Recruiting

Ketogenic Diet

Sponsor:

University of Alberta

Code:

NCT05681468

Conditions

PreDiabetes

Diabetes Mellitus, Type 2

Overweight and Obesity

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Keto-SAT

Keto-CAN

LFD

Study Details

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.

Conditions

PreDiabetes

Diabetes Mellitus, Type 2

Overweight and Obesity

Study ID

NCT05681468

Start date

Sep 18, 2023

Status verified date

Jul, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

175 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: KETO-Can

KETO diet supplemented with Canola oil (high in MUFA and omega-3 FA).

experimental: KETO-Sat

KETO diet supplemented with butter and coconut oil (high in SFA).

active comparator: Low fat diet (LFD)

Low fat diet supplemented with whole grain foods (pasta or brown rice) and oatmeal.

Interventions

Keto-SAT

Nutrition counselling focused on Keto diet (saturated fat).

10% TE as carbohydrate (mainly from vegetables and whole grain products), protein between 20-30% TE and fat between 60-70%.

Keto-CAN

Nutrition counselling focused on Keto diet (unsaturated fat).

10% TE as carbohydrate (mainly from vegetables and whole grain products), protein between 20-30% TE and fat between 60-70%.

LFD

Nutrition counselling focused on low-fat diet.

30% total energy (TE) as fat, 50% TE as carbohydrates (primarily whole grains) and 17-20% TE protein (mainly lean sources).

Primary outcome measure

  • Effect of diets on plasma triglycerides levels by comparing groups at 3 months of intervention (i.e. control low fat diet and the 2 keto groups) and changes over time within each group (i.e. baseline vs. 3 months). [ Time Frame: 3 months ]
  • Effect of diets on plasma triglycerides levels by comparing groups at 6 months of intervention (i.e. control low fat diet and the 2 keto groups) and changes over time within each group (i.e. baseline vs. 6 months). [ Time Frame: 6 months ]
  • Effect of diets on LDL-cholesterol levels by comparing groups at 3 months of intervention (i.e. control low fat diet and the 2 keto groups) and changes over time within each group (i.e. baseline vs. 3 months). [ Time Frame: 3 months ]
  • Effect of diets on LDL-cholesterol levels by comparing groups at 6 months of intervention (i.e. control low fat diet and the 2 keto groups) and changes over time within each group (i.e. baseline vs. 6 months). [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Paulina Blanco Cervantes, MSc

7804929506blancoce@ualberta.ca

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2E1

Contacts

Paulina Blanco Cervantes, MSc

780-492-9506blancoce@ualberta.ca

Catherine Chan, PhD

780-492-9939cbchan@ualberta.ca

Principal Investigator:

Catherine Chan, PhD

More Information

Sponsor

University of Alberta

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-07-16.