Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources

Recruiting now · Not applicable

Conditions studied: PreDiabetes, Diabetes Mellitus, Type 2, Overweight and Obesity

In brief

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 facts

Study ID

NCT05681468

Run by

University of Alberta

People needed

175

Starts

2023-09-18

Expected to finish

2027-01-31

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Having overweight or obesity and HbA1C ≥ 5.7% at screening

You may not qualify if…

• 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

• University of Alberta — Edmonton, Alberta, Canada (enrolling)

Full record on ClinicalTrials.gov

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