Digestion RateAnna BauerNCT06687226
Food DNA Digestion
A study testing Reconstitutable food powder in people with Digestion Rate, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Digestion Rate
- What is being tested?
- Reconstitutable food powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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?
Who cannot join
- 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?
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Medical Sciences Research Building III (MSRB III)
Durham, North Carolina, 27710
About this study
Official title: Digestion and Transit of Food DNA Through the Human Gut
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.
Read the 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.
- Conditions
- Digestion Rate
- Being tested
- Reconstitutable food powder
- Keywords
- Food, DNA, gut microbiome, transit time, digestion, digestive system, food DNA digestion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reconstitutable food powderDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Reconstitutable food powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 5-8 days
Secondary outcomes (1)
Rate of food DNA depletion
Evaluating the potential implications of the rate of food DNA depletion for nutrient absorption and gut microbiome interactions.
Measured: Approximately 5-8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start1 Jan 2027 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestion RateStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence David, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687226
- Sponsor's protocol ID
- Pro00115407
- Acronym
- Anna Bauer
- Status last verified
- Aug 2026
- First submitted
- 12 Nov 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digestion and Transit of Food DNA Through the Human Gut
- ClinicalTrials.gov ID
- NCT06687226
- Acronym / sponsor ID
- Anna Bauer / Pro00115407
- Conditions
- Digestion Rate
- Keywords
- Food, DNA, gut microbiome, transit time, digestion, digestive system, food DNA digestion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stool samples + consumption of powdered food | Other | Dietary Supplement: Reconstitutable food powderEach 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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?
Key exclusion criteria (8 listed)
- 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?
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reconstitutable food powderDuring 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). | Dietary supplement | Stool samples + consumption of powdered food |
Primary outcome
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.
1 secondary outcome
Rate of food DNA depletion
Time frame: Approximately 5-8 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lawrence David principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reconstitutable food powder in people with Digestion Rate, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veronica M Carrion (919-660-7341, vmp19@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transit time of naturally occurring food DNA through the human digestive tract (time frame: Approximately 5-8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.