Actively Recruiting

Phase Not Applicable
Age: 18Years - 95Years
All Genders
Healthy Volunteers
ID06115148

Breath Ammonia as a Malnutrition Screening Tool

Led by Pennington Biomedical Research Center · Updated on 2026-01-21

12

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how breath markers relate to nutritional status, specifically focusing on malnutrition. This study compares breath molecules like ammonia and nitric oxide between people with and without malnutrition, using established nutrition screening tools and physical examinations. The goal is to find early signs of malnutrition through breath analysis combined with questionnaires. The study includes two parts: a cross-sectional comparison and an interventional trial with a subset of participants. In the interventional phase, participants are randomly assigned to either a feeding protocol, where they consume study beverages providing over 1.2 grams of protein per kilogram of bodyweight and 120% of energy needs every three hours during waking hours, or a fasting protocol, where they consume only water for 24 hours. Breath samples are collected before, during, and after these interventions to observe changes. Participants will undergo blood and breath sampling, complete questionnaires about their health and diet, and have a physical exam. Researchers will measure breath ammonia and volatile organic compounds upon waking, during interventions, and before bed. The study includes adults aged 18 to 95 years and monitors safety and adherence throughout. Participation may last for the duration of the intervention days and associated assessments.

CONDITIONS

Brief Title

Breath Analysis & Malnutrition

Who Can Participate

Age: 18Years - 95Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 95 years
  • Diagnosed with malnutrition for cross-sectional study participants not involved in intervention
Not Eligible

You will not qualify if you...

  • Chronic kidney, liver, or pulmonary disease
  • Use of anabolic steroids other than testosterone
  • Deemed unsuitable for enrollment by the study medical investigator
  • Pregnant or nursing women
  • Unable or unwilling to consume study beverages or fast for 24 hours during each arm

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Intervention

Duration - Each intervention lasts 1 day

Participants undergo both Feeding and Fasting protocols on separate days with breath samples collected before, during, and after each intervention to assess changes in breath molecules related to nutritional status.

2 visits (each intervention day, in-person)

Trial Site Locations

Total: 1 location

1

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States, 70808

Actively Recruiting

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Research Team

J

Jacob T Mey, PhD, RD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

2

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