Clinical trial NCT02731976: Microbiome Composition Changes on 4 Week Gluten-free Diet Challenge
Official title: The Influence of a Short-term Gluten-free Diet on the Human Gut Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Microbiome
Keywords: Gluten-Free diet
Healthy individuals
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2016-04-08
Enrollment: 21
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* healthy participants aged \>=16

Exclusion Criteria:

* Known gastrointestinal disorder
* Known food intolerance

Primary outcomes:
measure: Changes in gut microbiota composition upon gluten-free diet intervention
timeFrame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Secondary outcomes:
measure: Changes in gut associated biomarker levels: fecal calprotectin
timeFrame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
measure: Changes in gut associated biomarker levels: plasma cytokines: IL-1beta
timeFrame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
measure: Changes in gut associated biomarker levels: fecal human beta defensin 2
timeFrame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
measure: Changes in gut associated biomarker levels: fecal chromogranin A
timeFrame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
measure: Changes in gut associated biomarker levels: fecal short chain fatty acids: propionate
timeFrame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
measure: Changes in gut associated biomarker levels: plasma citrulline
timeFrame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
measure: Changes in gut associated biomarker levels: fecal short chain fatty acids: acetate
timeFrame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
measure: Changes in gut associated biomarker levels: fecal short chain fatty acids: butyrate
timeFrame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
measure: Changes in gut associated biomarker levels: fecal short chain fatty acids: valerate
timeFrame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
measure: Changes in gut associated biomarker levels: fecal short chain fatty acids: caproate
timeFrame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
measure: Changes in gut associated biomarker levels: plasma cytokines: IL-6
timeFrame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
measure: Changes in gut associated biomarker levels: plasma cytokines: IL-8
timeFrame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
measure: Changes in gut associated biomarker levels: plasma cytokines: IL-10
timeFrame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
measure: Changes in gut associated biomarker levels: plasma cytokines: IL-12
timeFrame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
measure: Changes in gut associated biomarker levels: plasma cytokines: TNFalpha
timeFrame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
citation: 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.