MalnutritionBAM-SNCT06115148
Breath Analysis & Malnutrition
A study testing Feeding and Fasting in people with Malnutrition, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Feeding and Fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2023to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18-95 years
- Malnutrition group (Cross-sectional study only); not involved in intervention: Diagnosed with malnutrition (verified in medical history)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
225-763-3000, clinicaltrials@pbrc.edu
About this study
Official title: Breath Ammonia as a Malnutrition Screening Tool
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.
Read the 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).
- Conditions
- Malnutrition
- Being tested
- Feeding, Fasting
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeedingOther
Nutrition beverages will be provided to meet the nutrient needs described in the Feeding Arm.
FastingOther
Water will be consumed as described during the Fasting Arm.
| Study group | Role | What they receive |
|---|---|---|
| Feeding | Experimental | Participants will be instructed to consume study beverages to provide >1.2 grams of protein per kilogram bodyweight and >120% of total energy needs. Energy needs will be estimated by the Mifflin-St Jeor equation multiplied by an activity factor of 1.5. Study beverages will be a mix of meal replacement shakes e.g., Ensure (Abbott Laboratories, Chicago, IL, USA) products to accommodate protein and energy needs. Study beverages will be consumed every ~3 hours to induce a perpetually fed state. Feeding will occur during waking hours, typically between 7a-11p. Breath will be collected before, during and after the intervention. Receives: Other: Feeding |
| Fasting | Experimental | Participants will be instructed to consume only water during the duration of the Fasting Protocol. Regardless of the randomization sequence, participants will have consumed their last meal or study beverage by 11p the night prior. Breath will be collected before, during and after the intervention. Receives: Other: Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath Ammonia
Breath ammonia (ppm)
Measured: Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms
Secondary outcomes (2)
Breath volatile organic compounds
Untargeted mass spectrometry on breath volatile organic compound concentration in breath
Measured: Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms
Fractional Exhaled Nitric Oxide
Fractional exhaled nitric oxide (ppb)
Measured: Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start17 Aug 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob T. Mey, PhD RD, Pennington Biomedical Research Center
- Investigators
- Jacob Mey, PhD, RD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115148
- Sponsor's protocol ID
- PBRC 2022-059
- Acronym
- BAM-S
- Status last verified
- Dec 2025
- First submitted
- 24 Oct 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: External investigators may request additional data access, which will be shared according to institutional policy with appropriate data sharing agreements.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breath Ammonia as a Malnutrition Screening Tool
- ClinicalTrials.gov ID
- NCT06115148
- Acronym / sponsor ID
- BAM-S / PBRC 2022-059
- Conditions
- Malnutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feeding | Experimental | Other: FeedingParticipants will be instructed to consume study beverages to provide >1.2 grams of protein per kilogram bodyweight and >120% of total energy needs. Energy needs will be estimated by the Mifflin-St Jeor equation multiplied by an activity factor of 1.5. Study beverages will be a mix of meal replacement shakes e.g., Ensure (Abbott Laboratories, Chicago, IL, USA) products to accommodate protein and energy needs. Study beverages will be consumed every ~3 hours to induce a perpetually fed state. Feeding will occur during waking hours, typically between 7a-11p. Breath will be collected before, during and after the intervention. |
| Fasting | Experimental | Other: FastingParticipants will be instructed to consume only water during the duration of the Fasting Protocol. Regardless of the randomization sequence, participants will have consumed their last meal or study beverage by 11p the night prior. Breath will be collected before, during and after the intervention. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 18-95 years
- Malnutrition group (Cross-sectional study only); not involved in intervention: Diagnosed with malnutrition (verified in medical history)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FeedingNutrition beverages will be provided to meet the nutrient needs described in the Feeding Arm. | Other | Feeding |
| FastingWater will be consumed as described during the Fasting Arm. | Other | Fasting |
Primary outcome
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)
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Yes. External investigators may request additional data access, which will be shared according to institutional policy with appropriate data sharing agreements.
Related trials for Malnutrition
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
Recruiting
Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition
Acute Malnutrition With no Complications
Recruiting
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Severe Acute Malnutrition, Cognitive Impairment
Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
RecruitingPhase 4
Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
Malnutrition, Child, Malnutrition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacob Mey, PhD, RD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feeding and Fasting in people with Malnutrition, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacob T Mey, PhD, RD (225-763-2644, jacob.mey@pbrc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breath Ammonia (time frame: Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026; AzTrials last refreshed its copy on 28 Oct 2026.