Status:
ACTIVE_NOT_RECRUITING
Assessing Gut Microbiota Mediated Health Outcomes of Whole Wheat and Its Major Bioactive Components
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
United States Department of Agriculture (USDA)
Conditions:
PreDiabetes
Dysbiosis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study will investigate the gut microbiota-mediated effects of whole wheat consumption on human health in adults with pre-diabetes. Participants will complete two phases of intervention in random ...
Detailed Description
Accumulating clinical evidence suggests positive effects of whole grain on cardiometabolic risk. However, outcomes of controlled trials indicate that substantial interpersonal variation occurs in thes...
Eligibility Criteria
Inclusion
- Fasting blood glucose between 100-125 mg/dL
- BMI of 30-35 kg/m2
Exclusion
- 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
Key Trial Info
Start Date :
January 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2026
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT05318183
Start Date
January 27 2022
End Date
May 30 2026
Last Update
November 20 2025
Active Locations (1)
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1
The Ohio State University
Columbus, Ohio, United States, 43210