Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Alberta
About this trial
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
Qualifiers
Having overweight or obesity and HbA1C ≥ 5.7% at screening
Disqualifiers
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
Trial design
Treatments tested in this trial
- Keto-SAT
- Keto-CAN
- LFD
Treatment groups
175 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov