Preoperative Ketogenic Diet for Reduction of Hepatic Steatosis

Western University, Canada

Status: Not yet enrolling

Conditions: Liver Steatoses; NAFLD; Liver Metastasis Colon Cancer

Treatments: Dietary Supplement: Ketogenic Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05884723

122435

Details and patient eligibility

About

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.

Full description

The rise in obesity has contributed to increasing rates of non-alcoholic fatty liver disease (NAFLD) in Canada and globally. In the setting of liver surgery, fatty liver has been associated with higher rates of blood loss during surgery as well as higher rates of postoperative complications. A pre-operative ketogenic diet (KD) has been proposed as a strategy to decrease the risks of fatty liver in patients undergoing liver surgery and has shown promising results in reducing liver fat content, even with short-duration diets. The current literature contains a large variety of pre-operative diets aimed at reducing liver fat content and most studies are observational. Presently, there is no randomized control trial looking at the effects of a well-formulated and standardized KD prior to liver surgery and its effect on operative and disease outcomes. This study will randomize patients with NAFLD needing surgery to remove liver tumors to either the control group or intervention group. Patients in the control group will receive dietary consultation for a standard of care diet as recommended by Canada's Food Guide. Patients in the intervention group will consult with a dietician before starting a 4-week preoperative well-formulated very low carbohydrate KD. All participants will track daily nutritional intake and provide weekly summary reports via an app called Cronometer. The investigators will analyze differences in intraoperative blood loss and OR time, postoperative complications, disease recurrence and mortality rates between the two groups.

Enrollment: 124 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 2 patient groups

Ketogenic Diet Arm

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Ketogenic Diet

Control Arm

No Intervention group

Description:

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.