Particle Size Project

Not Applicable

Completed

• Conditions: Test if Increased Chewing Will Increased Microbiota SCFA Production
• Interventions: Behavioral: Intervention

• Registration Number: NCT05091801
• Lead Sponsor: Duke University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-25
• Study Start: 2021-10-26
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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?

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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?

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control + Intervention	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States