Clinical trial NCT06687226: Food DNA Digestion
Official title: Digestion and Transit of Food DNA Through the Human Gut
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Digestion Rate
Keywords: Food
DNA
gut microbiome
transit time
digestion
digestive system
food DNA digestion
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Detailed description: 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.

Eligibility criteria: 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?

Primary outcomes:
measure: Transit time of naturally occurring food DNA through the human digestive tract
timeFrame: Approximately 5-8 days
Secondary outcomes:
measure: Rate of food DNA depletion
timeFrame: Approximately 5-8 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Medical Sciences Research Building III (MSRB III)
state: North Carolina
Study officials:
affiliation: Duke University
name: Lawrence David
role: PRINCIPAL_INVESTIGATOR
References: