Apply to Trial

Compensation: Varies

Number of Visits: 3

12 Participants Needed

Breath Analysis for Malnutrition
(BAM-S Trial)

Overseen ByJacob T Mey, PhD, RD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

Must not be taking: Anabolic steroids

Disqualifiers: Chronic kidney, liver, pulmonary, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude those using anabolic steroids other than testosterone.

What data supports the effectiveness of the treatment Fasting, Intermittent Fasting, Continuous Calorie Energy Reduction (CER), Weight Loss Interventions, Feeding for malnutrition?

The research highlights the importance of accurately determining caloric needs to optimize nutrition therapy, which can improve patient outcomes. This suggests that careful management of calorie intake, as seen in treatments like Continuous Calorie Energy Reduction (CER), may be beneficial in addressing malnutrition.¹ ² ³ ⁴ ⁵

Is continuous nasoenteric feeding safe for humans?

Continuous nasoenteric feeding in humans has been studied and found to have similar nutrient absorption and protein balance compared to intermittent feeding, with some differences in weight and mineral balances. It is generally safe, but there may be fluid and mineral shifts that need monitoring.³ ⁶ ⁷ ⁸ ⁹

How does the breath analysis treatment for malnutrition differ from other treatments?

The breath analysis treatment for malnutrition is unique because it uses the measurement of exhaled carbon stable isotope ratios to detect changes in energy balance and substrate utilization, providing real-time feedback on metabolic shifts. This non-invasive approach differs from traditional methods that often rely on more invasive or indirect measures to assess nutritional status.¹⁰ ¹¹ ¹² ¹³ ¹⁴

What is the purpose of this trial?

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 Team

Jacob Mey, PhD, RD

Principal Investigator

Pennington Biomedical Research Center

Eligibility Criteria

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.

Inclusion Criteria

You have been clinically diagnosed as suffering from malnutrition, according to your medical records.

Exclusion Criteria

Unable or unwilling to consume study beverages or fast for 24 hours each arm

I have not used any anabolic steroids except for testosterone.

I have a long-term kidney, liver, or lung disease.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cross-sectional Study

Participants undergo blood and breath sampling, questionnaires, and a physical examination to assess nutritional status

1 day

1 visit (in-person)

Interventional Study

Participants undergo either a feeding or fasting protocol to assess changes in breath markers

2 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

Fasting
Feeding

Trial Overview 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.

Participant Groups

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.