Metabolic Diseases Clinical Trial
Official title:
Gut, Grain and Greens (3G): The Effect of Gluten on Gut Microbiome and Metabolic Health.
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.
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.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
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