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Recruiting NCT05681468

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

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

Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 175
Sponsor: University of Alberta

Location: University of Alberta Edmonton 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.

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05681468). StuddyBuddy aggregates publicly available trial information.