NCT05681468Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

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.

Status (registry): Active, not recruiting
Study type: Interventional
Enrollment: 164 (actual)
First submitted: 8 Dec 2022
Start date: 18 Sept 2023
Primary completion date: 31 Jan 2027
Lead sponsor: University of Alberta
Diseases: Obesity, Type 2 diabetes
NCT number: NCT05681468

What you commit to

Study type: Interventional
Participants enrolled: 164
From 18 Sept 2023 to the primary completion date, 31 Jan 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

For safety purposes, other individuals would be excluded if are under unstable health conditions.

Other

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

Who the study is looking for

Having overweight or obesity and HbA1C ≥ 5.7% at screening

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

Site	City	Country	Site status
University of Alberta Coordinator of this site? Confirm its status	Edmonton	Canada	Unknown status

Related publications

Protocol for a randomized controlled trial comparing saturated and unsaturated fat sources of a ketogenic diet (KETO-IM) investigating cardiovascular, inflammatory and immune function outcomes in adults living with overweight and prediabetes or type 2 diabetes in Edmonton, Canada.Trials · 2026 · PMID 41673680

This page is information, not medical advice. Discuss any trial with your doctor.