Malnutrition
Conditions
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).
Interventions
OTHERFeeding
Nutrition beverages will be provided to meet the nutrient needs described in the Feeding Arm.
OTHERFasting
Water will be consumed as described during the Fasting Arm.
Sponsors
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The randomization scheme will be blinded to the PI and biostatistician. Due to the intervention (feeding vs fasting), the participant and other study staff cannot be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breath Ammonia | Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms | Breath ammonia (ppm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breath volatile organic compounds | 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 |
| Fractional Exhaled Nitric Oxide | Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms | Fractional exhaled nitric oxide (ppb) |
Countries
United States
Contacts
CONTACTJacob T Mey, PhD, RD
PRINCIPAL_INVESTIGATORJacob Mey, PhD, RD
Pennington Biomedical Research Center
Outcome results
None listed