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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Columbus, Ohio, United States
Columbus, Ohio, United States
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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