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

Sabine Ibrügger1, Rikke Juul Gøbel2, Henrik Vestergaard2, Tine Rask Licht3, Hanne Frøkiær4, Allan Linneberg5-7, Torben Hansen2, Ramneek Gupta8, Oluf Pedersen2, Mette Kristensen1 and Lotte Lauritzen1*

1Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Rolighedsvej 30, 1958 Frederiksberg C, Denmark
2The Novo Nordisk Foundation Center for Basic Metabolic Research, Section of Metabolics Genetics, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 1, 2100 København Ø, Denmark
3Division of Food Microbiology, Technical University of Denmark, National Food Institute, Mørkhøj Bygade 19, 2860 Søborg, Denmark
4Department of Veterinary Disease Biology, Faculty of Health and Medical Sciences, University of Copenhagen, Ridebanevej 9, 1870 Frederiksberg C, Denmark
5Department of Clinical Experimental Research, Glostrup University Hospital, Nordre Ringvej 57, 2600 Glostrup Denmark
6Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark
7Research Centre for Prevention and Health, the Capital Region of Denmark, Denmark
8Department of Systems Biology, Center for Biological Sequence Analysis, Technical University of Denmark, Kemitorvet, 2800 Kgs. Lyngby, Denmark


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 investigated.

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.

Journal of Clinical Trials 2014, 4:4

20 JUNE 2024