Preoperative Ketogenic Diet for Reduction of Hepatic Steatosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketogenic Diet.
- Who it may be relevant to
- Registry conditions: Liver Steatoses, Liver Metastasis Colon Cancer, NAFLD. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Implementation of a Preoperative Ketogenic Diet for Reduction of Hepatic Steatosis Prior to Hepatectomy: a Randomized Control Trial
Overview
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.
Detailed 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.
Interventions
- Dietary supplement Ketogenic Diet
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
Primary outcome measures
- Perioperative blood transfusion [Time frame: postoperative days 0-7]
Secondary outcome measures (12)
- Amount of perioperative blood transfusion [Time frame: postoperative days 0-7]
- Intraoperative blood loss [Time frame: Operative period]
- Steatosis [Time frame: Time of primary surgery]
- Change in steatosis [Time frame: ~6 weeks]
- Operative time [Time frame: During primary surgery]
- Postoperative complications [Time frame: Postoperative days 0-30]
- Postoperative length of hospital stay [Time frame: Postoperative days 0-30]
- Postoperative hospital readmission [Time frame: Postoperative days 0-30]
- Postoperative rates of reoperation [Time frame: Postoperative days 0-30]
- Postoperative liver failure [Time frame: Postoperative days 0-30]
- Postoperative mortality [Time frame: Postoperative days 0-30]
- Adherence to ketogenic diet [Time frame: 4 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- London Health Sciences Centre/Western University — London
Identifiers
NCT: NCT05884723 · 122435