NCT05884723 Preoperative Ketogenic Diet for Reduction of Hepatic Steatosis
| NCT ID | NCT05884723 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Anton Skaro |
| Condition | Liver Steatoses |
| Study Type | INTERVENTIONAL |
| Enrollment | 124 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 124 participants in total. It began in 2024-05-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Anton Skaro, MD PhD
PRINCIPAL INVESTIGATOR
London Health Sciences Centre/Lawson Health Research Institute
Frequently Asked Questions
Who can join the NCT05884723 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Steatoses. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05884723 currently recruiting?
Yes, NCT05884723 is actively recruiting participants. Contact the research team at Anton.Skaro@lhsc.on.ca for enrollment information.
Where is the NCT05884723 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT05884723 clinical trial?
NCT05884723 is sponsored by Anton Skaro. The principal investigator is Anton Skaro, MD PhD at London Health Sciences Centre/Lawson Health Research Institute. The trial plans to enroll 124 participants.