Clinical trial NCT06386471: Personalized GI Motility Responses to Diet
Official title: Personalized Gastrointestinal Motility Responses to Dietary Fiber and Gut Microbial Metabolites
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nutritional and Metabolic Diseases
Gastrointestinal Dysfunction
Cardiovascular Diseases
Dysbiosis
Keywords: dietary fiber
gastrointestinal motility
cardiometabolic
microbiome
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, controlled, crossover
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Gastrointestinal Pressure (mmHg)
timeFrame: 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)
measure: Luminal pH (pH units)
timeFrame: 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)
measure: Temperature (degrees celcius)
timeFrame: 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)
measure: Gastrointestinal Transit Time (hours:minutes)
timeFrame: 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)
measure: Blood Glucose
timeFrame: 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)
measure: Triglycerides
timeFrame: 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)
measure: Total Cholesterol
timeFrame: 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)
measure: HDL cholesterol
timeFrame: 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)
measure: LDL cholesterol
timeFrame: 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)
measure: Lipopolysaccharide Binding Protein
timeFrame: 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 outcomes:
measure: Microbiome
timeFrame: Fecal sample following ingestion of the Smartpill and test meal (approximately 24 hours into the study arm)
measure: Metabolomics
timeFrame: Fecal sample following ingestion of the Smartpill and test meal (approximately 24 hours into the study arm)
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
References: