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Microbiome Composition Changes on 4 Week Gluten-free Diet Challenge

NCT ID: NCT02731976

Last Updated: 2024-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Human Microbiome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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GFD

After instruction of a dietician, participants adhered to a gluten-free diet for 4 weeks.

Group Type EXPERIMENTAL

Dietary intervention

Intervention Type OTHER

Interventions

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Dietary intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy participants aged \>=16

Exclusion Criteria

* Known gastrointestinal disorder
* Known food intolerance
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Medical Center Groningen

Groningen, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type RESULT
PMID: 23774130 (View on PubMed)

Other Identifiers

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M12.113965

Identifier Type: -

Identifier Source: org_study_id

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