CirrhosisSUPPRESS-HENCT07634237
Personalized Nutritional Intervention in Patients Undergoing TIPS Insertion for Refractory Ascites to Prevent Overt Hepatic Encephalopathy
A study testing High Energy and High Protein Diet 1 and High Energy and High Protein Diet 2 in people with Cirrhosis and Refractory Ascites, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
This study will evaluate whether a nutritional intervention is better than another to reduce the incidence of overt hepatic encephalopathy in patients undergoing TIPS insertion for refractory ascites. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis, Refractory Ascites, TIPS Insertion
- What is being tested?
- High Energy and High Protein Diet 1 and High Energy and High Protein Diet 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jun 2026to 15 Dec 2029
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of cirrhosis
- TIPS planned for refractory ascites
- Being at least moderately malnourished
Who cannot join
- TIPS insertion for other reason than refractory ascites
- Budd Chiari Syndrome
- Complete or cavernomatous portal vein thrombosis
- Pre-TIPS recurrent or persistent overt hepatic encephalopathy
- Use of lactulose or rifaximin in the last 4 weeks
- Liver failure (MELD > 18 or Child Pugh score > 12)
Show all 11Show fewer
- Heart failure (NYHA ≥ III or LVEF < 50%)
- Kidney failure (serum creatinine > 250µmol/L)
- Pregnancy or breastfeeding
- Previous Liver transplantation
- Unable to provide informed consent
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
McGill University Health Centre
Montreal, Quebec
Nassim Oumansour, BSc, 514-934-1934, nassim.oumansour@rimuhc.ca
About this study
Official title: Personalized Nutritional Intervention to Prevent Overt Hepatic Encephalopathy in Patients With Cirrhosis and Refractory Ascites Who Undergo TIPS Insertion: A Multicenter Randomized Controlled Trial (SUPPRESS-HE Trial)
This study will evaluate whether a nutritional intervention is better than another to reduce the incidence of overt hepatic encephalopathy in patients undergoing TIPS insertion for refractory ascites.
- Conditions
- Cirrhosis, Refractory Ascites, TIPS Insertion
- Being tested
- High Energy and High Protein Diet 1, High Energy and High Protein Diet 2
- Keywords
- Personalized Nutritional Intervention, Overt Hepatic Encephalopathy, Cirrhosis, Refractory Ascites, TIPS Insertion
- Medical subject headings
- Fibrosis, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Energy and High Protein Diet 1Dietary supplement
As participants are blinded, description of the intervention is meant to maintain the blinding. Participants will meet the study dietitian who will perform a nutritional assessment. The study dietitian will then prescribe a high-energy and high-protein diet with or without the use of oral nutritional supplements that will fit your taste preferences and dietary needs. The nutritional intervention will focus on having 3 meals per day and 3 snacks per day, including at bedtime.
High Energy and High Protein Diet 2Dietary supplement
As participants are blinded, description of the intervention is meant to maintain the blinding. Participants will meet the study dietitian who will perform a nutritional assessment. The study dietitian will then prescribe a high-energy and high-protein diet with or without the use of oral nutritional supplements that will fit your taste preferences and dietary needs. The nutritional intervention will focus on having 3 meals per day and 3 snacks per day, including at bedtime.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Intervention 1 | Experimental | As participants are blinded, description of the arm is meant to maintain the blinding. Participants will meet the study dietitian who will perform a nutritional assessment. The study dietitian will then prescribe a high-energy and high-protein diet with or without the use of oral nutritional supplements that will fit your taste preferences and dietary needs. The nutritional intervention will focus on having 3 meals per day and 3 snacks per day, including at bedtime. Receives: Dietary Supplement: High Energy and High Protein Diet 1 |
| Nutrition Intervention 2 | Active comparator | As participants are blinded, description of the arm is meant to maintain the blinding. Participants will meet the study dietitian who will perform a nutritional assessment. The study dietitian will then prescribe a high-energy and high-protein diet with or without the use of oral nutritional supplements that will fit your taste preferences and dietary needs. The nutritional intervention will focus on having 3 meals per day and 3 snacks per day, including at bedtime. Receives: Dietary Supplement: High Energy and High Protein Diet 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of overt hepatic encephalopathy
Measured: 6 months
Secondary outcomes (4)
Changes in nutritional status using the PG-SGA scale
Measured: 6 months
Changes in brain function using the Stroop Test (EncephalApp)
Measured: 6 months
Changes in frailty using the Liver Frailty Index
Measured: 6 months
Changes in patient-reported outcomes using Chronic Liver Disease Questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jun 2029 (estimated)
- Study completion15 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Amine Benmassaoud, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Amine Benmassaoud, MD, Principal investigator, Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634237
- Sponsor's protocol ID
- MP-37-2025-10963
- Acronym
- SUPPRESS-HE
- Status last verified
- Jun 2026
- First submitted
- 14 Apr 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Nutritional Intervention to Prevent Overt Hepatic Encephalopathy in Patients With Cirrhosis and Refractory Ascites Who Undergo TIPS Insertion: A Multicenter Randomized Controlled Trial (SUPPRESS-HE Trial)
- ClinicalTrials.gov ID
- NCT07634237
- Acronym / sponsor ID
- SUPPRESS-HE / MP-37-2025-10963
- Conditions
- Cirrhosis, Refractory Ascites, TIPS Insertion
- Keywords
- Personalized Nutritional Intervention, Overt Hepatic Encephalopathy, Cirrhosis, Refractory Ascites, TIPS Insertion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jun 2029 (estimated)
- Study completion
- 15 Dec 2029 (estimated)
- First posted
- 8 Jun 2026 (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.
