Not Yet Recruiting

NCT Number: NCT06687226

Food DNA Digestion

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Digestion Rate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Sciences Research Building III (MSRB III)

Durham, North Carolina, 27710, United States

About this study

Transit time, the duration for ingested food to travel from ingestion to excretion, is crucial because it influences nutrient absorption, digestion efficiency, gut microbiome composition and the overall health of the gastrointestinal system. While numerous studies have focused on the breakdown of food components such as protein, fat and carbohydrates, the fate of food DNA, an integral part of the cells constituting these foods, remains less explored. Mouse studies indicate that food DNA can be traced in various sections of the digestive tract, with the greatest amount of degradation seen in the stomach. Human studies have supported these reports through showing significant dietary DNA degradation in the stomach and other food components in the stomach not significantly impact the efficiency of this degradation. However, this process is not 100% efficient as residual DNA has been shown to be detectable in stool in levels that are informative for health and epidemiological purposes. How long this residual DNA remains in the digestive tract and as such, the overall transit time and digestion rate for food DNA to be completely depleted from the digestive tract remain an open question.

In this study, the investigators will carry out a behavioral intervention in healthy human participants designed to investigate the transit time of dietary DNA. The design of this study is informed by the PI's previous experience with dietary interventions in human cohorts to better understand the human gut microbiome. This prior experience includes conducting a longitudinal study where samples as well as behavioral and dietary metadata were collected from human volunteers in addition to interventional studies of dietary supplements or fully controlled diets.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Above age 18?
Able to provide stool samples at no risk to the participant?
Does the participant have card access to the MSRBIII building, and is the participant able to visit this building (at times of the participant's convenience) for the purposes of this study?

Exclusion criteria

Already consume camu camu, maqui or kelp in typical diet?
Have a history or current diagnosis of irritable bowel syndrome?
Have a history or current diagnosis of inflammatory bowel disease?
Have a history or current diagnosis of type 2 diabetes?
Have a history or current diagnosis of chronic kidney disease with decreased kidney function?
Have a history or current diagnosis of intestinal obstruction?
Have a history or current diagnosis of untreated colorectal cancer?
Has the participant had a colonoscopy within the past month?

Treatment and study plan

Reconstitutable food powder

Dietary Supplement

During the intervention week, participants will be asked take one dose of a reconstitutable food powder provided in a ziplock bag. This powder will be a mix of Gatorade Zero Powder (1 serving) and 1 serving of commercially available powders of either one or all of the following: camu camu, kelp or maqui. The powder mix in the bag will be added to water and drunk by the participant as soon as possible after having a bowel movement (baseline stool sample). Food powders are sourced from reputable companies and are safe for consumption (Gatorade is a wellrecognized brand and available in grocery stores nationally, Navitas Organics provides certified organic, third-party tested plant food powders with fairtrade certification).

Primary outcomes

Transit time of naturally occurring food DNA through the human digestive tract

Time frame: Approximately 5-8 days

Determined by quantifying the presence of food DNA in stool samples over a specified period post-consumption.

Secondary outcomes

Rate of food DNA depletion

Time frame: Approximately 5-8 days

Evaluating the potential implications of the rate of food DNA depletion for nutrient absorption and gut microbiome interactions.

Study contacts

Contact information is provided by the study sponsor or research team.

Veronica M Carrion

CONTACT

[email protected]

919-660-7341

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Digestion and Transit of Food DNA Through the Human Gut

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Nov 13, 2024
Registry last updated: Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting

The Digestion of Protein Powders in Healthy Participants Using SIMBA and LIMBA Capsule

NCT06394687

Amino Acid Change, Congenital Abnormalities

Calgary, Alberta, Canada

View Trial Details