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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole grain rye bread | Experimental | 4.3 ounces of whole grain rye bread, consumed after an overnight fast (12+ hours) |
|
| Refined grain rye bread | Placebo Comparator | 4.3 ounces of white rye bread, consumed after an overnight fast (12+ hours) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole grain rye bread | Other | Single consumption of 4.3 oz of whole grain rye bread |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Physician-Diagnosed:
History of:
Currently:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brett R Loman, PhD, RD | Contact | 217-333-3451 | bloman2@illinois.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Urbana-Champaign | Recruiting | Urbana | Illinois | 61801 | United States |
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| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D002318 | Cardiovascular Diseases |
| D064806 | Dysbiosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomized, controlled, crossover
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Appearance, flavor, and texture of whole grain vs refined bread could not be masked
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| Refined grain rye bread | Other | Single consumption of 4.3 oz of refined grain rye bread |
|
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) |
| 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) |