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OpenTrials
Completed

NCT Number: NCT05091801

Particle Size Project

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27708, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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?

Treatment and study plan

Intervention

Behavioral

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

Primary outcomes

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

    Time frame: 1 week baseline and 1 week intervention

Secondary outcomes

  1. Change in median fecal particle size as measured by laser diffraction

    Time frame: 1 week baseline and 1 week intervention

  2. Change in gut microbiome composition as measured by 16S rRNA-encoding gene amplicon sequence analysis

    Time frame: 1 week baseline and 1 week intervention

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Effects of Increased Chewing Efficiency on the Gut Microbiome

Acronym: EPSOM

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 25, 2021
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.