Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06386471
Other study ID # 24093
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 7, 2024
Est. completion date June 2, 2025

Study information

Verified date April 2024
Source University of Illinois at Urbana-Champaign
Contact Brett R Loman, PhD, RD
Phone 217-333-3451
Email bloman2@illinois.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date June 2, 2025
Est. primary completion date June 12, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 63 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Whole grain rye bread
Single consumption of 4.3 oz of whole grain rye bread
Refined grain rye bread
Single consumption of 4.3 oz of refined grain rye bread

Locations

Country Name City State
United States University of Illinois at Urbana-Champaign Urbana Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gastrointestinal Pressure (mmHg) Pressure of gastrointestinal contractions as captured by the Medtronic Smartpill capsule temperature, transit time) 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)
Primary Luminal pH (pH units) pH of gastrointestinal contents as captured by the Medtronic Smartpill capsule 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)
Primary Temperature (degrees celcius) Temperature in the intestinal lumen as captured by the Medtronic Smartpill capsule 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)
Primary Gastrointestinal Transit Time (hours:minutes) Duration of gastrointestinal transit as captured by the Medtronic Smartpill capsule 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)
Primary Blood Glucose Concentration of glucose in whole blood from finger prick as measured by the Konsung Portable Dry Biochemical Analyzer 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)
Primary Triglycerides Concentration of triglycerides in whole blood from finger prick as measured by the Konsung Portable Dry Biochemical Analyzer 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)
Primary Total Cholesterol Concentration of total cholesterol in whole blood from finger prick as measured by the Konsung Portable Dry Biochemical Analyzer 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)
Primary HDL cholesterol Concentration of HDL cholesterol in whole blood from finger prick as measured by the Konsung Portable Dry Biochemical Analyzer 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)
Primary LDL cholesterol Concentration of LDL choelsterol in whole blood from finger prick as measured by the Konsung Portable Dry Biochemical Analyzer 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)
Primary Lipopolysaccharide Binding Protein Concentration of LBP in whole blood from finger prick as measured by ELISA 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 Microbiome Shotgun metagenomic sequencing of fecal samples, including metrics of diversity (ex: shannon index), taxonomic abundances (relative abundance, %), functional gene abundances (relative abundance, %), etc Fecal sample following ingestion of the Smartpill and test meal (approximately 24 hours into the study arm)
Secondary Metabolomics Untargeted metabolomics of fecal samples via LC-MS, including metrics of pathway analysis (pathway score), single metabolite relative concentration (relative intensity), etc Fecal sample following ingestion of the Smartpill and test meal (approximately 24 hours into the study arm)
See also
  Status Clinical Trial Phase
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT04056208 - Pistachios Blood Sugar Control, Heart and Gut Health Phase 2
Recruiting NCT04417387 - The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
Not yet recruiting NCT06211361 - Cardiac Rehabilitation Program in Patients With Cardiovascular Disease N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT04514445 - The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
Enrolling by invitation NCT04253054 - Chinese Multi-provincial Cohort Study-Beijing Project
Completed NCT03273972 - INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers N/A
Completed NCT03680638 - The Effect of Antioxidants on Skin Blood Flow During Local Heating Phase 1
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Completed NCT04083846 - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed) Phase 1
Completed NCT04083872 - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting) Phase 1
Completed NCT03693365 - Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
Completed NCT03619148 - The Incidence of Respiratory Symptoms Associated With the Use of HFNO N/A
Completed NCT03466333 - Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia Phase 2
Completed NCT04082585 - Total Health Improvement Program Research Project
Completed NCT05132998 - Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)