Healthy Clinical Trial
Official title:
Microbiome Stability After Addition of a High Fiber, Whole Grain and Bran Cereal to the Diets of Healthy Individuals
NCT number | NCT03623308 |
Other study ID # | STUDY00002230 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 4, 2018 |
Est. completion date | March 1, 2019 |
Verified date | October 2019 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | March 1, 2019 |
Est. primary completion date | March 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota | General Mills Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in microbiome stability | Shotgun metagenomic sequencing of stool samples | Change from baseline to 6 weeks | |
Secondary | Microbiome functional capacity | Assessment of microbiome functional capacity using DNA alignment to KEGG orthology | Baseline, 2 weeks, 6 weeks | |
Secondary | Urinary metabolome | Targeted liquid chromatography mass spectroscopy to detect urinary metabolites | Baseline, 2 weeks, 6 weeks | |
Secondary | Fecal short chain fatty acids | Targeted liquid chromatography mass spectroscopy | Baseline, 2 weeks, 6 weeks |
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