Breath Analysis & Malnutrition

NCT06115148 | Recruiting

• 1 other identifier: PBRC 2022-059
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

• Breath Ammonia

  Breath ammonia (ppm)

  Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms

Secondary Outcomes (2)

• Breath volatile organic compounds

  Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms

• Fractional Exhaled Nitric Oxide

  Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms

Study Arms (2)

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.

Other: Feeding

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.

Other: Fasting

Interventions

Feeding OTHER

Nutrition beverages will be provided to meet the nutrient needs described in the Feeding Arm.

Feeding

Fasting OTHER

Water will be consumed as described during the Fasting Arm.

Fasting

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

RECRUITING

MeSH Terms

Conditions

Malnutrition

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Jacob Mey, PhD, RD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob T Mey, PhD, RD

CONTACT

225-763-2644; jacob.mey@pbrc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Research

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 2, 2023
• Study Start: August 17, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 21, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Upon reasonable request.
• Access Criteria: According to institutional policy.

Locations

US (1)