Personalized GI Motility Responses to Diet

Cardiovascular Diseases Clinical Trial

Official title:

Personalized Gastrointestinal Motility Responses to Dietary Fiber and Gut Microbial Metabolites

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06386471
• Other study ID #: 24093
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2024
• Est. completion date: June 2, 2025

Study information

• Verified date: April 2024
• Source: University of Illinois at Urbana-Champaign
• Contact: Brett R Loman, PhD, RD
• Phone: 217-333-3451
• Email: bloman2[@]illinois.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2, 2025
• Est. primary completion date: June 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 63 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Dysbiosis
• Gastrointestinal Dysfunction
• Metabolic Diseases
• Nutritional and Metabolic Diseases

Intervention

Other:
• Whole grain rye bread
Single consumption of 4.3 oz of whole grain rye bread
• Refined grain rye bread
Single consumption of 4.3 oz of refined grain rye bread

Locations

Country	Name	City	State
United States	University of Illinois at Urbana-Champaign	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal Pressure (mmHg)	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)
Primary	Luminal pH (pH units)	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)
Primary	Temperature (degrees celcius)	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)
Primary	Gastrointestinal Transit Time (hours:minutes)	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)
Primary	Blood Glucose	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)
Primary	Triglycerides	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)
Primary	Total Cholesterol	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)
Primary	HDL cholesterol	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)
Primary	LDL cholesterol	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)
Primary	Lipopolysaccharide Binding Protein	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	Microbiome	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)
Secondary	Metabolomics	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)