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Particle Size Project

Effects of Increased Chewing Efficiency on the Gut Microbiome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05091801
Acronym
EPSOM
Enrollment
41
Registered
2021-10-25
Start date
2021-10-26
Completion date
2022-04-01
Last updated
2022-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Test if Increased Chewing Will Increased Microbiota SCFA Production

Brief summary

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.

Interventions

BEHAVIORALIntervention

Participants will have one week of increased chewing time (chew food until they reach an apple sauce consistency)

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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?

Exclusion criteria

* 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? * 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?

Design outcomes

Primary

MeasureTime frame
• Change in short-chain fatty acid (SCFA) measured in stool samples by gas chromatography1 week baseline and 1 week intervention

Secondary

MeasureTime frame
Change in median fecal particle size as measured by laser diffraction1 week baseline and 1 week intervention
Change in gut microbiome composition as measured by 16S rRNA-encoding gene amplicon sequence analysis1 week baseline and 1 week intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026