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Search / Trial NCT05318183

Assessing Gut Microbiota Mediated Health Outcomes of Whole Wheat and Its Major Bioactive Components

Launched by OHIO STATE UNIVERSITY · Mar 31, 2022

Trial Information

Current as of July 21, 2025

Active, not recruiting

Keywords

Gut Microbiota Microbiome Metabolomics Prediabetes Glycemic Response Intestinal Permeability Gut Dysbiosis Microbiome Metabolism Whole Wheat Phytochemicals

ClinConnect Summary

This clinical trial is studying how eating whole wheat may affect health, specifically focusing on adults who have pre-diabetes. The researchers want to see how whole wheat consumption influences the gut bacteria and overall health compared to white bread. Participants in the study will eat either four servings of whole wheat bread or white bread each day for two weeks. After this period, they will provide samples of their stool, urine, and blood for analysis.

To join the study, participants should be between 65 and 74 years old, have a fasting blood sugar level between 100-125 mg/dL, and a body mass index (BMI) between 30-35 kg/m². However, individuals with certain health conditions, such as diabetes, liver disease, or those taking specific medications, won't be eligible to participate. This study is currently active but not recruiting new participants. If you or someone you know might be interested, it's essential to consider these eligibility criteria before proceeding.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Fasting blood glucose between 100-125 mg/dL
  • BMI of 30-35 kg/m2
  • Exclusion Criteria:
  • History of liver disease, cardiovascular disease, overt diabetes, or cancer
  • Prescribed medications for hyperglycemia or dyslipidemia
  • Use of dietary supplements, prebiotics, or probiotics
  • Usage of antibiotics or anti-fungals within 3 months prior to enrollment
  • Smoker
  • Alcohol consumption greater than 2 drinks per day
  • Aerobic exercise greater than 5 hours per week
  • Pregnancy or fertility treatments
  • History of chronically active inflammatory or neoplastic disease in 3 years prior to enrollment
  • History of chronic gastrointestinal disorder including diarrhea, inflammatory bowel disease, celiac disease; coagulation disorders, chronic immunosuppressive medication usage
  • History of myocardial infarction or cerebrovascular accident within 6 months prior to participation

About Ohio State University

The Ohio State University (OSU) is a leading research institution dedicated to advancing health and science through innovative clinical trials. With a commitment to improving patient care and outcomes, OSU leverages its extensive resources, interdisciplinary collaboration, and expertise in diverse medical fields. The university fosters an environment of rigorous scientific inquiry, ensuring that clinical trials are conducted with the highest ethical standards and adherence to regulatory guidelines. Through its Clinical Trials Office, OSU aims to translate groundbreaking research into practical applications, benefiting both local and global communities.

Locations

Columbus, Ohio, United States

Columbus, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Richard Bruno, PhD, RD

Principal Investigator

Ohio State University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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