Whole Grain and Fiber Addition Study

Study Overview
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Brief Summary
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The human gut microbiota is the complex community of bacteria that reside within the human gastrointestinal tract. This community plays an important role in supporting normal immune function and digestion. Disruption of the microbial communities within the gastrointestinal tract, sometimes termed dysbiosis is linked to a wide range of human diseases, including obesity, metabolic syndrome, malnutrition, and cancer. Stability of the microbiome is thought to be important for human health, however the factors that drive microbiome community stability are poorly understood. Within the gastrointestinal tract, the microbiota is constantly exposed to complex mixtures of foods and the products of digestion. Importantly, changes in diet have been shown to rapidly induce shifts in microbial community composition. These compositional shifts can also affect microbial production of bioactive metabolites, which may be one mechanism to explain how the microbiome impacts host physiology and disease. Fiber is often considered to be one of the largest contributors to microbial compositional shifts that follow dietary interventions. Fiber resists digestion and persists through the gastrointestinal tract to reach the large intestine where it can be metabolized by bacteria. The end products of this metabolism are the short chain fatty acids (SCFAs), acetate and butyrate, which are often associated with beneficial health outcomes. Fibrous foods are also a source of polyphenols and other phenolic compounds that may be used by microbes in the production of secondary metabolites or freed from the food matrix by microbial enzymes. The purpose of this study is to: 1) to investigate the impact of high fiber, whole grain and bran cereal on microbiome stability, and 2) to explore the microbial contribution to polyphenol metabolism from whole grain in healthy individuals.

Official Title
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Microbiome Stability After Addition of a High Fiber, Whole Grain and Bran Cereal to the Diets of Healthy Individuals

Conditions
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Healthy

Intervention / Treatment
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* Other: Fiber cereal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults over 18 years BMI between 18 and 30 English speaker with ability to use a computer/smartphone. Exclusion Criteria: Women who are currently pregnant or breastfeeding Current use of antibiotics or use of antibiotics within the last month Self-reported, pre-existing history of gastrointestinal disease including IBD, IBS, Crohn's disease, Celiac disease (or self-reported sensitivity to gluten), history of bowel blockage/impacted stool, fecal incontinence, gastroparesis or diverticulosis. Type I/II diabetes mellitus Participants actively trying to lose weight Chronic use of antacids and/or laxatives Use of seizure disorder medications or tricyclic antidepressants Consumption of drugs or supplements related to energy intake (i.e. diet pills and appetite suppressants)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fiber Intervention I<br>Participants will be asked to consume two ½ cup servings of fiber cereal daily (equivalent to 28 g fiber) for 14 days, one in the morning and one in the evening. | Other: Fiber cereal<br>* Whole grain and bran cereal<br>|
| Experimental: Fiber Intervention II<br>Participants will be asked to consume two ¼ cup servings of fiber cereal daily (equivalent to 14 g fiber) for 14 days, one in the morning and one in the evening. | Other: Fiber cereal<br>* Whole grain and bran cereal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in microbiome stability | Shotgun metagenomic sequencing of stool samples | Change from baseline to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiome functional capacity | Assessment of microbiome functional capacity using DNA alignment to KEGG orthology | Baseline, 2 weeks, 6 weeks | 
| Urinary metabolome | Targeted liquid chromatography mass spectroscopy to detect urinary metabolites | Baseline, 2 weeks, 6 weeks | 
| Fecal short chain fatty acids | Targeted liquid chromatography mass spectroscopy | Baseline, 2 weeks, 6 weeks |