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Breath Analysis for Malnutrition (BAM-S Trial)

N/A

Recruiting

Led By Jacob Mey, PhD, RD

Research Sponsored by Pennington Biomedical Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: 18-95 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up interventional: upon waking and after the intervention, but before bed on each of the 1-day intervention arms

Awards & highlights

BAM-S Trial Summary

This trial studies how breath is related to nutritional status by collecting breath and blood samples, health info, and physical exams. Some participants will also do an interventional study to see how breath changes with nutritional status.

Who is the study for?

This trial is for adults aged 18-95 with diagnosed malnutrition, who are not pregnant or nursing, and do not have chronic kidney, liver, or lung diseases. Participants must be willing to consume study beverages and fast as required.Check my eligibility

What is being tested?

The study aims to understand the relationship between breath composition and nutritional status by comparing breath markers in malnourished individuals against those without malnutrition. It includes a short-term intervention with special beverages and fasting to observe changes in breath.See study design

What are the potential side effects?

There may be minimal side effects from consuming the study beverages or from fasting such as lightheadedness, hunger pangs, or gastrointestinal discomfort. Blood sampling could cause slight pain or bruising.

BAM-S Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 95 years old.

BAM-S Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ interventional: upon waking and after the intervention, but before bed on each of the 1-day intervention arms

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~interventional: upon waking and after the intervention, but before bed on each of the 1-day intervention arms

This trial's timeline: 3 weeks for screening, Varies for treatment, and interventional: upon waking and after the intervention, but before bed on each of the 1-day intervention arms for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Breath Ammonia

Secondary outcome measures

Breath volatile organic compounds

Fractional Exhaled Nitric Oxide

BAM-S Trial Design

2Treatment groups

Experimental Treatment

Group I: FeedingExperimental Treatment1 Intervention

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 II: FastingExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Pennington Biomedical Research CenterLead Sponsor

305 Previous Clinical Trials

182,024 Total Patients Enrolled

Jacob Mey, PhD, RDPrincipal InvestigatorPennington Biomedical Research Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project recruiting participants over the age of fifty-five?

"This research is seeking participants aged 18 and above, but no older than 95."

Answered by AI

Who meets the criteria to participate in this clinical investigation?

"The requirements for enrolment in this medical study are to be between 18 and 95 years old with a diagnosis of malnutrition. Furthermore, 12 individuals must take part in the trial."

Answered by AI

What is the upper limit of participants taking part in this clinical experiment?

"Affirmative. Clinicaltrials.gov displays that this biomedical research is presently accepting volunteers, having initially been posted on August 17th 2023 and most recently modified on November 1st 2023. The trial is looking to recruit a dozen participants across one site."

Answered by AI

Are there any vacancies available for participants in the trial?

"According to the clinicaltrials.gov registry, this clinical trial is currently seeking patients for enrollment. The study was first created on August 17th 2023 and has most recently been adjusted on November 1st 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Breath Analysis & Malnutrition

Jacob T. Mey, PhD RD 2023. "Breath Analysis & Malnutrition". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06115148.

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