Liver SteatosesNCT05884723
Preoperative Ketogenic Diet for Reduction of Hepatic Steatosis
A study testing Ketogenic Diet in people with Liver Steatoses and Liver Metastasis Colon Cancer, run by Anton Skaro at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Steatoses, Liver Metastasis Colon Cancer, NAFLD
- What is being tested?
- Ketogenic Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2024to Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre/Western University
London, Ontario, N6A 5A5
Crystal Engelage, PhD, 519-685-8500 ext. 37517, Crystal.Engelage@lhsc.on.ca
Anton Skaro, MD/PhD
About this study
Official title: Implementation of a Preoperative Ketogenic Diet for Reduction of Hepatic Steatosis Prior to Hepatectomy: a Randomized Control 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.
Read the 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.
- Conditions
- Liver Steatoses, Liver Metastasis Colon Cancer, NAFLD
- Being tested
- Ketogenic Diet
- Keywords
- ketogenic diet, NAFLD, colorectal liver metastases
- Medical subject headings
- Fatty Liver, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic DietDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative blood transfusion
receipt (binary) of packed red blood cell (pRBC) units intraoperatively and during the immediate postoperative time period (POD 0 - 7)
Measured: postoperative days 0-7
Secondary outcomes (15)
Amount of perioperative blood transfusion
Number of pRBC units transfused
Measured: postoperative days 0-7
Intraoperative blood loss
Intraoperative blood loss: measured by net sponge weight and fluid suctioned minus irrigation fluid
Measured: Operative period
Steatosis
Level of steatosis in liver resection specimen
Measured: Time of primary surgery
Change in steatosis
Change in steatosis in liver pre-diet vs day of surgery
Measured: ~6 weeks
Operative time
time from surgery start to surgery stop
Measured: During primary surgery
Postoperative complications
Postoperative complications (measured via the Clavien-Dindo Index) will be assessed within 30 days of the operation.
Measured: Postoperative days 0-30
Postoperative length of hospital stay
Postoperative length of hospital stay will be assessed.
Measured: Postoperative days 0-30
Postoperative hospital readmission
Hospital readmission will be assessed within 30 days of the operation
Measured: Postoperative days 0-30
Postoperative rates of reoperation
Reoperation rates will be assessed within 30 days of the initial surgery.
Measured: Postoperative days 0-30
Postoperative liver failure
Liver failure rates will be assessed within 30 days of the initial surgery.
Measured: Postoperative days 0-30
Postoperative mortality
Mortality rates will be assessed within 30 days of the initial surgery.
Measured: Postoperative days 0-30
Adherence to ketogenic diet
whether participants adhered to the diet assigned to them
Measured: 4 weeks
Disease recurrence
Time to disease recurrence will be assessed up to 5 years postoperatively.
Measured: 0 - 5 years postoperatively
Measurement of circulating cell-free tumor DNA
Circulating cell-free tumour DNA levels will be measured up to 5 years postoperatively.
Measured: 0 - 5 years postoperatively
Cancer-related mortality
Cancer-related mortality rates will be assessed up to 5 years postoperatively.
Measured: 0 - 5 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 May 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver SteatosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- preoperative ketogenic diet group vs control standard of care preoperative diet
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anton Skaro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anton Skaro, Western University, Canada
- Investigators
- Anton Skaro, MD PhD, Principal investigator, London Health Sciences Centre/Lawson Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884723
- Sponsor's protocol ID
- 122435
- Status last verified
- May 2026
- First submitted
- 15 May 2023
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Preoperative Ketogenic Diet for Reduction of Hepatic Steatosis Prior to Hepatectomy: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05884723
- Acronym / sponsor ID
- 122435
- Conditions
- Liver Steatoses, Liver Metastasis Colon Cancer, NAFLD
- Keywords
- ketogenic diet, NAFLD, colorectal liver metastases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Anton SkaroUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- preoperative ketogenic diet group vs control standard of care preoperative diet
| Arm | Type | Receives |
|---|---|---|
| Ketogenic Diet Arm | Experimental | Dietary Supplement: Ketogenic DietParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic Diet4-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 | Dietary supplement | Ketogenic Diet Arm |
Primary outcome
Perioperative blood transfusion
Time frame: postoperative days 0-7
receipt (binary) of packed red blood cell (pRBC) units intraoperatively and during the immediate postoperative time period (POD 0 - 7)
15 secondary outcomes
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
Disease recurrence
Time frame: 0 - 5 years postoperatively
Measurement of circulating cell-free tumor DNA
Time frame: 0 - 5 years postoperatively
Cancer-related mortality
Time frame: 0 - 5 years postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anton Skaro, MD PhD principal investigator
London Health Sciences Centre/Lawson Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic Diet in people with Liver Steatoses and Liver Metastasis Colon Cancer, run by Anton Skaro at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anton Skaro, MD PhD (519-685-8500 ext. 32904, Anton.Skaro@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative blood transfusion (time frame: postoperative days 0-7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.