Test if Increased Chewing Will Increased Microbiota SCFA ProductionEPSOMNCT05091801
Particle Size Project
A study testing Intervention in people with Test if Increased Chewing Will Increased Microbiota SCFA Production, run by Duke University at 1 site in United States.
Trial summary
This study is designed to test the effects of chewing efficiency on human gut microbiome composition and function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Test if Increased Chewing Will Increased Microbiota SCFA Production
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2021to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 yourself?
- Do you have card access to the CIEMAS building (work in CIEMAS, in Pratt School, or undergraduate at Duke), and are you able to visit this building (at times of your own convenience) for the purposes of this study?
Who cannot join
- Oral antibiotic treatment within the past month?
- 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?
Show all 12Show fewer
- Have a history or current diagnosis of untreated colorectal cancer?
- Have you had a colonoscopy within the past month?
- Had oral antibiotics within the past month?
- Do you consume one entire non-snack meal or more per week in liquid form (smoothie, meal replacement drink, etc.)?
- Do you have any dental issues or other physical limitations that would prevent you from thoroughly chewing your food?
- Do you currently practice any mindfulness or dietary techniques that involve making sure that your food is chewed thoroughly?
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Increased Chewing Efficiency on the Gut Microbiome
This study is designed to test the effects of chewing efficiency on human gut microbiome composition and function.
Read the detailed description
Our working hypothesis is that increased chewing will lead to an increase in short-chain fatty acid production We further expect this effect to lead to a detectable decrease in fecal particle size and distinct changes in gut microbial community composition. Here, we will explore this hypothesis using a fixed-order within-subjects study design in a group of healthy participants. Each participant will have one week of normal dietary habits and one week of increased chewing time. We will collect stool samples three times per week in order to measure microbial abundance and metabolism.
- Being tested
- Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Participants will have one week of increased chewing time (chew food until they reach an apple sauce consistency)
| Study group | Role | What they receive |
|---|---|---|
| Control + Intervention | Experimental | We will explore our hypothesis using a fixed-order within-subjects study design in a group of healthy participants. Each participant will have one week of normal dietary habits and one week of increased chewing time. We will collect stool samples three times per week in order to measure microbial abundance and metabolism. Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Change in short-chain fatty acid (SCFA) measured in stool samples by gas chromatography
Measured: 1 week baseline and 1 week intervention
Secondary outcomes (2)
Change in median fecal particle size as measured by laser diffraction
Measured: 1 week baseline and 1 week intervention
Change in gut microbiome composition as measured by 16S rRNA-encoding gene amplicon sequence analysis
Measured: 1 week baseline and 1 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start26 Oct 2021
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Test if Increased Chewing Will Increased Microbiota SCFA ProductionStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence David, Principal investigator, Duke University - MGM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091801
- Sponsor's protocol ID
- Pro00108805
- Acronym
- EPSOM
- Status last verified
- Sep 2021
- First submitted
- 13 Oct 2021
- Last updated
- 14 Apr 2022
- Results posted
- 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 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Increased Chewing Efficiency on the Gut Microbiome
- ClinicalTrials.gov ID
- NCT05091801
- Acronym / sponsor ID
- EPSOM / Pro00108805
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 25 Oct 2021 (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 study is designed to test the effects of chewing efficiency on human gut microbiome composition and function.
Detailed description
Our working hypothesis is that increased chewing will lead to an increase in short-chain fatty acid production We further expect this effect to lead to a detectable decrease in fecal particle size and distinct changes in gut microbial community composition. Here, we will explore this hypothesis using a fixed-order within-subjects study design in a group of healthy participants. Each participant will have one week of normal dietary habits and one week of increased chewing time. We will collect stool samples three times per week in order to measure microbial abundance and metabolism.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control + Intervention | Experimental | Behavioral: InterventionWe will explore our hypothesis using a fixed-order within-subjects study design in a group of healthy participants. Each participant will have one week of normal dietary habits and one week of increased chewing time. We will collect stool samples three times per week in order to measure microbial abundance and metabolism. |
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 yourself?
- Do you have card access to the CIEMAS building (work in CIEMAS, in Pratt School, or undergraduate at Duke), and are you able to visit this building (at times of your own convenience) for the purposes of this study?
Key exclusion criteria (12 listed)
- Oral antibiotic treatment within the past month?
- 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 |
|---|---|---|
| InterventionParticipants will have one week of increased chewing time (chew food until they reach an apple sauce consistency) | Behavioural | Control + Intervention |
Primary outcome
• Change in short-chain fatty acid (SCFA) measured in stool samples by gas chromatography
Time frame: 1 week baseline and 1 week intervention
2 secondary outcomes
Change in median fecal particle size as measured by laser diffraction
Time frame: 1 week baseline and 1 week intervention
Change in gut microbiome composition as measured by 16S rRNA-encoding gene amplicon sequence analysis
Time frame: 1 week baseline and 1 week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Lawrence David principal investigator
Duke University - MGM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Test if Increased Chewing Will Increased Microbiota SCFA Production, 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 12 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: finished, as of the sponsor's last update on 14 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Change in short-chain fatty acid (SCFA) measured in stool samples by gas chromatography (time frame: 1 week baseline and 1 week intervention). 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 14 Apr 2022.