Food Powder for Metabolism

VM
Overseen ByVeronica M Carrion
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the speed at which a special powdered food moves through the digestive system by detecting its DNA in stool samples. The aim is to determine if the food DNA primarily exits the body within a day after consumption. Participants will consume this reconstitutable food powder mixed with water and then provide stool samples for analysis. This trial suits healthy adults who can easily provide stool samples and do not already consume foods like camu camu, maqui, or kelp.

As an unphased trial, it allows participants to contribute to the scientific understanding of digestive 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. 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 prior data suggests that this food powder is safe?

Research has shown that the food powder used in this study is generally safe. In a study on instant tomato sauce powder, participants reported no negative reactions to the ingredients and consumed the powder without issues.

The food powder mixes easily with water and is designed for convenience and nutrition. Such products are common and usually well-tolerated.

Overall, previous studies have not shown any major safety concerns with this type of food powder. The study involves taking just one dose, making it a low-risk activity.12345

Why are researchers excited about this trial?

Unlike standard dietary interventions for metabolism, which often involve long-term dietary changes and supplements, this reconstitutable food powder offers a unique, single-dose approach. Researchers are excited because it provides a controlled way to assess the metabolic impact through stool sample analysis, allowing insights into gut microbiome interactions. This method could potentially reveal rapid, measurable effects on metabolism, offering a quicker and more targeted alternative to traditional methods.

What evidence suggests that this reconstitutable food powder is effective for studying food DNA digestion?

Research has shown that some DNA from food can pass through the digestive system and end up in stool. This study aims to track the speed and quantity of this food DNA digestion. The main idea is that most food DNA moves through the body and can be detected within about 24 hours. While previous studies have focused on food breakdown in the stomach, this study will examine the entire digestive process. Participants in this trial will consume a powdered food mixed with water, differing from their usual diet. The goal is to observe how quickly the food DNA appears and disappears in stool samples.13567

Who Is on the Research Team?

LD

Lawrence David

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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.
Able to provide stool samples at no risk to yourself
Have card access to the MSRBIII building and able to visit at times of your own convenience for the study

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.
See 5 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Stool samples + consumption of powdered foodExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

Published Research Related to This Trial

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

Citations

Reconstitutable instant tomato sauce powderThis study aimed to develop instant tomato sauce powder (ITSP) using whole tomatoes (ITSP-P1) and tomato puree (ITSP-P2).
Reconstitutable Instant Tomato Sauce Powder450. This study offers an efficient formula for tomato sauce powder and reconstituted tomato sauce, ... approaches for food analysis and food metabolomics.
Effect of honey powder concentration on physicochemical ...This study evaluated the effects of honey powder concentrations on physicochemical and sensory properties of spray-dried yogurt. A vacuum drying technique was ...
(PDF) Reconstitutable instant tomato sauce powderThis study aimed to develop instant tomato sauce powder (ITSP) using whole tomatoes (ITSP-P1) and tomato puree (ITSP-P2).
5.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38059502/
Ingredients, structure and reconstitution properties of ...This review proposed a new classification method for instant powder foods according to the solubility of ingredients and the structure of the reconstituted ...
Potentially Harmful Excipients: State of the Art for Oral ...The STEP database only contains data on silica exposure in adults, which has been associated with auto-immune vasculitis, esophageal, gastric ...
Ingredients, structure and reconstitution properties of ...Ingredients, structure and reconstitution properties of instant powder foods and the potential for healthy product development: A comprehensive review | ...
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