Cardiovascular Diseases Clinical Trial
Official title:
Personalized Gastrointestinal Motility Responses to Dietary Fiber and Gut Microbial Metabolites
NCT number | NCT06386471 |
Other study ID # | 24093 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 7, 2024 |
Est. completion date | June 2, 2025 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois at Urbana-Champaign | Urbana | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Urbana-Champaign |
United States,
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) |
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