KETO-IM Study
Metabolic and inflammatory outcomes of the ketogenic diet comparing saturated and unsaturated fat sources
About the KETO-IM Study
Low-carbohydrate diets, including ketogenic diet (KETO) are gaining interest as a treatment for type 2 diabetes because they are believed to help manage blood sugar and weight. However, KETO is often high in saturated fats. Compared with a traditional KETO, we want to test the feasibility of substituting healthier fats such as canola oil to improve cardiovascular risk factors.
Canola oil is low in saturated fat. Therefore, utilizing canola oil in a KETO diet may improve its health benefits in people with high risk of / living with type 2 diabetes. The goal of our research is to compare consuming a KETO based on either canola oil or saturated fat to a lower fat diet typically recommended for diabetes for 6 months on blood sugar, factors related to the immune system, and other outcomes.
KETO-IM is an exciting study happening at the University of Alberta. Joining this study is entirely voluntary.
Eligibility
Men or women aged 18-70 years old
Living with overweight or obesity
Living with high sugar levels* or Type 2 Diabetes
*If you don't know about your sugar levels, the Keto-IM study team could test them.
Find out if you are eligible
What will happen during the study?
The study will last 6 months and will involve 8-11 visits to the study site over this time.
Participants will be randomized to one of three diets:
Traditional KETO supplemented with butter and coconut oil (Keto-Sat)
KETO diet supplemented with Canola oil (Keto-Can)
Low-fat diet supplemented with whole grains and other low-fat foods.
You will receive nutrition counselling and key ingredients of your assigned diet (in addition to foods you buy yourself). For 6 months you will follow this specific diet (keto-can, keto-sat, low-fat diet) with the guidance of a nutrition expert from the study team.
During the study you will receive a pedometer you will need to wear to assess your physical activity levels.
Each month, you will pick up the key ingredients and bring back any leftovers (in addition to foods you buy yourself).
At 3 months you will visit our research unit to have study visit in which we will collect some samples and information.
At 6 months will be your final visit in which we will collect final samples and information from you
What do we collect?
Questionnaires concerning your eating habits.
Blood measurements.
Body measurements (height, weight, circumferences, and body composition).
Urine sample (to assess ketones if in the Keto group).
Blood pressure.
Stool samples (optional).
Location
University of Alberta (North Campus)
We are located at the Human Nutrition Research Unit on the 2nd floor of Li Ka Shing Centre for Health Innovation.
2-004 8602 112 Street, University of Alberta. Edmonton, AB,T6G 2E1
Compensation
As a token of appreciation for your time you will receive a $50 gift card at 3 months and another $50 gift card at 6 months (upon completion of the study).
We will cover costs for public transportation or parking of all your visits.
Ethics Approval and Funding
This study has been reviewed for its adherence to ethical guidelines by a Research Ethics Board at the University of Alberta (Pro00123687).
ClinicalTrials.gov Identifier: NCT05681468
Funding: Alberta Agriculture and Forestry and Alberta Canola
Stay connected with us
If you are interested in participating or have additional questions, please contact us.
Phone: (780) 492-9506
email: keto.im@ualberta.ca