This study will evaluate whether a nutritional intervention is better than another to reduce the incidence of overt hepatic encephalopathy in patients undergoing TIPS insertion for refractory ascites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition Intervention 1 | Experimental | Dietary Supplement: High Energy and High Protein Diet 1As participants are blinded, description of the arm is meant to maintain the blinding. Participants will meet the study dietitian who will perform a nutritional assessment. The study dietitian will then prescribe a high-energy and high-protein diet with or without the use of oral nutritional supplements that will fit your taste preferences and dietary needs. The nutritional intervention will focus on having 3 meals per day and 3 snacks per day, including at bedtime. |
| Nutrition Intervention 2 | Active comparator | Dietary Supplement: High Energy and High Protein Diet 2As participants are blinded, description of the arm is meant to maintain the blinding. Participants will meet the study dietitian who will perform a nutritional assessment. The study dietitian will then prescribe a high-energy and high-protein diet with or without the use of oral nutritional supplements that will fit your taste preferences and dietary needs. The nutritional intervention will focus on having 3 meals per day and 3 snacks per day, including at bedtime. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of cirrhosis
- TIPS planned for refractory ascites
- Being at least moderately malnourished
Key exclusion criteria (11 listed)
- TIPS insertion for other reason than refractory ascites
- Budd Chiari Syndrome
- Complete or cavernomatous portal vein thrombosis
- Pre-TIPS recurrent or persistent overt hepatic encephalopathy
- Use of lactulose or rifaximin in the last 4 weeks
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 |
|---|---|---|
| High Energy and High Protein Diet 1As participants are blinded, description of the intervention is meant to maintain the blinding. Participants will meet the study dietitian who will perform a nutritional assessment. The study dietitian will then prescribe a high-energy and high-protein diet with or without the use of oral nutritional supplements that will fit your taste preferences and dietary needs. The nutritional intervention will focus on having 3 meals per day and 3 snacks per day, including at bedtime. | Dietary supplement | Nutrition Intervention 1 |
| High Energy and High Protein Diet 2As participants are blinded, description of the intervention is meant to maintain the blinding. Participants will meet the study dietitian who will perform a nutritional assessment. The study dietitian will then prescribe a high-energy and high-protein diet with or without the use of oral nutritional supplements that will fit your taste preferences and dietary needs. The nutritional intervention will focus on having 3 meals per day and 3 snacks per day, including at bedtime. | Dietary supplement | Nutrition Intervention 2 |
Primary outcome
Incidence of overt hepatic encephalopathy
Time frame: 6 months
4 secondary outcomes
Changes in nutritional status using the PG-SGA scale
Time frame: 6 months
Changes in brain function using the Stroop Test (EncephalApp)
Time frame: 6 months
Changes in frailty using the Liver Frailty Index
Time frame: 6 months
Changes in patient-reported outcomes using Chronic Liver Disease Questionnaire
Time frame: 6 months
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 8 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Cirrhosis
Not yet recruitingObservational study
Inflammatory and Neuroimmune Guided Investigation of Underlying Fatigue in Patients With Cirrhosis
Cirrhosis Alcoholic, Fatigue Symptom
RecruitingPhase 2
Study of Seladelpar and Cilofexor in Participants With Primary Biliary Cholangitis
Primary Biliary Cholangitis
Active, not recruitingObservational study
AI-SC Multi-center Study
Liver Cirrhosis
RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Not yet recruitingObservational study
Within-Session Repeatability of EUS-Guided Portal Pressure Gradient Measurement
Portal Hypertension, Chronic Liver Disease
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.
Amine Benmassaoud, MD principal investigator
Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Energy and High Protein Diet 1 and High Energy and High Protein Diet 2 in people with Cirrhosis and Refractory Ascites, run by McGill University Health Centre/Research Institute of the McGill University Health Centre 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 11 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: opening soon, as of the sponsor's last update on 8 Jun 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 Nassim Oumansour, BSc (514-934-1934 ext. 34868, nassim.oumansour@rimuhc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of overt hepatic encephalopathy (time frame: 6 months). 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 8 Jun 2026.