Clinical Trial

Food DNA Digestion

Study acronym: Anna Bauer
Not Yet Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2027-07-01 -> 2027-12-01 2026-08-08
minor Completion pushed: 2027-07-01 -> 2027-12-01 2026-08-08
Trial Details
NCT Number NCT06687226
Lead Sponsor Duke University
Conditions Digestion Rate
Enrollment 20 participants
Start Date 2027-01-01
Primary Completion 2027-12-01 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-07