Breath and Blood Ammonia Response to an Oral Protein Challenge

The investigators specific aim is to evaluate the changes in breath ammonia in comparison to blood ammonia and other physiologic markers after a moderate oral protein challenge in healthy subjects and subjects with liver cirrhosis.

Study Overview

• Status: Completed
• Conditions: Cirrhosis
• Intervention / Treatment: Dietary supplement: EAS Myoplex Protein Drink + 10gm lactulose

Detailed Description

Ammonia is an important molecule relevant to numerous diseases, especially to the millions of patients with cirrhosis worldwide. Venous blood ammonia via limb phlebotomy, can at best roughly estimate whole body ammonia, but says little or nothing about intestinal production, and cannot "source" ammonia to any particular organ or body compartment. Unfortunately, there are no presently available better tests. Therefore, despite these acknowledged limitations, venous ammonia the "bronze standard" benchmark by which new metrics are assessed.

The present protocol attempts to address both concerns and build upon the investigators prior high protein experience. By using a standard moderate protein challenge, the investigators can evaluate the breath ammonia responsiveness in healthy subjects and those with cirrhosis. This protocol leverages the power of breath research to evaluate responses to oral challenges. This remains a key asset of breath research.

Since the protocol proposes a moderate protein challenge, the investigators can evaluate disease states with minimal or no risk. As with past high protein studies, lactulose (10gm) will still be added to provoke a hydrogen response.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's University Hospital and Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• <18 and <75 yrs of age

Exclusion Criteria:

• Diabetic, smoker, substance abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moderate protein and 10gm lactulose; 40% of daily recommended intake of protein based on weight	Dietary supplement: EAS Myoplex Protein Drink + 10gm lactulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of Ammonia (parts per billion) in response to an oral protein challenge using the Bedfont breath monitor	Evaluating change in breath ammonia at hour 5 compared to baseline	5 hours

Collaborators and Investigators

• Sponsor: St. Luke's Hospital and Health Network, Pennsylvania
• Investigators: Principal Investigator: Steve Solga, M.D., St. Luke's University Hospital and Health Network

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: October 15, 2015
• First Submitted That Met QC Criteria: January 6, 2016
• First Posted (Estimate): January 8, 2016

Study Record Updates

• Last Update Posted (Estimate): October 13, 2016
• Last Update Submitted That Met QC Criteria: October 12, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: blood; cirrhosis; protein; encephalopathy; ammonia; gastroenterology; breath
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Gastrointestinal Agents; Lactulose
• Other Study ID Numbers: 2015-59