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NCT Number: NCT06115148

Breath Analysis & Malnutrition

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.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location status: Recruiting

Location contact

CONTACT

[email protected]

225-763-3000

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Feeding

Other

Nutrition beverages will be provided to meet the nutrient needs described in the Feeding Arm.

Fasting

Other

Water will be consumed as described during the Fasting Arm.

Primary outcomes

  1. Breath Ammonia

    Time frame: Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms

    Breath ammonia (ppm)

Secondary outcomes

  1. Breath volatile organic compounds

    Time frame: Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms

    Untargeted mass spectrometry on breath volatile organic compound concentration in breath

  2. Fractional Exhaled Nitric Oxide

    Time frame: Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms

    Fractional exhaled nitric oxide (ppb)

Study contacts

Contact information is provided by the study sponsor or research team.

Jacob T Mey, PhD, RD

CONTACT

[email protected]

225-763-2644

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

Breath Ammonia as a Malnutrition Screening Tool

Acronym: BAM-S

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 2, 2023
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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