Microbiome Composition Changes on 4 Week Gluten-free Diet Challenge

Sponsor

University Medical Center Groningen (Other)

Overall Status

Completed

CT.gov ID

NCT02731976

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Human Microbiome	Other: Dietary intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: GFD

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

Other: Dietary intervention

Outcome Measures

Primary Outcome Measures

Changes in gut microbiota composition upon gluten-free diet intervention [baseline, 4 weeks gluten-free diet and 4 weeks habitual diet]

Secondary Outcome Measures

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]
Changes in gut associated biomarker levels: plasma citrulline [baseline, 4 weeks gluten-free diet and 4 weeks habitual diet]
Changes in gut associated biomarker levels: fecal short chain fatty acids: acetate [baseline, 4 weeks gluten-free diet and 4 weeks habitual diet]
Changes in gut associated biomarker levels: fecal short chain fatty acids: butyrate [baseline, 4 weeks gluten-free diet and 4 weeks habitual diet]
Changes in gut associated biomarker levels: fecal short chain fatty acids: valerate [baseline, 4 weeks gluten-free diet and 4 weeks habitual diet]
Changes in gut associated biomarker levels: fecal short chain fatty acids: caproate [baseline, 4 weeks gluten-free diet and 4 weeks habitual diet]
Changes in gut associated biomarker levels: plasma cytokines: IL-6 [baseline, 4 weeks gluten-free diet and 4 weeks habitual diet]
Changes in gut associated biomarker levels: plasma cytokines: IL-8 [baseline, 4 weeks gluten-free diet and 4 weeks habitual diet]
Changes in gut associated biomarker levels: plasma cytokines: IL-10 [baseline, 4 weeks gluten-free diet and 4 weeks habitual diet]
Changes in gut associated biomarker levels: plasma cytokines: IL-12 [baseline, 4 weeks gluten-free diet and 4 weeks habitual diet]
Changes in gut associated biomarker levels: plasma cytokines: TNFalpha [baseline, 4 weeks gluten-free diet and 4 weeks habitual diet]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

healthy participants aged >=16

Exclusion Criteria:

Known gastrointestinal disorder
Known food intolerance

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Groningen	Groningen		Netherlands	9700 RB

Sponsors and Collaborators

University Medical Center Groningen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alexandra Zhernakova, Dr, University Medical Center Groningen

ClinicalTrials.gov Identifier:

NCT02731976

Other Study ID Numbers:

M12.113965

First Posted:

Apr 8, 2016

Last Update Posted:

Apr 11, 2016

Last Verified:

Apr 1, 2016

Keywords provided by Alexandra Zhernakova, Dr, University Medical Center Groningen

Gluten-Free diet

Healthy individuals

Study Results

No Results Posted as of Apr 11, 2016