Preoperative Ketogenic Diet for Reduction of Hepatic Steatosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnton Skaro
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ketogenic Diet
Treatment groups
124 Participants
are divided into 2 treatment groupsSponsors and collaborators
Anton Skaro
Lead sponsor
Western University, Canada
Sponsor institution
Source ClinicalTrials.gov