Breath Analysis & Malnutrition

Malnutrition Clinical Trial

— BAM-S  

Official title:

Breath Ammonia as a Malnutrition Screening Tool

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06115148
• Other study ID #: PBRC 2022-059
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2023
• Source: Pennington Biomedical Research Center
• Contact: Jacob T Mey, PhD, RD
• Phone: 225-763-2644
• Email: jacob.mey[@]pbrc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 30, 2024
• Est. primary completion date: June 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

Other:
• Feeding
Nutrition beverages will be provided to meet the nutrient needs described in the Feeding Arm.
• Fasting
Water will be consumed as described during the Fasting Arm.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breath Ammonia	Breath ammonia (ppm)	Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms
Secondary	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
Secondary	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