Personalized GI Motility Responses to Diet

This study is looking at how your body responds to different types of rye bread. Researchers want to understand how eating whole grain rye bread versus refined grain rye bread affects your digestion (gastrointestinal motility), the helpful bacteria in your gut, and important measures for heart health like blood sugar and cholesterol. You might be able to join if you are a healthy adult between 21 and 63 years old. The study aims to enroll 50 participants. Success will be measured by changes in your gastrointestinal pressure, pH levels, and temperature after eating the bread. The study status is currently unclear.

Study design
This is a randomized, crossover clinical trial, meaning participants will try both types of bread at different times. The study plans to enroll 50 healthy men and women.
What's involved
You will consume a Smartpill monitoring device, eat either whole grain or refined grain rye bread, and provide a stool sample. Your cardiometabolic health will be monitored for 8 hours after eating.
Compensation
Not stated in the trial record.
Follow-up
Your gastrointestinal pressure, pH, and temperature will be measured from the time you consume the bread and Smartpill until you have a bowel movement, which could be 16 hours to 5 days later.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06386471

Personalized GI Motility Responses to Diet

UNKNOWN
NAAges 21–63InterventionalBasic science
University of Illinois at Urbana-Champaign
~50 participants
Updated 2024-04-26 on ClinicalTrials.gov
What's tested:Whole grain rye breadRefined grain rye bread

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Gastrointestinal Pressure (mmHg)
Measured over 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)
+9 more outcomes measured
Nutritional and Metabolic Diseases
Gastrointestinal Dysfunction
Cardiovascular Diseases
Dysbiosis
1 sites across 1 states
Illinois1

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Eligibility criteria

Inclusion

Healthy men and women

Exclusion

Diabetes Mellitus
Nutrient-malabsorption disorders
Intestinal Bowel Syndrome (IBS)
Intestinal Bowel Disease (IBD)
Bleeding-related disorders
Grain allergy
Psychological Disorders
Stenosis
Dysphasia
Bariatric Surgery
Gallbladder removal
Eating disorders
Antibiotic administration (within the past three months)
Hormone therapy
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
  • 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 GlucoseBaseline 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

  • TriglyceridesBaseline 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 CholesterolBaseline 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

  • HDL cholesterolBaseline 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 cholesterolBaseline 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

  • Lipopolysaccharide Binding ProteinBaseline 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