Clinical trial NCT06115148: Breath Analysis & Malnutrition
Official title: Breath Ammonia as a Malnutrition Screening Tool
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malnutrition
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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).

Eligibility criteria: Inclusion Criteria:

1. Age: 18-95 years
2. Malnutrition group (Cross-sectional study only); not involved in intervention: Diagnosed with malnutrition (verified in medical history)

Exclusion Criteria:

1. Chronic kidney, liver or pulmonary disease
2. Anabolic steroid use other than testosterone (e.g., oxandrolone)
3. Patients judged unsuitable for enrollment by the study medical investigator
4. Pregnant women or women who are nursing
5. Unable or unwilling to consume study beverages or fast for 24 hours each arm

Primary outcomes:
measure: Breath Ammonia
timeFrame: Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms
Secondary outcomes:
measure: Breath volatile organic compounds
timeFrame: Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms
measure: Fractional Exhaled Nitric Oxide
timeFrame: Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Jacob Mey, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: