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Whole Grain and Fiber Addition Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03623308
Recruitment Status : Completed
First Posted : August 9, 2018
Last Update Posted : November 1, 2019
General Mills Inc.
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Healthy Other: Fiber cereal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Microbiome Stability After Addition of a High Fiber, Whole Grain and Bran Cereal to the Diets of Healthy Individuals
Actual Study Start Date : May 4, 2018
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
Experimental: Fiber Intervention I
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
Whole grain and bran cereal

Experimental: Fiber Intervention II
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
Whole grain and bran cereal

Primary Outcome Measures :
  1. Change in microbiome stability [ Time Frame: Change from baseline to 6 weeks ]
    Shotgun metagenomic sequencing of stool samples

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03623308

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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
General Mills Inc.

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Responsible Party: University of Minnesota Identifier: NCT03623308     History of Changes
Other Study ID Numbers: STUDY00002230
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No