Effect of Brief Dietary Intervention on Ammonia Levels

NCT ID: NCT05376488

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-04-20

Brief 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.

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.

Conditions

Cirrhosis; Hepatic Encephalopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Meal type A

Meal type A: equicaloric meal as meal type B and C with differing constituents

Group Type: ACTIVE_COMPARATOR

One meal

Intervention Type: OTHER

One meal given to assess impact on ammonia levels serially

Meal type B

Meal type B: equicaloric meal as meal type A and C with differing constituents

Group Type: ACTIVE_COMPARATOR

One meal

Intervention Type: OTHER

One meal given to assess impact on ammonia levels serially

Meal type C

Meal type C: equicaloric meal as meal type B and A with differing constituents

Group Type: EXPERIMENTAL

One meal

Intervention Type: OTHER

One meal given to assess impact on ammonia levels serially

Interventions

One meal

One meal given to assess impact on ammonia levels serially

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Cirrhosis

2. Able and willing to voluntarily complete the informed consent process

3. Available for and agree to all study procedures

4. Consistent non-vegetarian Western dietary patterns for at least a month prior to the study assessed by dietary interview

Exclusion Criteria

1. MELD score > 23

2. Unclear diagnosis of cirrhosis

3. History of liver transplant

4. Body mass index < 18.5 or ≥ 40 kg/m2

5. Prior transjugular intrahepatic portosystemic shunt placement

6. Treatment with systemic (e.g., oral or intravenous) antibiotic (apart from rifaximin) within 4 weeks prior to enrollment

7. For those with HE: stable dose of medications (lactulose or rifaximin) without a recent (<1 month episode of HE)

8. Current use of valproate, corticosteroids, or cytotoxic drugs.

9. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hunter Holmes Mcguire Veteran Affairs Medical Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jasmohan Bajaj

Role: PRINCIPAL_INVESTIGATOR

Hunter Holmes McGuire VAMC

Locations

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

BAJAJ030

Identifier Type: -

Identifier Source: org_study_id