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

NCT05318183 | Active Not Recruiting Results

• 1 other identifier: 2021H0347
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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 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

PreDiabetes; Dysbiosis; Endotoxemia; Inflammation

Keywords

Gut microbiota; Microbiome; Metabolomics; Prediabetes; Glycemic response; Intestinal permeability; Gut dysbiosis; Microbiome metabolism; Whole Wheat; Phytochemicals

Outcome Measures

Primary Outcomes (1)

• Plasma Glucose

  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 Outcomes (30)

• Plasma Insulin

  Day 14

• Plasma Glucose

  Day 14

• Serum C-reactive Protein

  Day 14

• Serum Tumor Necrosis Factor Alpha

  Day 14

• Serum Interleukin-6

  Day 14

Other Outcomes (8)

• Plasma Triglyceride

  Day 0, Day 14

• Plasma Cholesterol Levels

  Day 14

• Plasma HDL-cholesterol

  Day 14

Study Arms (2)

Whole Wheat Bread

EXPERIMENTAL

Participants consuming 128 g of whole wheat bread (4 slices of bread) daily for two weeks

Other: Whole Wheat Bread

White Bread (control)

PLACEBO COMPARATOR

Participants consuming 128 g of white bread (4 slices of bread) daily for two weeks

Other: White Bread (control)

Interventions

Whole Wheat Bread OTHER

Standardized whole wheat bread (128 g daily)

Whole Wheat Bread

White Bread (control) OTHER

Standardized white bread (128 g daily)

White Bread (control)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fasting blood glucose between 100-125 mg/dL
• BMI of 30-35 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Cao S, Pierson JT, Bond AH, Zhang S, Gold A, Zhang H, Zamary KM, Moats P, Teegarden MD, Peterson DG, Mo X, Zhu J, Bruno RS. Intestinal-level anti-inflammatory bioactivities of whole wheat: Rationale, design, and methods of a randomized, controlled, crossover dietary trial in adults with prediabetes. Nutr Res. 2024 Nov;131:83-95. doi: 10.1016/j.nutres.2024.09.010. Epub 2024 Sep 18.

  PMID: 39378659 BACKGROUND

MeSH Terms

Conditions

Prediabetic State; Dysbiosis; Endotoxemia; Inflammation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacteremia; Sepsis; Infections; Toxemia; Systemic Inflammatory Response Syndrome

Results Point of Contact

• Title: Richard Bruno
• Organization: The Ohio State University

bruno.27@osu.edu

614.292.5522

Study Officials

• Richard Bruno, PhD, RD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized to receive 4 servings per day of whole wheat bread (WWB) or white bread (WB) for 2 weeks. During each study arm, participants will be provided eucaloric standardized diets that are devoid of whole wheat products, probiotic-containing foods, and fermented foods. Before and after each study arm, a fasting blood sample and fecal sample will be obtained for metabolomic and clinical measures. Anthropometric measurements and blood pressure will be assessed at days 0, 7, and 14 of each study arm. On day 14, participants will complete an oral glucose tolerance test (OGTT) with collection of blood samples every 30 minutes for 3 hours and a simultaneous gut permeability test that entails ingesting non-digestible sugar probes and subsequent 24-h collection of urine. Upon completion of these procedures, participants will undergo a \~1 month washout before repeating the study identically, with the crossover to the alternate bread diet.

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 8, 2022
• Study Start: January 27, 2022
• Primary Completion: May 30, 2024
• Study Completion (Estimated): May 30, 2026
• Last Updated: November 20, 2025
• Results First Posted: August 29, 2025

Record last verified: 2025-11

Locations

US (1)