Assessing Gut Microbiota Mediated Health Outcomes of Whole Wheat and Its Major Bioactive Components (NCT05318183) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Assessing Gut Microbiota Mediated Health Outcomes of Whole Wheat and Its Major Bioactive Components
United States65 participantsStarted 2022-01-27
Plain-language 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 order in which they will consume either whole wheat bread (4 servings) or white bread a day for two weeks prior to collecting specimens (stool, urine, and plasma/serum).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasma Glucose
Timeframe: Day 14 (0, 30, 60, 90, 120, 150, 180 minutes post oral glucose tolerance test)