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

November 8, 2025 updated by: Richard Bruno, Ohio State University
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 these studies with regard to glucose homeostasis, with some persons being unaffected and others experiencing glucose-lowering effects due to whole wheat bread consumption. Whole grain (whole wheat) contains bioactive phytochemicals in addition to its well-recognized fiber content, and these constituents have not received adequate study to inform dietary recommendations. The objective of this study is to investigate the glucose-lowering effects of whole wheat bread in persons with prediabetes using multi-omics platforms that can provide an understanding of the complex interactions among the gut microbiome, gut metabolome, host metabolome, and gut barrier function. The hypothesis is that gut microbial metabolism of whole wheat and its major bioactive components is a determining factor of human health benefits. This will be tested by conducting a randomized, controlled crossover trial in persons with pre-diabetes who follow a controlled diet containing whole wheat bread or white bread for 2-weeks. Outcomes are expected to significantly advance an understanding of personalized, gut microbiome-mediated approaches in individuals with pre-diabetes to help guide dietary recommendations of whole wheat intake. In addition, novel evidence that maps out the differential functions of diverse genus/species of microbiota to biotransform whole wheat nutrients into more bioactive metabolites are expected.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Whole Wheat Bread
Participants consuming 128 g of whole wheat bread (4 slices of bread) daily for two weeks
Other: Whole Wheat Bread
Standardized whole wheat bread (128 g daily)
Placebo Comparator: White Bread (control)
Participants consuming 128 g of white bread (4 slices of bread) daily for two weeks
Other: White Bread (control)
Standardized white bread (128 g daily)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plasma Glucose
Time Frame: Day 14 (0, 30, 60, 90, 120, 150, 180 minutes post oral glucose tolerance test)
Data are biomarker area under the time-concentration curve (0-3 hours) on day 14
Day 14 (0, 30, 60, 90, 120, 150, 180 minutes post oral glucose tolerance test)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma Insulin
Time Frame: Day 14
Data are biomarker fasting concentrations
Day 14
Plasma Glucose
Time Frame: Day 14
Data are biomarker fasting concentrations.
Day 14
Serum C-reactive Protein
Time Frame: Day 14
Data are the biomarker serum concentration of C-reactive protein.
Day 14
Serum Tumor Necrosis Factor Alpha
Time Frame: Day 14
Data are biomarker serum tumor necrosis factor alpha concentrations.
Day 14
Serum Interleukin-6
Time Frame: Day 14
Data are biomarker serum interleukin-6 concentrations.
Day 14
Fecal Calprotectin
Time Frame: Day 14
Data are biomarker fecal concentrations.
Day 14
Fecal Myeloperoxidase
Time Frame: Day 14
Data are biomarker fecal concentrations.
Day 14
Urine Lactulose/Mannitol
Time Frame: Day 14
Data are the 24-hour urinary excretion ratio of lactulose relative to mannitol collected 0-5 h following the digestion of non-digestible sugar probes.
Day 14
Urine Sucralose/Erythritol
Time Frame: Day 14
Data are the sucralose/erythritol ratio measured in urine collected 6-24 h following the digestion of non-digestible sugar probes.
Day 14
Serum Endotoxin
Time Frame: Day 14
Data are biomarker fasting concentrations.
Day 14
Serum Myeloperoxidase
Time Frame: Day 14
Data are biomarker serum concentrations.
Day 14
Level of Toll-like Receptor 4 Gene Expression
Time Frame: Day 14
Data are expression of toll-like receptor 4 gene from peripheral blood mononuclear cells.
Day 14
Myeloid Differentiation Factor 88 Gene Expression
Time Frame: Day 14
Expression of myeloid differentiation factor 88 gene from peripheral blood mononuclear cells.
Day 14
Tumor Necrosis Factor Alpha Gene Expression
Time Frame: Day 14
Expression of tumor necrosis factor alpha gene from peripheral blood mononuclear cells.
Day 14
p65 Subunit of Nuclear Factor Kappa B Gene Expression
Time Frame: Day 14
Expression of p65 subunit of nuclear factor kappa B gene from peripheral blood mononuclear cells.
Day 14
Interleukin-6 Gene Expression
Time Frame: Day 14
Expression of interleukin-6 gene from peripheral blood mononuclear cells.
Day 14
Interleukin-8 Gene Expression
Time Frame: Day 14
Expression of interleukin-8 gene from peripheral blood mononuclear cells.
Day 14
Myeloperoxidase Gene Expression
Time Frame: Day 14
Expression of myeloperoxidase gene from peripheral blood mononuclear cells.
Day 14
Monocyte Chemoattractant Protein-1 Gene Expression
Time Frame: Day 14
Expression of monocyte chemoattractant protein-1 gene from peripheral blood mononuclear cells.
Day 14
Fecal Butyrate
Time Frame: Day 14
Data are biomarker fecal concentrations.
Day 14
Fecal Acetate
Time Frame: Day 14
Data are biomarker fecal concentrations.
Day 14
Fecal Propionate
Time Frame: Day 14
Data are biomarker fecal concentrations.
Day 14
Fecal Isobutyric Acid
Time Frame: Day 14
Data are biomarker fecal concentrations.
Day 14
Fecal Isovaleric Acid
Time Frame: Day 14
Data are biomarker fecal concentrations of isovaleric acid.
Day 14
Serum Alkylersorcinols
Time Frame: Day 14
Data are biomarker serum concentrations of alkylresorcinol and alkylresorcinol derivatives.
Day 14
Serum Benoxazinods
Time Frame: Day 14
Data are biomarker serum concentrations of benoxazinoids and benoxazinoids derivatives.
Day 14
Serum Phenolic Compounds
Time Frame: Day 14
Data are biomarker serum concentrations of phenolic compounds and phenolic derivatives.
Day 14
Fecal Alkylresorcinols
Time Frame: Day 14
Data are biomarker fecal concentrations of alkylresorcinols and alkylresorcinol derivatives.
Day 14
Fecal Benoxazinoids
Time Frame: Day 14
Data are biomarker fecal concentrations of benoxazinoids and benoxazinoids derivatives.
Day 14
Fecal Phenolic Compounds
Time Frame: Day 14
Data are fecal concentrations of phenolic compounds and phenolic derivatives.
Day 14

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma Triglyceride
Time Frame: Day 0, Day 14
Data are biomarker fasting plasma concentrations.
Day 0, Day 14
Plasma Cholesterol Levels
Time Frame: Day 14
Data are biomarker fasting plasma concentrations.
Day 14
Plasma HDL-cholesterol
Time Frame: Day 14
Data are biomarker fasting plasma concentrations.
Day 14
Serum Alanine Transaminase
Time Frame: Day 14
Data are biomarker serum concentrations of alanine transaminase.
Day 14
Serum Interleukin-8
Time Frame: Day 14
Data are biomarker serum interleukin-8 concentrations.
Day 14
Gut Microbiota Alpha-diversity Indices
Time Frame: Day 14
Alpha-diversity will be determined based on the Shannon-Wiener diversity index. Fecal microbiota assessments and the subsequent determinations of alpha-diversity.
Day 14
Gut Microbiota Beta-diversity Indices
Time Frame: Day 14
Beta-diversity will be determined based on the Bray-Curtis diversity index. Fecal microbiota assessments and the subsequent determinations of beta-diversity.
Day 14
Gut Microbiota Relative Abundance
Time Frame: Day 14
Gut microbiota relative abundance (percent order, genus, and species level) will be measured in fecal samples.
Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Department of Agriculture (USDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard Bruno, PhD, RD, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 27, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021H0347

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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