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Whole Grain and Fiber Addition Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03623308
Enrollment
29
Registered
2018-08-09
Start date
2018-05-04
Completion date
2019-03-01
Last updated
2019-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

OTHERFiber cereal

Whole grain and bran cereal

Sponsors

General Mills
CollaboratorINDUSTRY
University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in microbiome stabilityChange from baseline to 6 weeksShotgun metagenomic sequencing of stool samples

Secondary

MeasureTime frameDescription
Microbiome functional capacityBaseline, 2 weeks, 6 weeksAssessment of microbiome functional capacity using DNA alignment to KEGG orthology
Urinary metabolomeBaseline, 2 weeks, 6 weeksTargeted liquid chromatography mass spectroscopy to detect urinary metabolites
Fecal short chain fatty acidsBaseline, 2 weeks, 6 weeksTargeted liquid chromatography mass spectroscopy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026