CirrhosisNCT05376488
Effect of Brief Dietary Intervention on Ammonia Levels
A study testing One meal in people with Cirrhosis and Hepatic Encephalopathy, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.
Trial summary
Study the impact of differing meal contents on venous ammonia levels over time in patients with cirrhosis. Patients will be given specific meals and venous ammonia analyzed over time after those meals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Hepatic Encephalopathy
- What is being tested?
- One meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 20 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Cirrhosis
- Able and willing to voluntarily complete the informed consent process
- Available for and agree to all study procedures
- Consistent non-vegetarian Western dietary patterns for at least a month prior to the study assessed by dietary interview
Who cannot join
- MELD score > 23
- Unclear diagnosis of cirrhosis
- History of liver transplant
- Body mass index < 18.5 or ≥ 40 kg/m2
- Prior transjugular intrahepatic portosystemic shunt placement
- Treatment with systemic (e.g., oral or intravenous) antibiotic (apart from rifaximin) within 4 weeks prior to enrollment
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- For those with HE: stable dose of medications (lactulose or rifaximin) without a recent (<1 month episode of HE)
- Current use of valproate, corticosteroids, or cytotoxic drugs.
- Apart from chronic liver disease, any acute or chronic medical, surgical, psychiatric, or social condition including history of cerebrovascular disease (stroke, transient ischemic attack) or dementia, that may increase the subject risk associated with study participation, compromise adherence to study procedures and requirements, confound interpretation of the results, and, in the judgment of the investigator, make the subject inappropriate for enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
About this study
Official title: Characterization of Venous Ammonia Levels in Fasted and Fed State in Patients With Cirrhosis After Vegetarian, Vegan and Non-Vegetarian Meals
Study the impact of differing meal contents on venous ammonia levels over time in patients with cirrhosis. Patients will be given specific meals and venous ammonia analyzed over time after those meals.
The subjects will also provide stool for microbiome and serum, urine and plasma for metabolomics during this one-time study.
Total duration=4 hours
Read the detailed description
Patient will be instructed to collect stool for baseline assessments. After a fast (>4h from last meal) a venous blood sample will be drawn for analysis of baseline laboratory tests and spot venous ammonia and blood and urine for metabolomics and blood microbiome. Spot ammonia and blood for metabolomics and microbiome will be collected from repeat samples at 1h and 2 hrs after a standardized meals from the three groups of protein meals. Urine will also be collected for metabolomics during the observation period. On the day of the study, patients will be asked to complete a standard food frequency questionnaire encompassing meals over 3 days prior to the study.
Subjects will be randomly assigned into 3 groups (meal types A, B and C) with the standardized meal that contains 20gm of protein. All subjects are expected to consume it in its entirety. Subjects are not allowed to eat anything else until the end of the study.
Subjects will be observed in the unit for a total of 3 hours after the standardized meal to ensure no symptoms related to potential elevated ammonia emerge. Any adverse events will be treated according to standard clinical routine.
- Conditions
- Cirrhosis, Hepatic Encephalopathy
- Being tested
- One meal
- Medical subject headings
- Fibrosis, Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One mealOther
One meal given to assess impact on ammonia levels serially
| Study group | Role | What they receive |
|---|---|---|
| Meal type A | Active comparator | Meal type A: equicaloric meal as meal type B and C with differing constituents Receives: Other: One meal |
| Meal type B | Active comparator | Meal type B: equicaloric meal as meal type A and C with differing constituents Receives: Other: One meal |
| Meal type C | Experimental | Meal type C: equicaloric meal as meal type B and A with differing constituents Receives: Other: One meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous ammonia level
Change in these levels hourly from baseline
Measured: 3 hours
Secondary outcomes (3)
Venous ammonia level
Change in these levels from baseline to hour 1
Measured: 1 hour
Venous ammonia level
Change in these levels from baseline to hour 2
Measured: 2 hours
Venous ammonia level
Change in these levels from baseline to hour 3
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start1 May 2022
- Primary completion20 Dec 2022
- Study completion20 Apr 2023
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized single blind
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jasmohan Bajaj, Principal investigator, Hunter Holmes McGuire VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376488
- Sponsor's protocol ID
- BAJAJ030
- Status last verified
- Feb 2025
- First submitted
- 11 May 2022
- Last updated
- 13 Feb 2025
- 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 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Venous Ammonia Levels in Fasted and Fed State in Patients With Cirrhosis After Vegetarian, Vegan and Non-Vegetarian Meals
- ClinicalTrials.gov ID
- NCT05376488
- Acronym / sponsor ID
- BAJAJ030
- Conditions
- Cirrhosis, Hepatic Encephalopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical CenterUS federal agency
- Study start
- 1 May 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 17 May 2022 (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.
Study the impact of differing meal contents on venous ammonia levels over time in patients with cirrhosis. Patients will be given specific meals and venous ammonia analyzed over time after those meals.
The subjects will also provide stool for microbiome and serum, urine and plasma for metabolomics during this one-time study.
Total duration=4 hours
Detailed description
Patient will be instructed to collect stool for baseline assessments. After a fast (>4h from last meal) a venous blood sample will be drawn for analysis of baseline laboratory tests and spot venous ammonia and blood and urine for metabolomics and blood microbiome. Spot ammonia and blood for metabolomics and microbiome will be collected from repeat samples at 1h and 2 hrs after a standardized meals from the three groups of protein meals. Urine will also be collected for metabolomics during the observation period. On the day of the study, patients will be asked to complete a standard food frequency questionnaire encompassing meals over 3 days prior to the study.
Subjects will be randomly assigned into 3 groups (meal types A, B and C) with the standardized meal that contains 20gm of protein. All subjects are expected to consume it in its entirety. Subjects are not allowed to eat anything else until the end of the study.
Subjects will be observed in the unit for a total of 3 hours after the standardized meal to ensure no symptoms related to potential elevated ammonia emerge. Any adverse events will be treated according to standard clinical routine.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized single blind
| Arm | Type | Receives |
|---|---|---|
| Meal type A | Active comparator | Other: One mealMeal type A: equicaloric meal as meal type B and C with differing constituents |
| Meal type B | Active comparator | Other: One mealMeal type B: equicaloric meal as meal type A and C with differing constituents |
| Meal type C | Experimental | Other: One mealMeal type C: equicaloric meal as meal type B and A with differing constituents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cirrhosis
- Able and willing to voluntarily complete the informed consent process
- Available for and agree to all study procedures
- Consistent non-vegetarian Western dietary patterns for at least a month prior to the study assessed by dietary interview
Key exclusion criteria (9 listed)
- MELD score > 23
- Unclear diagnosis of cirrhosis
- History of liver transplant
- Body mass index < 18.5 or ≥ 40 kg/m2
- Prior transjugular intrahepatic portosystemic shunt placement
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 |
|---|---|---|
| One mealOne meal given to assess impact on ammonia levels serially | Other | Meal type A, Meal type B, Meal type C |
Primary outcome
Venous ammonia level
Time frame: 3 hours
Change in these levels hourly from baseline
3 secondary outcomes
Venous ammonia level
Time frame: 1 hour
Venous ammonia level
Time frame: 2 hours
Venous ammonia level
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- 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. This study is not recruiting at the moment.
Jasmohan Bajaj principal investigator
Hunter Holmes McGuire VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One meal in people with Cirrhosis and Hepatic Encephalopathy, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 13 Feb 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous ammonia level (time frame: 3 hours). 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 13 Feb 2025.