Breath Analysis for Malnutrition

(BAM-S Trial)

Overseen By Jacob 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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the link between exhaled breath and nutritional health. Researchers compare breath samples from individuals with and without malnutrition to identify any noticeable differences. Some participants will either drink special shakes or fast as part of a weight loss intervention, and their breath will be tested for changes. The trial seeks individuals diagnosed with malnutrition who can fast or consume meal replacement shakes. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on nutritional health.

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 prior data suggests that the breath analysis method is safe for participants?

A previous study showed that alternate day fasting aids weight loss and improves metabolism, suggesting fasting can be safe for many. However, some studies note limited safety data for methods like Alternate Day Fasting (ADF). Caution is advised, especially for those with certain health conditions.

For the eating part of this study, research shows that meal replacement drinks like Ensure are generally safe and often help those needing more nutrition. These drinks provide the right amount of protein and calories. Studies have found that these supplements improve nutrition without major safety concerns.

Overall, both fasting and meal replacements have been used safely in other contexts. However, since each body is different, consider personal health and consult a healthcare provider before joining a study like this. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how our body's metabolic responses can be influenced by different eating patterns, specifically fasting and continuous feeding. Unlike traditional approaches to malnutrition that often focus solely on dietary intake improvements, this trial aims to understand the breath metabolic markers that could indicate nutritional status or deficiencies. By analyzing breath before, during, and after these interventions, scientists hope to uncover new, non-invasive ways to assess and potentially address malnutrition. This could lead to more personalized nutrition plans and better outcomes for individuals with nutritional challenges.

What evidence suggests that this trial's treatments could be effective for malnutrition?

This trial will compare two approaches: intermittent fasting and a feeding protocol using meal replacement products. Studies have shown that intermittent fasting, which involves not eating for certain periods, can aid weight loss and boost metabolism. Specifically, individuals who tried intermittent fasting lost between 0.8% to 13.0% of their starting weight without serious side effects. Participants in the fasting arm of this trial will follow a similar protocol.

For those in the feeding arm, research suggests that meal replacement products can help reduce weight and body fat. These products may also improve the balance of fat and muscle in the body and support better metabolic health. Both methods show promise for managing weight and improving overall health, though they operate differently. ^{6 7 8 9 10}

Who Is on the Research Team?

Jacob Mey, PhD, RD

Principal Investigator

Pennington Biomedical Research Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Feeding Experimental Treatment 1 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: Fasting Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Pennington Biomedical Research Center

Lead Sponsor

Trials

314

Recruited

183,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7021351/

Intermittent fasting and weight loss: Systematic review - PMC Intermittent fasting trials showed weight loss of 0.8% to 13.0% of baseline weight, with no serious adverse events, and shows promise for obesity treatment.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1658361225000186

Evaluation of the effectiveness of intermittent fasting versus ... Dietary interventions, particularly intermittent fasting (IF) and energy restriction (ER), have emerged as effective strategies for managing weight.

3. news.cuanschutz.edu news.cuanschutz.edu/news-stories/intermittent-fasting-outperforms-calorie-counting-in-weight-loss-study

4:3 Intermittent Fasting Outperforms Daily Calorie ... New study shows greater adherence and weight loss in a 4:3 intermittent fasting group compared with a traditional daily calorie restriction ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04526847

Intermittent Fasting Compared to Continuous Energy ... The primary outcome of this study will be the change in reduction of body weight between IER diet using 2-day severe energy-restricted with 5 days of ...

5. npjournal.org npjournal.org/article/S1555-4155%2823%2900395-1/fulltext

Intermittent Fasting: Exploring Approaches, Benefits, and ... Studies have shown that intermittent fasting can be an effective method for weight loss because it reduces overall calorie intake and increases metabolism.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9099935/

Intermittent Fasting versus Continuous Calorie Restriction Current guidelines recommend continuous calorie restriction (CCR; about 500 or 750 kcal of energy deficiency per day, or 30% of baseline energy ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523125172

Health effects of intermittent fasting: hormesis or harm? A ... This study did not evaluate subject safety outcomes. Safety data for ADF regimens are lacking, but ADF has been shown to not cause an increase in caloric intake ...

8. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1748-4

Intermittent versus continuous energy restriction on weight ... Both intermittent and continuous energy restriction achieved a comparable effect in promoting weight-loss and metabolic improvements.

9. bmj.com bmj.com/content/389/bmj.r1156

Intermittent fasting as a nutritional tool Randomised trials have shown that alternate day fasting can induce more substantial weight losses (around 4-6 kg in 8-12 weeks), accompanied by reductions in ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9946909/

Beneficial effects of intermittent fasting: a narrative review Intermittent fasting has beneficial effects equivalent to those of caloric restriction in terms of body weight control, improvements in glucose homeostasis and ...