Journal of Clinical Trials

Journal of Clinical Trials
Open Access

ISSN: 2167-0870

+44 1478 350008


Two Randomized Cross-Over Trials Assessing the Impact of Dietary Gluten or Wholegrain on the Gut Microbiome and Host Metabolic Health

Sabine Ibrügger, Rikke Juul Gøbel, Henrik Vestergaard, Tine Rask Licht, Hanne Frøkiær, Allan Linneberg, Torben Hansen, Ramneek Gupta, Oluf Pedersen, Mette Kristensen and Lotte Lauritzen

Background: Gut microbiota composition and activity may be changed by dietary factors and possibly affect
metabolic health. Dietary gluten and wholegrain are suggested to influence metabolism in a negative and positive direction, respectively.
Objective: Describe the design and rational as well as baseline characteristics of two human intervention studies, within the Gut, Grain and Greens (3G) Center, investigating the effects of a gluten-poor and wholegrain-rich diet on microbiota composition and metabolic health.
Design: The gluten and wholegrain studies had a randomized, controlled, cross-over design each comprising two eight-week dietary intervention periods, separated by a six-week wash-out period. Each trial included 60 men and women exhibiting an increased metabolic risk. In the gluten study a gluten-poor diet was compared with a gluten-rich dietary fiber-controlled diet, and in the wholegrain study a wholegrain-rich diet was compared with a refined grain diet. The control diet was identical in both studies, being concomitantly high in gluten and refined. Participants substituted all cereal products with provided intervention products which they consumed ad libitum. Before and after each intervention period, fecal samples for quantitative metagenomic analyses were collected and an examination day was conducted. The primary outcome of the gluten intervention study was changes in the gut microbiota composition, while insulin sensitivity was an additional primary outcome of the wholegrain study. Further, a number of secondary outcomes were
Results: 52 and 50 participants completed the gluten and wholegrain intervention study, respectively. Participants had slightly elevated fasting glucose levels and increased waist circumference. Biological outcomes of the two studies will be published elsewhere.
Conclusion: The studies have the potential to provide new insights into the interplay of gut microbiota and metabolic health in individuals with increased risk of developing metabolic disorders.