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Recruiting NCT05681468

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

Trial Parameters

Condition PreDiabetes
Sponsor University of Alberta
Study Type INTERVENTIONAL
Phase N/A
Enrollment 175
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2023-09-18
Completion 2026-05-31
Interventions
Keto-SATKeto-CANLFD

Brief 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.

Eligibility Criteria

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.

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