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NCT Number: NCT03623308

Whole Grain and Fiber Addition Study

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fiber cereal

Other

Whole grain and bran cereal

Primary outcomes

  1. Change in microbiome stability

    Time frame: Change from baseline to 6 weeks

    Shotgun metagenomic sequencing of stool samples

Secondary outcomes

  1. Microbiome functional capacity

    Time frame: Baseline, 2 weeks, 6 weeks

    Assessment of microbiome functional capacity using DNA alignment to KEGG orthology

  2. Urinary metabolome

    Time frame: Baseline, 2 weeks, 6 weeks

    Targeted liquid chromatography mass spectroscopy to detect urinary metabolites

  3. Fecal short chain fatty acids

    Time frame: Baseline, 2 weeks, 6 weeks

    Targeted liquid chromatography mass spectroscopy

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • General Mills

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 9, 2018
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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