Microbiome Composition Changes on 4 Week Gluten-free Diet Challenge
Not Applicable
Completed
- Conditions
- Human Microbiome
- Interventions
- Other: Dietary intervention
- Registration Number
- NCT02731976
- Lead Sponsor
- University Medical Center Groningen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
- healthy participants aged >=16
Exclusion Criteria
- Known gastrointestinal disorder
- Known food intolerance
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GFD Dietary intervention After instruction of a dietician, participants adhered to a gluten-free diet for 4 weeks.
- Primary Outcome Measures
Name Time Method Changes in gut microbiota composition upon gluten-free diet intervention baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
- Secondary Outcome Measures
Name Time Method 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: fecal chromogranin A 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: TNFalpha 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 short chain fatty acids: propionate 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: plasma cytokines: IL-8 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: IL-1beta 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: 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
Trial Locations
- Locations (1)
University Medical Center Groningen
🇳🇱Groningen, Netherlands