Preoperative Ketogenic Diet for Reduction of Hepatic Steatosis

NCT05884723 | Not Yet Recruiting

• 1 other identifier: 122435
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

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

Keywords

ketogenic diet; NAFLD; colorectal liver metastases

Outcome Measures

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)

  postoperative days 0-7

Secondary Outcomes (15)

• Amount of perioperative blood transfusion

  postoperative days 0-7

• Intraoperative blood loss

  Operative period

• Steatosis

  Time of primary surgery

• Change in steatosis

  ~6 weeks

• Operative time

  During primary surgery

Study Arms (2)

Ketogenic Diet Arm

EXPERIMENTAL

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.

Dietary Supplement: Ketogenic Diet

Control Arm

NO INTERVENTION

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 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

Ketogenic Diet Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western University, Canada: lead

MeSH Terms

Conditions

Fatty Liver; Non-alcoholic Fatty Liver Disease

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Anton Skaro, MD PhD

  London Health Sciences Centre/Lawson Health Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anton Skaro, MD PhD

CONTACT

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

Crystal Engelage, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The surgeons, surgical team, and data abstractors will be blinded to participant randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: preoperative ketogenic diet group vs control standard of care preoperative diet

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: June 1, 2023
• Study Start: May 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2030
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share