Breath Analysis & Malnutrition

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-17

Study Completion Date

2026-12-30

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.

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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).

Conditions

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Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

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Feeding

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.

Group Type EXPERIMENTAL

Feeding

Intervention Type OTHER

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

Fasting

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.

Group Type EXPERIMENTAL

Fasting

Intervention Type OTHER

Water will be consumed as described during the Fasting Arm.

Interventions

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Feeding

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

Intervention Type OTHER

Fasting

Water will be consumed as described during the Fasting Arm.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes