Breath Analysis & Malnutrition
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Feeding, Fasting.
- Who it may be relevant to
- Registry conditions: Malnutrition. Basic parameters: 18 years — 95 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Breath Ammonia as a Malnutrition Screening Tool
Overview
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).
Interventions
- 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.
Primary outcome measures
- Breath Ammonia [Time frame: Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms]
Secondary outcome measures (2)
- Breath volatile organic compounds [Time frame: Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms]
- Fractional Exhaled Nitric Oxide [Time frame: Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Pennington Biomedical Research Center — Baton Rouge
Identifiers
NCT: NCT06115148 · PBRC 2022-059