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Whole Grain and Fiber Addition Study

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ClinicalTrials.gov Identifier: NCT03623308
Recruitment Status : Completed
First Posted : August 9, 2018
Last Update Posted : November 1, 2019
Sponsor:
Collaborator:
General Mills Inc.
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE April 12, 2018
First Posted Date  ICMJE August 9, 2018
Last Update Posted Date November 1, 2019
Actual Study Start Date  ICMJE May 4, 2018
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
Change in microbiome stability [ Time Frame: Change from baseline to 6 weeks ]
Shotgun metagenomic sequencing of stool samples
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03623308 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
  • Microbiome functional capacity [ Time Frame: Baseline, 2 weeks, 6 weeks ]
    Assessment of microbiome functional capacity using DNA alignment to KEGG orthology
  • Urinary metabolome [ Time Frame: Baseline, 2 weeks, 6 weeks ]
    Targeted liquid chromatography mass spectroscopy to detect urinary metabolites
  • Fecal short chain fatty acids [ Time Frame: Baseline, 2 weeks, 6 weeks ]
    Targeted liquid chromatography mass spectroscopy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Whole Grain and Fiber Addition Study
Official Title  ICMJE Microbiome Stability After Addition of a High Fiber, Whole Grain and Bran Cereal to the Diets of Healthy Individuals
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Other: Fiber cereal
Whole grain and bran cereal
Study Arms  ICMJE
  • 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.
    Intervention: Other: Fiber 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.
    Intervention: Other: Fiber cereal
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2019)
29
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2018)
50
Actual Study Completion Date  ICMJE March 1, 2019
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03623308
Other Study ID Numbers  ICMJE STUDY00002230
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE General Mills Inc.
Investigators  ICMJE Not Provided
PRS Account University of Minnesota
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP