Food Powder for Metabolism

Overseen By Veronica M Carrion

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Irritable bowel, Inflammatory bowel, Diabetes, others

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

Compensation: Varies

Number of Visits: 1

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This pilot study investigates the digestion rate of naturally occurring food DNA through the human digestive tract by detecting residual food DNA in stool samples. The investigators hypothesize that food DNA primarily transits through the digestive system within 24 hours, with maximal detection in stool samples collected the day after ingestion. Previous research has focused on food DNA digestion in human gastric juices, leaving digestion through the entire gut largely unexplored. This study employs a fixed-order within subjects design involving healthy participants. Each participant will submit a baseline stool sample, consume a single dose of a study-specific powdered food (reconstituted in water) differing from their usual diet, and provide the subsequent five stool samples. If five samples are collected in fewer than five days, an additional sample will be obtained on the fifth day post-consumption. The presence and decline of food specific DNA in these samples will be quantified using qPCR, enabling us to determine the digestion rate of food DNA. The study design poses with minimal risk as it non-invasively monitors the natural process of food DNA digestion and transit through stool sample analysis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on diet and stool sample collection, so it's likely you can continue your medications, but you should confirm with the study team.

What data supports the effectiveness of the treatment Reconstitutable food powder for metabolism?

Research on ready-to-use therapeutic foods (RUTFs), which are similar to reconstitutable food powders, shows they are effective in treating malnutrition by providing high energy and nutrients. This suggests that reconstitutable food powders might also help improve metabolism by offering essential nutrients efficiently. ^{1 2 3 4 5}

How does the reconstitutable food powder treatment differ from other treatments for metabolism issues?

The reconstitutable food powder treatment is unique because it can be formulated with functional or beneficial compounds, such as dietary fibers and antioxidants, to provide health benefits. Unlike traditional treatments, this powder can be reconstituted into a colloidal suspension, offering a flexible and potentially healthier option for addressing metabolism issues. ^{6 7 8 9 10}

Research Team

Lawrence David

Principal Investigator

Duke University

Eligibility Criteria

This trial is for healthy individuals interested in helping to understand how food DNA moves through the digestive system. Participants will need to provide stool samples after consuming a special powdered food that's different from their usual diet.

Inclusion Criteria

I am over 18 years old.

Have card access to the MSRBIII building and able to visit at times of your own convenience for the study

Able to provide stool samples at no risk to yourself

Exclusion Criteria

I have or had colorectal cancer that has not been treated.

I have been diagnosed with or have a history of irritable bowel syndrome.

I have or had inflammatory bowel disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Sample Collection

Participants submit a baseline stool sample before consuming the study-specific powdered food

1 day

1 visit (in-person)

Intervention

Participants consume a single dose of a study-specific powdered food and provide subsequent stool samples

5-8 days

Daily sample collection

Follow-up

Participants are monitored for the presence and decline of food-specific DNA in stool samples

5-8 days

Treatment Details

Interventions

• Reconstitutable food powder

Trial Overview The study tests how quickly food DNA can be detected and declines in stool samples after eating reconstitutable food powder. It involves taking one dose of the powder, followed by submitting several stool samples over five days.

Participant Groups

Group I: Stool samples + consumption of powdered food Experimental Treatment 1 Intervention

Each participant will submit a baseline stool sample, consume a single dose of a study-specific powdered food (reconstituted in water) differing from their usual diet, and provide the subsequent five stool samples. If five samples are collected in fewer than five days, an additional sample will be obtained on the fifth day post-consumption

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

A study involving 650 patients with chronic conditions found that receiving medically tailored meals (MTM) for 2 weeks led to a significant reduction in anxiety and depression scores compared to baseline, while the 4-week group did not show similar improvements.

However, there were no significant differences in overall patient outcomes, such as activities of daily living, nutritional risk, or rates of emergency department visits and rehospitalizations, between the 2-week and 4-week MTM groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing two durations of medically tailored meals posthospitalization: A randomized clinical trial. Boxer, R., Drace, ML., Kelly, C., et al.[2023]

In a study involving 906 children with uncomplicated severe acute malnutrition, locally prepared ready-to-use therapeutic food (RUTF-L) showed a significantly higher recovery rate of 56.9% compared to 42.8% for augmented energy-dense home-prepared foods (A-HPF).

Both RUTF-L and centrally produced RUTF (RUTF-C) led to faster recovery times and greater weight gain than A-HPF, indicating that RUTF-L is a more effective option for home management of severe acute malnutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of three feeding regimens for home-based management of children with uncomplicated severe acute malnutrition: a randomised trial in India. Bhandari, N., Mohan, SB., Bose, A., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Optimizing Ready-to-Use Therapeutic Foods for Protein Quality, Cost, and Acceptability. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of preventive supplementation with ready-to-use therapeutic food on the nutritional status, mortality, and morbidity of children aged 6 to 60 months in Niger: a cluster randomized trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Comparing two durations of medically tailored meals posthospitalization: A randomized clinical trial. [2023]

4. Iran pubmed.ncbi.nlm.nih.gov

Ready-to-Use Therapeutic Food (RUTF) Formulations with Functional Food and Nutrient Density for the Treatment of Malnutrition in Crisis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy of three feeding regimens for home-based management of children with uncomplicated severe acute malnutrition: a randomised trial in India. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Ingredients, structure and reconstitution properties of instant powder foods and the potential for healthy product development: a comprehensive review. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Phytochemical profile of commercially available food plant powders: their potential role in healthier food reformulations. [2018]

8. Brazil pubmed.ncbi.nlm.nih.gov

[Influence of proles vegetable enzymes on meat]. [2006]

9. United States pubmed.ncbi.nlm.nih.gov

Developing food supplements for moderately malnourished children: lessons learned from ready-to-use therapeutic foods. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Development of a dehydrated fortified food base from fermented milk and parboiled wheat, and comparison of its composition and reconstitution behavior with those of commercial dried dairy-cereal blends. [2023]