Personalized GI Motility Responses to Diet

NCT06386471 | Recruiting

• 1 other identifier: 24093
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

dietary fiber; gastrointestinal motility; cardiometabolic; microbiome

Outcome Measures

Primary Outcomes (10)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (2)

• Microbiome

  Fecal sample following ingestion of the Smartpill and test meal (approximately 24 hours into the study arm)

• Metabolomics

  Fecal sample following ingestion of the Smartpill and test meal (approximately 24 hours into the study arm)

Study Arms (2)

Whole grain rye bread

EXPERIMENTAL

4.3 ounces of whole grain rye bread, consumed after an overnight fast (12+ hours)

Other: Whole grain rye bread

Refined grain rye bread

PLACEBO COMPARATOR

4.3 ounces of white rye bread, consumed after an overnight fast (12+ hours)

Other: Refined grain rye bread

Interventions

Whole grain rye bread OTHER

Single consumption of 4.3 oz of whole grain rye bread

Whole grain rye bread

Refined grain rye bread OTHER

Single consumption of 4.3 oz of refined grain rye bread

Refined grain rye bread

Eligibility Criteria

• Age: 21 Years - 63 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

RECRUITING

MeSH Terms

Conditions

Nutritional and Metabolic Diseases; Cardiovascular Diseases; Dysbiosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Brett R Loman, PhD, RD

CONTACT

217-333-3451; bloman2@illinois.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Appearance, flavor, and texture of whole grain vs refined bread could not be masked
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, crossover

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: April 26, 2024
• Study Start: March 7, 2024
• Primary Completion: June 12, 2024
• Study Completion: June 2, 2025
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

US (1)