Breath Analysis & Malnutrition (BAM-S)

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.

Study Overview

• Status: Recruiting
• Conditions: Malnutrition
• Intervention / Treatment: Other: Feeding; Other: Fasting

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 Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacob T Mey, PhD, RD; Phone Number: 225-763-2644; Email: jacob.mey@pbrc.edu

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Recruiting
      • Pennington Biomedical Research Center
      • Contact: Phone Number: 225-763-3000; Email: clinicaltrials@pbrc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Feeding; 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.	Other: Feeding; Nutrition beverages will be provided to meet the nutrient needs described in the Feeding Arm.
Experimental: Fasting; 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.	Other: Fasting; Water will be consumed as described during the Fasting Arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breath Ammonia	Breath ammonia (ppm)	Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breath volatile organic compounds	Untargeted mass spectrometry on breath volatile organic compound concentration in breath	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)	Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Investigators: Principal Investigator: Jacob Mey, PhD, RD, Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2023
• Primary Completion (Estimated): June 14, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: November 1, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: PBRC 2022-059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: External investigators may request additional data access, which will be shared according to institutional policy with appropriate data sharing agreements.
• IPD Sharing Time Frame: Upon reasonable request.
• IPD Sharing Access Criteria: According to institutional policy.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No