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

Overweight and Obesity | Diabetes Mellitus, Type 2 | PreDiabetes

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.

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    18 to 70

Participation 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.

Study Location

University of Alberta
University of Alberta
Edmonton, Alberta
Canada

Contact Study Team

Primary Contact

Paulina Blanco Cervantes, MSc

[email protected]
780-492-9506
Backup Contact

Catherine Chan, PhD

[email protected]
780-492-9939
Study Sponsored By
University of Alberta
Participants Required
More Information
Study ID: NCT05681468