Personalized GI Motility Responses to Diet

April 23, 2024 updated by: University of Illinois at Urbana-Champaign

Personalized Gastrointestinal Motility Responses to Dietary Fiber and Gut Microbial Metabolites

The goal of this randomized, crossover, clinical trial is to link: 1) gastrointestinal motility patterns induced by acute consumption of whole and refined grains, 2) enteric microbial production of bioactive metabolites, and 3) circulating postprandial appearance of metabolites important to cardiometabolic health including glucose, triglycerides, and cholesterol.

Participants will be asked to consume a Smartpill monitoring device that records metrics of gastrointestinal motility in response to whole or refined grains, monitor cardiometabolic metabolties over an 8 hour postprandial window, and provide a fecal sample for microbiome-related analyses.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • University of Illinois at Urbana-Champaign
        • Contact:
          • Brett R Loman, PhD, RD
        • Principal Investigator:
          • Brett R Loman, PhD, RD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy men and women

Exclusion Criteria:

Physician-Diagnosed:

  • Diabetes Mellitus
  • Nutrient-malabsorption disorders
  • Intestinal Bowel Syndrome (IBS)
  • Intestinal Bowel Disease (IBD)
  • Bleeding-related disorders
  • Grain allergy
  • Psychological Disorders
  • Stenosis
  • Dysphasia

History of:

  • Bariatric Surgery
  • Gallbladder removal
  • Eating disorders
  • Antibiotic administration (within the past three months)
  • Hormone therapy

Currently:

  • Using statins
  • Pregnant, lactating, or postmenopausal
  • Taking oral hypoglycemic agents or insulin
  • Ingesting prescription fiber
  • Using cholesterol and bile acid absorption inhibitors
  • Ingesting nutrition supplements, not including a daily multivitamin (i.e. herbs, tinctures, and extracts) •Using recreational drugs or alcohol (within the past week)
  • Taking anti-histamines
  • Taking proton pump inhibitors
  • Taking antacids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whole grain rye bread
4.3 ounces of whole grain rye bread, consumed after an overnight fast (12+ hours)
Other: Whole grain rye bread
Single consumption of 4.3 oz of whole grain rye bread
Placebo Comparator: Refined grain rye bread
4.3 ounces of white rye bread, consumed after an overnight fast (12+ hours)
Other: Refined grain rye bread
Single consumption of 4.3 oz of refined grain rye bread

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal Pressure (mmHg)
Time Frame: From consumption of bread and Smartpill to deification (single meal consumption, GI motility times vary based on participant, but could be estimated from around 16 hours to 5 days)
Pressure of gastrointestinal contractions as captured by the Medtronic Smartpill capsule temperature, transit time)
From consumption of bread and Smartpill to deification (single meal consumption, GI motility times vary based on participant, but could be estimated from around 16 hours to 5 days)
Luminal pH (pH units)
Time Frame: From consumption of bread and Smartpill to deification (single meal consumption, GI motility times vary based on participant, but could be estimated from around 16 hours to 5 days)
pH of gastrointestinal contents as captured by the Medtronic Smartpill capsule
From consumption of bread and Smartpill to deification (single meal consumption, GI motility times vary based on participant, but could be estimated from around 16 hours to 5 days)
Temperature (degrees celcius)
Time Frame: From consumption of bread and Smartpill to deification (single meal consumption, GI motility times vary based on participant, but could be estimated from around 16 hours to 5 days)
Temperature in the intestinal lumen as captured by the Medtronic Smartpill capsule
From consumption of bread and Smartpill to deification (single meal consumption, GI motility times vary based on participant, but could be estimated from around 16 hours to 5 days)
Gastrointestinal Transit Time (hours:minutes)
Time Frame: From consumption of bread and Smartpill to deification (single meal consumption, GI motility times vary based on participant, but could be estimated from around 16 hours to 5 days)
Duration of gastrointestinal transit as captured by the Medtronic Smartpill capsule
From consumption of bread and Smartpill to deification (single meal consumption, GI motility times vary based on participant, but could be estimated from around 16 hours to 5 days)
Blood Glucose
Time Frame: Baseline to 8 hours post bread and Smartpill consumption (baseline, 0.5 hours, 1 hour, 1.5 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, and 8 hours)
Concentration of glucose in whole blood from finger prick as measured by the Konsung Portable Dry Biochemical Analyzer
Baseline to 8 hours post bread and Smartpill consumption (baseline, 0.5 hours, 1 hour, 1.5 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, and 8 hours)
Triglycerides
Time Frame: Baseline to 8 hours post bread and Smartpill consumption (baseline, 0.5 hours, 1 hour, 1.5 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, and 8 hours)
Concentration of triglycerides in whole blood from finger prick as measured by the Konsung Portable Dry Biochemical Analyzer
Baseline to 8 hours post bread and Smartpill consumption (baseline, 0.5 hours, 1 hour, 1.5 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, and 8 hours)
Total Cholesterol
Time Frame: Baseline to 8 hours post bread and Smartpill consumption (baseline, 0.5 hours, 1 hour, 1.5 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, and 8 hours)
Concentration of total cholesterol in whole blood from finger prick as measured by the Konsung Portable Dry Biochemical Analyzer
Baseline to 8 hours post bread and Smartpill consumption (baseline, 0.5 hours, 1 hour, 1.5 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, and 8 hours)
HDL cholesterol
Time Frame: Baseline to 8 hours post bread and Smartpill consumption (baseline, 0.5 hours, 1 hour, 1.5 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, and 8 hours)
Concentration of HDL cholesterol in whole blood from finger prick as measured by the Konsung Portable Dry Biochemical Analyzer
Baseline to 8 hours post bread and Smartpill consumption (baseline, 0.5 hours, 1 hour, 1.5 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, and 8 hours)
LDL cholesterol
Time Frame: Baseline to 8 hours post bread and Smartpill consumption (baseline, 0.5 hours, 1 hour, 1.5 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, and 8 hours)
Concentration of LDL choelsterol in whole blood from finger prick as measured by the Konsung Portable Dry Biochemical Analyzer
Baseline to 8 hours post bread and Smartpill consumption (baseline, 0.5 hours, 1 hour, 1.5 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, and 8 hours)
Lipopolysaccharide Binding Protein
Time Frame: Baseline to 8 hours post bread and Smartpill consumption (baseline, 0.5 hours, 1 hour, 1.5 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, and 8 hours)
Concentration of LBP in whole blood from finger prick as measured by ELISA
Baseline to 8 hours post bread and Smartpill consumption (baseline, 0.5 hours, 1 hour, 1.5 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, and 8 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiome
Time Frame: Fecal sample following ingestion of the Smartpill and test meal (approximately 24 hours into the study arm)
Shotgun metagenomic sequencing of fecal samples, including metrics of diversity (ex: shannon index), taxonomic abundances (relative abundance, %), functional gene abundances (relative abundance, %), etc
Fecal sample following ingestion of the Smartpill and test meal (approximately 24 hours into the study arm)
Metabolomics
Time Frame: Fecal sample following ingestion of the Smartpill and test meal (approximately 24 hours into the study arm)
Untargeted metabolomics of fecal samples via LC-MS, including metrics of pathway analysis (pathway score), single metabolite relative concentration (relative intensity), etc
Fecal sample following ingestion of the Smartpill and test meal (approximately 24 hours into the study arm)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Urbana-Champaign

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2024

Primary Completion (Estimated)

June 12, 2024

Study Completion (Estimated)

June 2, 2025

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

April 23, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24093

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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