Particle Size Project

NCT05091801 | Completed

• 1 other identifier: Pro00108805
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to test the effects of chewing efficiency on human gut microbiome composition and function.

Conditions

Test if Increased Chewing Will Increased Microbiota SCFA Production

Outcome Measures

Primary Outcomes (1)

• • Change in short-chain fatty acid (SCFA) measured in stool samples by gas chromatography

  1 week baseline and 1 week intervention

Secondary Outcomes (2)

• 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

Study Arms (1)

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.

Behavioral: Intervention

Interventions

Intervention BEHAVIORAL

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

Control + Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?

You may not qualify if:

• 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?

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27708, United States

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Lawrence David

  Duke University - MGM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 25, 2021
• Study Start: October 26, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: April 14, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)