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NCT06115148NARecruitingAccepts Healthy Volunteers

Breath Analysis & Malnutrition

Pennington Biomedical Research Center

Start Date

8/17/2023

Completion Date

12/30/2026

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.

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).

Eligibility Criteria

Age Range: 18 years to 95 years

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

Interventions

OTHER

Feeding

OTHER

Fasting

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Conditions

Malnutrition

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana 70808

United States