Food DNA Digestion

NCT06687226 | Not Yet Recruiting

• 1 other identifier: Pro00115407
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Digestion Rate

Keywords

Food; DNA; gut microbiome; transit time; digestion; digestive system; food DNA digestion

Outcome Measures

Primary Outcomes (1)

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

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

  Approximately 5-8 days

Secondary Outcomes (1)

• Rate of food DNA depletion

  Approximately 5-8 days

Study Arms (1)

Stool samples + consumption of powdered food

OTHER

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

Dietary Supplement: Reconstitutable food powder

Interventions

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).

Stool samples + consumption of powdered food

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?

You may not qualify if:

• 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?

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Medical Sciences Research Building III (MSRB III)

Durham, North Carolina, 27710, United States

Location

Study Officials

• Lawrence David

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronica M Carrion

CONTACT

919-660-7341; vmp19@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 13, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)