Comparing different fat sources in ketogenic diets for diabetes management
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
NA · University of Alberta · NCT05681468
This study is testing whether a ketogenic diet with canola oil is better for managing diabetes than a traditional high-fat ketogenic diet or a low-fat diet in adults at risk for or diagnosed with type 2 diabetes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 175 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Alberta (other) |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT05681468 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effects of a ketogenic diet supplemented with canola oil against a traditional ketogenic diet high in saturated fats and a low-fat diet in adults at risk of or diagnosed with type 2 diabetes. Participants will be randomly assigned to one of the three dietary interventions and will receive nutrition counseling over a six-month period. The study will assess cardiovascular risk factors, systemic inflammation, and adherence to the diets through blood samples and anthropometric measurements taken at baseline, 3 months, and 6 months.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with overweight or obesity and an HbA1C level of 5.7% or higher.
Not a fit: Patients with specific nutritional habits that prevent adherence to the dietary recommendations or those with unstable health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into healthier dietary fat sources that improve metabolic and inflammatory outcomes for patients with type 2 diabetes.
How similar studies have performed: Previous studies have shown promising results with dietary interventions for diabetes management, but this specific comparison of fat sources in ketogenic diets is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Edmonton, Alberta
- University of Alberta — Edmonton, Alberta, Canada (RECRUITING)
Study contacts
- Principal investigator: Catherine Chan, PhD — University of Alberta
- Study coordinator: Paulina Blanco Cervantes, MSc
- Email: blancoce@ualberta.ca
- Phone: 7804929506
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: PreDiabetes, Diabetes Mellitus, Type 2, Overweight and Obesity