Particle Size Project (EPSOM)

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.

Study Overview

• Status: Completed
• Conditions: Test if Increased Chewing Will Increased Microbiota SCFA Production
• Intervention / Treatment: Behavioral: Intervention

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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?

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control + Intervention; 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.	Behavioral: Intervention; Participants will have one week of increased chewing time (chew food until they reach an apple sauce consistency)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
• Change in short-chain fatty acid (SCFA) measured in stool samples by gas chromatography	1 week baseline and 1 week intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in median fecal particle size as measured by laser diffraction	1 week baseline and 1 week intervention
Change in gut microbiome composition as measured by 16S rRNA-encoding gene amplicon sequence analysis	1 week baseline and 1 week intervention

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Lawrence David, Duke University - MGM

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2021
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Pro00108805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No