Health check at start and end of study
- Renal function test [ Time Frame: week 0 and week 12 ]Health check at start and end of study
- Liver function test [ Time Frame: week 0 and week 12 ]Health check at start and end of study
- Prostatic specific antigen (PSA) [ Time Frame: week 0 and week 12 ]Male participants will undergo this test.
- sustainability of diet [ Time Frame: week 10 and week 12 ]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.
- Testosterone level [ Time Frame: week 0 and week 12 ]Male participants will undergo this test
- Estradiol level [ Time Frame: week 0 and week 12 ]Female participants will undergo this test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02245399
|Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba|
|Winnipeg, Manitoba, Canada, R3T 6C5|
|Risk Factor Modification Centre, St. Michael's Hospital|
|Toronto, Ontario, Canada, M5C 2T2|
|Institute of Nutraceuticals and Functional Foods, Laval University|
|Quebec City, Quebec, Canada, G1V 4G2|
|Principal Investigator:||David J Jenkins, MD||St. Michael's Hospital / University of Toronto|
|Study Director:||Cyril Kendall, PhD||University of Toronto|
|Study Director:||Vladimir Vuksan, PhD||St. Michael's Hospital, Toronto|
|Study Director:||Peter Jones, PhD||University of Manitoba|
|Study Director:||Benoit Lamarche, PhD||Laval University|