Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
Recruiting · NCT05681468 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Alberta
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Having overweight or obesity and HbA1C ≥ 5.7% at screening
Exclusion criteria
- Individuals with specific nutritional habits preventing them from adhering to nutritional recommendations
- Pregnant women
- People on dialysis or recommended to follow a low-protein diet (base on glomerular filtration rate)
- Familial hypercholesterolemia or hypertriglyceridemia
- Transitioning trans-gender
- For safety purposes, other individuals would be excluded if are under unstable health conditions.
Where it is running
1 location listed.
- University of Alberta - Edmonton, Alberta, Canada