Recruiting

Ketogenic DietPreoperative Ketogenic Diet for Reduction of Hepatic Steatosis

Sponsor:

Anton Skaro

Code:

NCT05884723

Conditions

Liver Steatoses

Liver Metastasis Colon Cancer

NAFLD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ketogenic Diet

Study Details

Brief summary:

Non-alcoholic fatty liver disease is becoming increasingly common in Canada and throughout the world. Fatty liver can increase the risks of perioperative complications for those who need liver surgery. A ketogenic diet is low in carbohydrates and can be very effective in reducing liver fat content. The purpose of this randomized control trial is to compare the effect of a short duration (4 week) preoperative ketogenic diet on operative and disease outcomes in patients undergoing liver surgery. One arm will be randomized to the ketogenic diet and the other will receive standard of care pre-operative dietary consultation.

Conditions

Liver Steatoses

Liver Metastasis Colon Cancer

NAFLD

Study ID

NCT05884723

Start date

May 1, 2024

Status verified date

May, 2026

Completion date

Dec, 2032

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients 18 years of age or older undergoing any type of liver resection (e.g. wedge, formal hepatectomy), either open or laparoscopic, for colorectal liver metastases (CRLM)
Patients with evidence of hepatic steatosis on pre-operative imaging (CT or MR) or biopsy.
Ability to use an app based nutritional program to track macronutrient uptake throughout the dietary intervention.

Exclusion Criteria:

Patients undergoing liver resection for any other indication
Patients on sodium glucose co-transporter 2 (SGLT-2) inhibitors (these are contraindicated with a ketogenic diet).
Patients without evidence of hepatic steatosis.
Patients with evidence of liver fibrosis or cirrhosis on preoperative bloodwork or imaging.
Patients with alcohol-related hepatic steatosis.
Patients with a known bleeding disorder.

Study Design

Enrollment

124 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ketogenic Diet Arm

Participants in this group will be counselled by a registered dietician and then undergo a 4-week preoperative well formulated ketogenic diet. They will record all nutritional uptake during the diet using an app called Cronometer and provide weekly summary reports to the study team.

no intervention: Control Arm

Participants in this group will be counselled by a registered dietician and then undergo a 4-week standard of care diet, as recommended by Canada's Food Guide. They will record all nutritional uptake during the diet using an app called Cronometer and provide weekly summary reports to the study team.

Interventions

Ketogenic Diet

4-week preoperative well-formulated very low carbohydrate isocaloric diet consisting of 50g net daily carbohydrates and 1.5g/kg protein with the remaining energy needs consisting of primarily mono- and polyunsaturated fats

Primary outcome measure

Perioperative blood transfusion [ Time Frame: postoperative days 0-7 ]

Central Contacts and Locations

Central contacts

Anton Skaro, MD PhD

519-685-8500 Anton.Skaro@lhsc.on.ca

Crystal Engelage, PhD

519-685-8500 Crystal.Engelage@lhsc.on.ca

Locations

London Health Sciences Centre/Western University

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Crystal Engelage, PhD

519-685-8500 Crystal.Engelage@lhsc.on.ca

Principal Investigator:

Anton Skaro, MD/PhD

More Information

Sponsor

Anton Skaro

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

ketogenic diet
NAFLD
colorectal liver metastases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Anton Skaro on 2026-05-19.