Nutritional and Metabolic DiseasesNCT06386471
Personalized GI Motility Responses to Diet
A study testing Whole grain rye bread and Refined grain rye bread in people with Nutritional and Metabolic Diseases and Gastrointestinal Dysfunction, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 63 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional and Metabolic Diseases, Gastrointestinal Dysfunction, Cardiovascular Diseases
- What is being tested?
- Whole grain rye bread and Refined grain rye bread
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2024to 2 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 63 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
Who cannot join
- Physician-Diagnosed:
- Diabetes Mellitus
- Nutrient-malabsorption disorders
- Intestinal Bowel Syndrome (IBS)
- Intestinal Bowel Disease (IBD)
- Bleeding-related disorders
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
Brett R Loman, PhD, RD
Brett R Loman, PhD, RD
About this study
Official title: Personalized Gastrointestinal Motility Responses to Dietary Fiber and Gut Microbial Metabolites
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
- Being tested
- Whole grain rye bread, Refined grain rye bread
- Keywords
- dietary fiber, gastrointestinal motility, cardiometabolic, microbiome
- Medical subject headings
- Nutritional and Metabolic Diseases, Cardiovascular Diseases, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole grain rye breadOther
Single consumption of 4.3 oz of whole grain rye bread
Refined grain rye breadOther
Single consumption of 4.3 oz of refined grain rye bread
| Study group | Role | What they receive |
|---|---|---|
| Whole grain rye bread | Experimental | 4.3 ounces of whole grain rye bread, consumed after an overnight fast (12+ hours) Receives: Other: Whole grain rye bread |
| Refined grain rye bread | Placebo comparator | 4.3 ounces of white rye bread, consumed after an overnight fast (12+ hours) Receives: Other: Refined grain rye bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Pressure (mmHg)
Pressure of gastrointestinal contractions as captured by the Medtronic Smartpill capsule temperature, transit time)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Concentration of triglycerides in whole blood from finger prick as measured by the Konsung Portable Dry Biochemical Analyzer
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 (2)
Microbiome
Shotgun metagenomic sequencing of fecal samples, including metrics of diversity (ex: shannon index), taxonomic abundances (relative abundance, %), functional gene abundances (relative abundance, %), etc
Measured: Fecal sample following ingestion of the Smartpill and test meal (approximately 24 hours into the study arm)
Metabolomics
Untargeted metabolomics of fecal samples via LC-MS, including metrics of pathway analysis (pathway score), single metabolite relative concentration (relative intensity), etc
Measured: Fecal sample following ingestion of the Smartpill and test meal (approximately 24 hours into the study arm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start7 Mar 2024
- Primary completion12 Jun 2024 (estimated)
- Study completion2 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional and Metabolic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, controlled, crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386471
- Sponsor's protocol ID
- 24093
- Status last verified
- Apr 2024
- First submitted
- 4 Mar 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Gastrointestinal Motility Responses to Dietary Fiber and Gut Microbial Metabolites
- ClinicalTrials.gov ID
- NCT06386471
- Acronym / sponsor ID
- 24093
- Conditions
- Nutritional and Metabolic Diseases, Gastrointestinal Dysfunction, Cardiovascular Diseases, Dysbiosis
- Keywords
- dietary fiber, gastrointestinal motility, cardiometabolic, microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 12 Jun 2024 (estimated)
- Study completion
- 2 Jun 2025 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled, crossover
| Arm | Type | Receives |
|---|---|---|
| Whole grain rye bread | Experimental | Other: Whole grain rye bread4.3 ounces of whole grain rye bread, consumed after an overnight fast (12+ hours) |
| Refined grain rye bread | Placebo comparator | Other: Refined grain rye bread4.3 ounces of white rye bread, consumed after an overnight fast (12+ hours) |
Who may qualify
- Ages
- 21 to 63 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy men and women
Key exclusion criteria (26 listed)
- Diabetes Mellitus
- Nutrient-malabsorption disorders
- Intestinal Bowel Syndrome (IBS)
- Intestinal Bowel Disease (IBD)
- Bleeding-related disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole grain rye breadSingle consumption of 4.3 oz of whole grain rye bread | Other | Whole grain rye bread |
| Refined grain rye breadSingle consumption of 4.3 oz of refined grain rye bread | Other | Refined grain rye bread |
Primary outcome
Gastrointestinal Pressure (mmHg)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
HDL cholesterol
Time frame: 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
Time frame: 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
Lipopolysaccharide Binding Protein
Time frame: 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
2 secondary outcomes
Microbiome
Time frame: Fecal sample following ingestion of the Smartpill and test meal (approximately 24 hours into the study arm)
Metabolomics
Time frame: Fecal sample following ingestion of the Smartpill and test meal (approximately 24 hours into the study arm)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole grain rye bread and Refined grain rye bread in people with Nutritional and Metabolic Diseases and Gastrointestinal Dysfunction, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brett R Loman, PhD, RD (217-333-3451, bloman2@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal Pressure (mmHg) (time frame: 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)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.