Clinical trial NCT05091801: Particle Size Project
Official title: Effects of Increased Chewing Efficiency on the Gut Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Test if Increased Chewing Will Increased Microbiota SCFA Production
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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?

Primary outcomes:
measure: • Change in short-chain fatty acid (SCFA) measured in stool samples by gas chromatography
timeFrame: 1 week baseline and 1 week intervention
Secondary outcomes:
measure: Change in median fecal particle size as measured by laser diffraction
timeFrame: 1 week baseline and 1 week intervention
measure: Change in gut microbiome composition as measured by 16S rRNA-encoding gene amplicon sequence analysis
timeFrame: 1 week baseline and 1 week intervention
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University - MGM
name: Lawrence David
role: PRINCIPAL_INVESTIGATOR
References: