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

N/AActive Not RecruitingNCT05318183

Ohio State University65 enrolled

Overview

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).

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Conditions

PreDiabetes Dysbiosis Endotoxemia Inflammation

Interventions

Whole Wheat BreadOTHER

Standardized whole wheat bread (128 g daily)

White Bread (control)OTHER

Standardized white bread (128 g daily)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

The Ohio State University

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Plasma Glucose

Data are biomarker area under the time-concentration curve (0-3 hours) on day 14

Time frame: Day 14 (0, 30, 60, 90, 120, 150, 180 minutes post oral glucose tolerance test)

Secondary Outcomes

Plasma Insulin

Data are biomarker fasting concentrations

Time frame: Day 14

Plasma Glucose

Data are biomarker fasting concentrations.

Time frame: Day 14

Serum C-reactive Protein

Data are the biomarker serum concentration of C-reactive protein.

Time frame: Day 14

Serum Tumor Necrosis Factor Alpha

Data are biomarker serum tumor necrosis factor alpha concentrations.

Time frame: Day 14

Serum Interleukin-6

Data are biomarker serum interleukin-6 concentrations.

Time frame: Day 14

Fecal Calprotectin

Data are biomarker fecal concentrations.

Time frame: Day 14

Fecal Myeloperoxidase

Data are biomarker fecal concentrations.

Time frame: Day 14

Urine Lactulose/Mannitol

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.

Data from ClinicalTrials.gov

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