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

NCT05681468 | Recruiting

• 1 other identifier: Pro00123687
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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).

  Assess triglycerides levels collecting blood samples in a fasting state. Triglycerides will be determined using commercially available equipment at a local laboratory (Roche Cobas c503). Measurements will be performed for between group comparison and within groups comparison to understand the effect of diets.

  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).

  Assess triglycerides levels collecting blood samples in a fasting state. Triglycerides will be determined using commercially available equipment at a local laboratory (Roche Cobas c503). Measurements will be performed for between group comparison and within groups comparison to understand the effect of diets.

  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).

  Assess LDL-cholesterol levels collecting blood samples in a fasting state. LDL-Cholesterol levels will be determined using commercially available equipment at a local laboratory (Roche Cobas c503). Measurements will be performed for between group comparison and within groups comparison to understand the effect of diets.

  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).

  Assess LDL-cholesterol levels collecting blood samples in a fasting state. LDL-Cholesterol levels will be determined using commercially available equipment at a local laboratory (Roche Cobas c503). Measurements will be performed for between group comparison and within groups comparison to understand the effect of diets.

  6 months

Secondary Outcomes (12)

• Effect of diets on blood glucose 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).

  3 months

• Effect of diets on blood glucose 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).

  6 months

• Effect of diets on insulin 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).

  3 months

• Effect of diets on insulin 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).

  6 months

• Effect of diets on hemoglobin A1C (HbA1c) 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).

  3 months

Other Outcomes (3)

• Adherence to diet interventions using 24-hour dietary assessment tool

  4 weeks

• Change in fatty acid composition to confirm adherence to the diets at 3 months

  3 months

• Change in fatty acid composition to confirm adherence to the diets at 6 months

  6 months

Study Arms (3)

KETO-Can

EXPERIMENTAL

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

Other: Keto-CAN

KETO-Sat

EXPERIMENTAL

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

Other: Keto-SAT

Low fat diet (LFD)

ACTIVE COMPARATOR

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

Other: LFD

Interventions

Keto-SAT OTHER

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-Sat

Keto-CAN OTHER

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%.

KETO-Can

LFD OTHER

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).

Low fat diet (LFD)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having overweight or obesity and HbA1C ≥ 5.7% at screening

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

RECRUITING

Related Publications (1)

• Harbarenko JL, Gartke T, Blanco Cervantes P, Mojibi Y, Makarowski A, Richard C, Chan CB. 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 Feb 11. doi: 10.1186/s13063-026-09501-0. Online ahead of print.

  PMID: 41673680 DERIVED

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus, Type 2; Overweight; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Catherine Chan, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paulina Blanco Cervantes, MSc

CONTACT

7804929506; blancoce@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial (3-parallel arm study).

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: January 12, 2023
• Study Start: September 18, 2023
• Primary Completion: May 31, 2026
• Study Completion: May 31, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

CA (1)