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Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
Sponsor: University of Alberta
Summary
The goal of this clinical trial is to compare a healthy KETO diet supplemented with canola oil (KETO-Can) compared to a traditional KETO diet high in saturated fat (KETO-Sat) and low-fat diet (LFD) in adults at high risk of or diagnosed with type 2 diabetes. The main question\[s\] it aims to answer are: * Effects on CVD risk factors (plasma cholesterol, TG, ApoB100, glucose, insulin and HbA1C). * Effects on systemic inflammation and immune function. * Adherence to interventions. Participants will be randomized into 1 of the dietary treatments during which they will follow a Keto or a low-fat diet. Comparisons among groups at 3 and 6 months of intervention will be conducted.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
175
Start Date
2023-09-18
Completion Date
2026-05-31
Last Updated
2026-01-08
Healthy Volunteers
No
Interventions
Keto-SAT
Nutrition counselling focused on Keto diet (saturated fat). 10% TE as carbohydrate (mainly from vegetables and whole grain products), protein between 20-30% TE and fat between 60-70%.
Keto-CAN
Nutrition counselling focused on Keto diet (unsaturated fat). 10% TE as carbohydrate (mainly from vegetables and whole grain products), protein between 20-30% TE and fat between 60-70%.
LFD
Nutrition counselling focused on low-fat diet. 30% total energy (TE) as fat, 50% TE as carbohydrates (primarily whole grains) and 17-20% TE protein (mainly lean sources).
Locations (1)
University of Alberta
Edmonton, Alberta, Canada