Breath and Blood Ammonia Response to an Oral Protein Challenge

Not Applicable

Completed

• Conditions: Cirrhosis
• Interventions: Dietary Supplement: EAS Myoplex Protein Drink + 10gm lactulose

• Registration Number: NCT02650245
• Lead Sponsor: St. Luke's Hospital and Health Network, Pennsylvania

Brief Summary

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.

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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-15
• Study First Submitted QC: 2016-01-06
• Study First Posted: 2016-01-08
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• <18 and <75 yrs of age

Exclusion Criteria

• Diabetic, smoker, substance abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Moderate protein and 10gm lactulose	EAS Myoplex Protein Drink + 10gm lactulose	40% of daily recommended intake of protein based on weight

Primary Outcome Measures

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

Trial Locations

Locations (1)

St. Luke's University Hospital and Health Network; 🇺🇸 Bethlehem, Pennsylvania, United States