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Breath and Blood Ammonia Response to an Oral Protein Challenge

Breath and Blood Ammonia Response to an Oral Protein Challenge

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02650245
Enrollment
12
Registered
2016-01-08
Start date
2015-10-31
Completion date
2016-04-30
Last updated
2016-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis

Keywords

breath, gastroenterology, ammonia, blood, protein, cirrhosis, encephalopathy

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.

Interventions

DIETARY_SUPPLEMENTEAS Myoplex Protein Drink + 10gm lactulose

Sponsors

St. Luke's Hospital and Health Network, Pennsylvania
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* \<18 and \<75 yrs of age

Exclusion criteria

* Diabetic, smoker, substance abuse

Design outcomes

Primary

MeasureTime frameDescription
Levels of Ammonia (parts per billion) in response to an oral protein challenge using the Bedfont breath monitor5 hoursEvaluating change in breath ammonia at hour 5 compared to baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026