Personalized GI Motility Responses to Diet
- Conditions
- Cardiovascular DiseasesDysbiosisGastrointestinal DysfunctionNutritional and Metabolic Diseases
- Interventions
- Other: Refined grain rye breadOther: Whole grain rye bread
- Registration Number
- NCT06386471
- Lead Sponsor
- University of Illinois at Urbana-Champaign
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Healthy men and women
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Refined grain rye bread Refined grain rye bread 4.3 ounces of white rye bread, consumed after an overnight fast (12+ hours) Whole grain rye bread Whole grain rye bread 4.3 ounces of whole grain rye bread, consumed after an overnight fast (12+ hours)
- Primary Outcome Measures
Name Time Method Luminal pH (pH units) 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
Temperature (degrees celcius) 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
Gastrointestinal Pressure (mmHg) 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)
Gastrointestinal Transit Time (hours:minutes) 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
Total Cholesterol 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
LDL cholesterol 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
Blood Glucose 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
Triglycerides 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
HDL cholesterol 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
Lipopolysaccharide Binding Protein 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
- Secondary Outcome Measures
Name Time Method Microbiome 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
Metabolomics 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
Trial Locations
- Locations (1)
University of Illinois at Urbana-Champaign
🇺🇸Urbana, Illinois, United States