🏛️ Verified NIH Record • Updated 2025-11-08
Assessing Gut Microbiota Mediated Health Outcomes of Whole Wheat and Its Major Bioactive Components (NCT05318183)
🔵 Active, Not Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: Ohio State University
🩺 Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: The Ohio State University — Columbus, Ohio
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
- Whole Wheat Bread (OTHER)
- White Bread (control) (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- The Ohio State University — Columbus, Ohio
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.