NCT06115148

Breath Analysis & Malnutrition

Breath Ammonia as a Malnutrition Screening Tool

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Pennington Biomedical Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research study is to understand how breath is related to nutritional status. The procedures involved in this study include blood and breath sampling, questionnaires about health history, medications, nutritional status and diet, and a physical examination. Breath markers will be compared between individuals with and without malnutrition and be compared to indicators of malnutrition. Some individuals will undergo an interventional study involving 2 days of consuming study beverages and fasting along with providing additional breath samples to see if the breath changes in response to short-term changes in nutritional status.

Detailed description

Research Summary: This research involves a cross-sectional study investigating whether breath molecules (in particular ammonia and nitric oxide) are related to the presence and magnitude of malnutrition as measured by the gold-standard nutrition focused physical examination (NFPE). It also involves an interventional study in a subset of cross-sectional participants looking at whether acute changes in nutritional status through anabolic feeding protocols or fasting protocols is related to short term changes in breath molecules. Purpose of the Research: The purpose is to identify early evidence of breath biomarkers of malnutrition. It uses a combination of breath analysis and current malnutrition screening tools (questionnaires).

Conditions

• Malnutrition

Interventions

Type	Name	Description
OTHER	Feeding	Nutrition beverages will be provided to meet the nutrient needs described in the Feeding Arm.
OTHER	Fasting	Water will be consumed as described during the Fasting Arm.

Timeline

• Start date: 2023-08-17
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2023-11-02
• Last updated: 2026-01-21

Locations

1 site across 1 country: United States