Breath Analysis & Malnutrition

Study Overview
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Brief Summary
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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
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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).

Official Title
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Breath Ammonia as a Malnutrition Screening Tool

Conditions
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Malnutrition

Intervention / Treatment
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* Other: Feeding
* Other: Fasting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-95 years Malnutrition group (Cross-sectional study only); not involved in intervention: Diagnosed with malnutrition (verified in medical history) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feeding<br>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<br>* Nutrition beverages will be provided to meet the nutrient needs described in the Feeding Arm.<br>|
| Experimental: Fasting<br>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<br>* Water will be consumed as described during the Fasting Arm.<br>|

What is the study measuring?
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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 |