Status:
COMPLETED
Canola-Mediterranean Diet Study in T2DM
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
University of Toronto
Laval University
Conditions:
Type 2 Diabetes
Obesity
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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, glycem...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2017
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT02245399
Start Date
October 1 2014
End Date
March 13 2017
Last Update
September 18 2018
Active Locations (3)
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1
Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
Winnipeg, Manitoba, Canada, R3T 6C5
2
Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, Canada, M5C 2T2
3
Institute of Nutraceuticals and Functional Foods, Laval University
Québec, Quebec, Canada, G1V 4G2