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

The Ohio State University

Status: Active, not recruiting

Conditions: Dysbiosis; Inflammation; Endotoxemia; PreDiabetes

Treatments: Other: Whole Wheat Bread; Other: White Bread (control)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05318183

2021H0347

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

Whole Wheat Bread

Experimental group

Description:

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

Treatment:

Other: Whole Wheat Bread

White Bread (control)

Placebo Comparator group

Description:

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

Treatment:

Other: White Bread (control)