Cardiovascular Diseases, Dysbiosis, Gastrointestinal Dysfunction, Nutritional and Metabolic Diseases
Conditions
Keywords
dietary fiber, gastrointestinal motility, cardiometabolic, microbiome
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.
Interventions
Single consumption of 4.3 oz of whole grain rye bread
OTHERRefined grain rye bread
Single consumption of 4.3 oz of refined grain rye bread
Sponsors
University of Illinois at Urbana-Champaign
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Appearance, flavor, and texture of whole grain vs refined bread could not be masked
Intervention model description
Randomized, controlled, crossover
Eligibility
Sex/Gender
ALL
Age
21 Years to 63 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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) |
| 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 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 |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Contacts
Primary ContactBrett R Loman, PhD, RD
Outcome results
None listed