Breath Analysis & Malnutrition
ConditionMalnutrition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-95
SponsorPennington Biomedical Research Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age: 18-95 years
Malnutrition group (Cross-sectional study only); not involved in intervention: Diagnosed with malnutrition (verified in medical history)
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Feeding
Other interventionNutrition beverages will be provided to meet the nutrient needs described in the Feeding Arm.
Fasting
Other interventionWater will be consumed as described during the Fasting Arm.
Treatment groups
12 Participants
are divided into 2 treatment groupsGroup A: FeedingExperimental treatment 1 intervention
Group B: FastingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Breath Ammonia
Breath ammonia (ppm)
Time frame
Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention armsSecondary outcomes
1
Breath volatile organic compounds
Untargeted mass spectrometry on breath volatile organic compound concentration in breath
Time frame
Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms2
Fractional Exhaled Nitric Oxide
Fractional exhaled nitric oxide (ppb)
Time frame
Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention armsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov