NCT02731976 - Microbiome Composition Changes on 4 Week Gluten-free Diet Challenge | Crick | Crick

Microbiome Composition Changes on 4 Week Gluten-free Diet Challenge

N/ACompletedNCT02731976

University Medical Center Groningen21 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

21

Conditions

Human Microbiome

Interventions

Dietary interventionOTHER

Eligibility

Sex: ALLMin age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy participants aged \>=16 Exclusion Criteria: * Known gastrointestinal disorder * Known food intolerance

Locations (1)

University Medical Center Groningen

Groningen, Netherlands

Outcomes

Primary Outcomes

Changes in gut microbiota composition upon gluten-free diet intervention

Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet

Secondary Outcomes

Changes in gut associated biomarker levels: fecal calprotectin

Time frame: 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

Changes in gut associated biomarker levels: fecal human beta defensin 2

Time frame: 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

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

Changes in gut associated biomarker levels: plasma citrulline

Time frame: 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

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

Data from ClinicalTrials.gov

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