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

NCT05318183 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-11-20

Study results available
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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).

Conditions

Interventions

OTHER

Whole Wheat Bread

Standardized whole wheat bread (128 g daily)

OTHER

White Bread (control)

Standardized white bread (128 g daily)

Sponsors & Collaborators

  • United States Department of Agriculture (USDA)

    collaborator FED

  • Ohio State University

    lead OTHER

Principal Investigators

  • Richard Bruno, PhD, RD · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-27
Primary Completion
2024-05-30
Completion
2026-05-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05318183 on ClinicalTrials.gov