Effect of Brief Dietary Intervention on Ammonia Levels

NCT05376488 | Completed

• 1 other identifier: BAJAJ030
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Cirrhosis; Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• Venous ammonia level

  Change in these levels hourly from baseline

  3 hours

Secondary Outcomes (3)

• Venous ammonia level

  1 hour

• Venous ammonia level

  2 hours

• Venous ammonia level

  3 hours

Study Arms (3)

Meal type A

ACTIVE COMPARATOR

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

Other: One meal

Meal type B

ACTIVE COMPARATOR

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

Other: One meal

Meal type C

EXPERIMENTAL

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

Other: One meal

Interventions

One meal OTHER

One meal given to assess impact on ammonia levels serially

Meal type A; Meal type B; Meal type C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Hunter Holmes Mcguire Veteran Affairs Medical Center: lead

Study Sites (1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Fibrosis; Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jasmohan Bajaj

  Hunter Holmes McGuire VAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients are blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized single blind

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 17, 2022
• Study Start: May 1, 2022
• Primary Completion: December 20, 2022
• Study Completion: April 20, 2023
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)