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Preoperative Ketogenic Diet for Reduction of Hepatic Steatosis

ConditionsLiver SteatosesLiver Metastasis Colon CancerNAFLD
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Ketogenic Diet

    Dietary supplement

    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

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: Ketogenic Diet ArmExperimental treatment 1 intervention
Group B: Control ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Perioperative blood transfusion

receipt (binary) of packed red blood cell (pRBC) units intraoperatively and during the immediate postoperative time period (POD 0 - 7)

Time frame
postoperative days 0-7

Secondary outcomes

1

Amount of perioperative blood transfusion

Number of pRBC units transfused

Time frame
postoperative days 0-7
2

Intraoperative blood loss

Intraoperative blood loss: measured by net sponge weight and fluid suctioned minus irrigation fluid

Time frame
Operative period
3

Steatosis

Level of steatosis in liver resection specimen

Time frame
Time of primary surgery
4

Change in steatosis

Change in steatosis in liver pre-diet vs day of surgery

Time frame
~6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anton Skaro

Lead sponsor

Western University, Canada

Sponsor institution

Source ClinicalTrials.gov
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