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

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-27

Study Completion Date

2026-05-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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PreDiabetes Dysbiosis Endotoxemia Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Whole Wheat Bread

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

Group Type EXPERIMENTAL

Whole Wheat Bread

Intervention Type OTHER

Standardized whole wheat bread (128 g daily)

White Bread (control)

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

Group Type PLACEBO_COMPARATOR

White Bread (control)

Intervention Type OTHER

Standardized white bread (128 g daily)

Interventions

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Whole Wheat Bread

Standardized whole wheat bread (128 g daily)

Intervention Type OTHER

White Bread (control)

Standardized white bread (128 g daily)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No