Microbiome Composition Changes on 4 Week Gluten-free Diet Challenge
The Influence of a Short-term Gluten-free Diet on the Human Gut Microbiome
1 other identifier
interventional
21
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 4, 2016
CompletedFirst Posted
Study publicly available on registry
April 8, 2016
CompletedApril 18, 2024
April 1, 2024
3 months
April 4, 2016
April 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in gut microbiota composition upon gluten-free diet intervention
baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Secondary Outcomes (15)
Changes in gut associated biomarker levels: fecal calprotectin
baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: plasma cytokines: IL-1beta
baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal human beta defensin 2
baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal chromogranin A
baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Changes in gut associated biomarker levels: fecal short chain fatty acids: propionate
baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
- +10 more secondary outcomes
Study Arms (1)
GFD
EXPERIMENTALAfter instruction of a dietician, participants adhered to a gluten-free diet for 4 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- healthy participants aged \>=16
You may not qualify if:
- Known gastrointestinal disorder
- Known food intolerance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center Groningen
Groningen, 9700 RB, Netherlands
Related Publications (1)
Baranska A, Tigchelaar E, Smolinska A, Dallinga JW, Moonen EJ, Dekens JA, Wijmenga C, Zhernakova A, van Schooten FJ. Profile of volatile organic compounds in exhaled breath changes as a result of gluten-free diet. J Breath Res. 2013 Sep;7(3):037104. doi: 10.1088/1752-7155/7/3/037104. Epub 2013 Jun 18.
PMID: 23774130RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2016
First Posted
April 8, 2016
Study Start
November 1, 2011
Primary Completion
February 1, 2012
Study Completion
May 1, 2014
Last Updated
April 18, 2024
Record last verified: 2024-04