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