Personalized GI Motility Responses to Diet
Purpose
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
Eligibility
- Eligible Ages
- Between 21 Years and 63 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- Randomized, controlled, crossover
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
- Masking Description
- Appearance, flavor, and texture of whole grain vs refined bread could not be masked
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Whole grain rye bread |
4.3 ounces of whole grain rye bread, consumed after an overnight fast (12+ hours) |
|
|
Placebo Comparator Refined grain rye bread |
4.3 ounces of white rye bread, consumed after an overnight fast (12+ hours) |
|
Recruiting Locations
Urbana, Illinois 61801
Brett R Loman, PhD, RD
More Details
- NCT ID
- NCT06386471
- Status
- Recruiting
- Sponsor
- University of Illinois at Urbana-Champaign