Particle Size Project

NCT ID: NCT05091801

Last Updated: 2022-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-26
• Study Completion Date: 2022-04-01

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.

Conditions

Test if Increased Chewing Will Increased Microbiota SCFA Production

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Intervention

Intervention Type: BEHAVIORAL

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

Interventions

Intervention

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

Intervention Type: BEHAVIORAL

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?

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lawrence David

Role: PRINCIPAL_INVESTIGATOR

Duke University - MGM

Locations

Duke University

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00108805

Identifier Type: -

Identifier Source: org_study_id