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Food Effects on the Gut Microbiota

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ClinicalTrials.gov Identifier: NCT03078283
Recruitment Status : Active, not recruiting
First Posted : March 13, 2017
Last Update Posted : March 29, 2019
Sponsor:
Collaborator:
Mondelēz International, Inc.
Information provided by (Responsible Party):
Jeffrey I. Gordon, Washington University School of Medicine

Brief Summary:
This is a small-scale study of the effects on microbes in the human gut of adding high-fiber snack foods to usual diet. The snack foods are being provided by Mondelez International, Inc. Eight pairs of dizygotic twins, discordant or concordant for obesity, will participate in the study. They will complete 3 successive experiments in which their regular diet is supplemented by consumption, over a 6-week period, of high-fiber snack foods. Each experiment will involve (i) two weeks consuming regular diet (fecal sample collected weekly); (ii) one week consuming one snack food per day (approximately 7 g fiber, collection of all fecal samples), (iii) one week consuming two snack foods per day (approximately 14 g fiber, collection of all fecal samples), (iv) four weeks consuming three snack foods per day (approximately 20 g fiber, collection of all fecal samples); and (v) two weeks consuming only regular diet (weekly collection of fecal sample). For each experiment, participants will also provide a fasting blood sample during the free diet phase at the end of the week just before initiation of snack consumption, and a fasting blood sample at the end of the last week of snack consumption. Participants will also collect one first morning urine sample weekly throughout the study. During week 2, participants will also collect first morning urine samples for 3 consecutive days. Similarly, they will collect first morning urine samples for the last 3 consecutive days of the last week of snack consumption. The study will test the effects of the different fiber-rich snacks on the composition and metabolic properties of the gut microbial community in lean and obese subjects.

Condition or disease Intervention/treatment Phase
Gut Microbial Responses to Dietary Fiber Other: high-fiber food type Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of High-fiber Snack Foods on Human Gut Microbes
Actual Study Start Date : April 10, 2017
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
Experimental: Participants
Consumption of a given type of high-fiber snack food, with each individual functioning as her own control
Other: high-fiber food type
In 3 successive experiments, usual diet will be supplemented with snack foods containing fiber of plant, fruit or grain origin.




Primary Outcome Measures :
  1. Assessment of gut microbial community structure and function [ Time Frame: 8 weeks ]
    Sequencing bacterial 16S rRNA amplicons plus shotgun sequencing of fecal community DNA to identify effects of fiber-enriched foods on bacterial community and gene representation; mass spectrometry of products of gut microbial community metabolism.



Information from the National Library of Medicine

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Ages Eligible for Study:   31 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

* member of female dizygotic twin pair discordant or concordant for obesity

Exclusion Criteria:

  • pregnant or trying to get pregnant
  • inflammatory bowel disease
  • gastrointestinal cancer
  • hepatitis
  • HIV
  • renal failure
  • food allergies

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 ClinicalTrials.gov identifier (NCT number): NCT03078283


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Mondelēz International, Inc.
Investigators
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Principal Investigator: Jeffrey I Gordon, MD Washington University School of Medicine

Publications:
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Responsible Party: Jeffrey I. Gordon, Dr. Robert J. Glaser Distinguished University Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03078283     History of Changes
Other Study ID Numbers: MDLZ2017JIG1
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual data will be shared after completion of the study, to the extent that this can be accomplished without violating the confidentiality of participants (some of whom would be easily identifiable from their clinical metadata).

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