NCT01719913

The Effect of Gluten on Gut Microbiome and Metabolic Health.

Gut, Grain and Greens (3G): The Effect of Gluten on Gut Microbiome and Metabolic Health.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Objective: To identify how specific changes of the gluten content in the diet affect the host-gut microbiome interactions with implications for metabolic health. Design: A randomized, controlled, single-blinded, cross-over intervention trial consisting of two 8-week interventions periods, separated by a 6-week wash-out period. A total number of 60 participants will be included. Intervention: low vs high gluten intake.

Detailed description

The study is designed as a randomized, controlled, single-blinded, cross-over intervention trial consisting of two 8-week interventions periods, separated by a 6-week wash-out period. A total number of 60 participants will be included. Participants consume, in randomized order, a gluten-poor diet (\<5 g/d) in the active treatment period and a gluten-rich diet (\>25 g/d) during the control period. Measurements: Altered quantitative metagenomics at bacterial gene- and species levels is the primary outcome of this study. Secondary outcomes include metabolic and inflammatory markers, circulating appetite hormone levels,serum metabolomics, gastrointestinal transit time and intestinal permeability. Furthermore, selected control measures are included; 4-day food records and a study intervention dietary records.

Conditions

• Metabolic Diseases
• Injury of Gastrointestinal Tract

Interventions

Type	Name	Description
OTHER	High gluten	Refined grain/ gluten rich diet : Participants consume more than 25g of gluten per day (estimated to correspond to a gluten intake around the 90th percentile in the population)
OTHER	Low gluten	Poor gluten diet: Participants consume less than 5g gluten per day (estimated to correspond to a gluten intake below the 10th percentile in the population)

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-11-01
• Last updated: 2013-12-05

Locations

1 site across 1 country: Denmark