NCT05681468 Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
| NCT ID | NCT05681468 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alberta |
| Condition | PreDiabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 175 participants |
| Start Date | 2023-09-18 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 175 participants in total. It began in 2023-09-18 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Catherine Chan, PhD
PRINCIPAL INVESTIGATOR
University of Alberta
Frequently Asked Questions
Who can join the NCT05681468 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying PreDiabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05681468 currently recruiting?
Yes, NCT05681468 is actively recruiting participants. Contact the research team at blancoce@ualberta.ca for enrollment information.
Where is the NCT05681468 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT05681468 clinical trial?
NCT05681468 is sponsored by University of Alberta. The principal investigator is Catherine Chan, PhD at University of Alberta. The trial plans to enroll 175 participants.
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