Biomarker Research in ADHD: the Impact of Nutrition (BRAIN) - study protocol of an open-label trial to investigate the mechanisms underlying the effects of a few-foods diet on ADHD symptoms in children

Tim Stobernack, Stefan P W de Vries, Rob Rodrigues Pereira, Lidy M Pelsser, Cajo J F Ter Braak, Esther Aarts, Peter van Baarlen, Michiel Kleerebezem, Klaas Frankena, Saartje Hontelez, Tim Stobernack, Stefan P W de Vries, Rob Rodrigues Pereira, Lidy M Pelsser, Cajo J F Ter Braak, Esther Aarts, Peter van Baarlen, Michiel Kleerebezem, Klaas Frankena, Saartje Hontelez

Abstract

Introduction: Attention deficit hyperactivity disorder (ADHD) is the most common childhood behavioural disorder, causing significant impediment to a child's development. It is a complex disorder with numerous contributing (epi)genetic and environmental factors. Currently, treatment consists of behavioural and pharmacological therapy. However, ADHD medication is associated with several side effects, and concerns about long-term effects and efficacy exist. Therefore, there is considerable interest in the development of alternative treatment options. Double-blind research investigating the effects of a few-foods diet (FFD) has demonstrated a significant decrease in ADHD symptoms following an FFD. However, an FFD requires a considerable effort of both child and parents, limiting its applicability as a general ADHD treatment. To make FFD intervention less challenging or potentially obsolete, we need to understand how, and in which children, an FFD affects ADHD behaviour and, consequently, the child's well-being. We hypothesise that an FFD affects brain function, and that the nutritional impact on ADHD is effectuated by a complex interplay between the microbiota, gut and brain, that is, the microbiota-gut-brain axis.

Methods and analysis: The Biomarker Research in ADHD: the Impact of Nutrition (BRAIN) study is an open-label trial with researchers blinded to changes in ADHD symptoms during sample processing and initial data analyses.

Ethics and dissemination: The Medical Research and Ethics Committee of Wageningen University has approved this study (NL63851.081.17, application 17/24). Results will be disseminated through peer-reviewed journal publications, conference presentations, (social) media and the BRAIN study website. A summary of the findings will be provided to the participants.

Trial registration number: NCT03440346.

Study dates: Collection of primary outcome data started in March 2018 and will be ongoing until 100 children have participated in the study. Sample data analysis will start after all samples have been collected.

Keywords: ADHD; biomarker; brain activity; fMRI; few-foods diet; microbiota.

Conflict of interest statement

Competing interests: LMP works at the Pelsser RED Centrum supervising the diagnostic procedure to assess the effect of an FFD on the behaviour of children with ADHD.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Schematic overview of the BRAIN study design. FFD, few-foods diet. BRAIN, Biomarker Research in ADHD: the Impact of Nutrition.

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