Microbiome Composition Changes on 4 Week Gluten-free Diet Challenge

April 8, 2016 updated by: Alexandra Zhernakova, University Medical Center Groningen

The Influence of a Short-term Gluten-free Diet on the Human Gut Microbiome

Changes in the gut microbiomes of healthy volunteers who followed a gluten-free diet (GFD) for four weeks were studied. Per participant, nine stool samples were collected: one at baseline, four during the GFD period, and four when they returned to their habitual diet. Microbiome profiles were determined using 16S rRNA sequencing and the samples were next processed for taxonomic and imputed functional composition. Additionally, participants kept a 3-day food diary and six gut health-related biomarkers were measured.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700 RB
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy participants aged >=16

Exclusion Criteria:

  • Known gastrointestinal disorder
  • Known food intolerance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: GFD
After instruction of a dietician, participants adhered to a gluten-free diet for 4 weeks.
Other: Dietary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in gut microbiota composition upon gluten-free diet intervention
Time Frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
baseline, 4 weeks gluten-free diet and 4 weeks habitual diet

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in gut associated biomarker levels: fecal calprotectin
Time Frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma cytokines: IL-1beta
Time Frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal human beta defensin 2
Time Frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal chromogranin A
Time Frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal short chain fatty acids: propionate
Time Frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma citrulline
Time Frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal short chain fatty acids: acetate
Time Frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal short chain fatty acids: butyrate
Time Frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal short chain fatty acids: valerate
Time Frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal short chain fatty acids: caproate
Time Frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma cytokines: IL-6
Time Frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma cytokines: IL-8
Time Frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma cytokines: IL-10
Time Frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma cytokines: IL-12
Time Frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma cytokines: TNFalpha
Time Frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
baseline, 4 weeks gluten-free diet and 4 weeks habitual diet

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

April 4, 2016

First Submitted That Met QC Criteria

April 4, 2016

First Posted (ESTIMATE)

April 8, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

April 11, 2016

Last Update Submitted That Met QC Criteria

April 8, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M12.113965

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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