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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feeding | Experimental | 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. |
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| Fasting | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feeding | Other | Nutrition beverages will be provided to meet the nutrient needs described in the Feeding Arm. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacob T Mey, PhD, RD | Contact | 225-763-2644 | jacob.mey@pbrc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jacob Mey, PhD, RD | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Recruiting | Baton Rouge | Louisiana | 70808 | United States |
External investigators may request additional data access, which will be shared according to institutional policy with appropriate data sharing agreements.
Upon reasonable request.
According to institutional policy.
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C407088 | Angptl4 protein, mouse |
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The randomization scheme will be blinded to the PI and biostatistician. Due to the intervention (feeding vs fasting), the participant and other study staff cannot be blinded.
| Fasting | Other | Water will be consumed as described during the Fasting Arm. |
|
Fractional exhaled nitric oxide (ppb) |
| Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms |