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Sponsors and Collaborators: |
University of Toronto Canadian Institutes of Health Research (CIHR) |
Information provided by: | University of Toronto |
ClinicalTrials.gov Identifier: | NCT00707460 |
The purpose of this study is to evaluate whether or not a traditional First Nations diet (high protein) and/or a dietary intervention based upon current Canadian dietary recommendations (high carbohydrate/high fiber) effects risk factors for type 2 diabetes mellitus and/or cardiovascular disease in a remote fly in First Nations community (Sandy Lake First Nation).
This pilot has been developed in conjunction with Sandy Lake First Nation to answer the research question: Will a traditional diet or a diet based upon current Canadian dietary recommendations result in decreasing risk for type 2 diabetes in Sandy Lake?
Condition | Intervention | Phase |
Type 2 Diabetes Mellitus Cardiovascular Disease Obesity |
Behavioral: Dietary Intervention (Macronutrient composition) |
Phase I |
MedlinePlus related topics: | Diabetes Obesity |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Objective 3: Pilot Dietary Trial; The Sandy Lake Health & Diabetes Project (SLHDP): Understanding and Addressing Metabolic Syndrome, Diabetes and Associated Complications in Aboriginal Canadians |
Estimated Enrollment: | 60 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
Please, see design section for details.
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Behavioral: Dietary Intervention (Macronutrient composition)
The Traditional Diet and Healthy Store-Bought arms differ from the control group and one another by their macronutrient composition. Please, see design section for more detail on this item. All groups are exposed to nutrition education on serving size and portion size. |
2: Experimental
Traditional Diet Please, see design section for details. |
Behavioral: Dietary Intervention (Macronutrient composition)
The Traditional Diet and Healthy Store-Bought arms differ from the control group and one another by their macronutrient composition. Please, see design section for more detail on this item. All groups are exposed to nutrition education on serving size and portion size. |
3: Experimental
Healthy Store-bought Diet Please, see design section for details. |
Behavioral: Dietary Intervention (Macronutrient composition)
The Traditional Diet and Healthy Store-Bought arms differ from the control group and one another by their macronutrient composition. Please, see design section for more detail on this item. All groups are exposed to nutrition education on serving size and portion size. |
Show Detailed Description |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anthony Hanley, PhD | 416-978-3616 | anthony.hanley@utoronto.ca |
Contact: Shannan Grant, BSc, RD, MSc | 416-978-0548 | shannan.grant@utoronto.ca |
Canada, Ontario | |||||
Sandy Lake Health & Diabetes Project Research Office | Recruiting | ||||
Sandy Lake, Ontario, Canada, P0V 1V0 | |||||
Contact: Shannan Grant, BSc, RD, MSc 416-978-0548 shannan.grant@utoronto.ca | |||||
Contact: Mary Mamakeesick, RPN 807-774-5213 |
University of Toronto |
Canadian Institutes of Health Research (CIHR) |
Study Director: | Thomas MS Wolever, DM, PhD | University of Toronto |
Anthony Hanley, PhD, PI 
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Website run by local community staff; no direct ties to UofT 
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Thomas Wolever, study affiliate 
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Responsible Party: | University of Toronto ( Anthony Hanley, PhD ) |
Study ID Numbers: | 22419, MOP44076 |
First Received: | June 26, 2008 |
Last Updated: | June 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00707460 |
Health Authority: | Canada: Ethics Review Committee |
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