Dataset Information

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.

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.

SUBMITTER: Stobernack T

PROVIDER: S-EPMC6858247 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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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.

Stobernack Tim T de Vries Stefan P W SPW Rodrigues Pereira Rob R Pelsser Lidy M LM Ter Braak Cajo J F CJF Aarts Esther E van Baarlen Peter P Kleerebezem Michiel M Frankena Klaas K Hontelez Saartje S

BMJ open 20191105 11

<h4>Introduction</h4>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 i ...[more]

PMID: 31694844

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Project description:IntroductionDouble-blind placebo-controlled studies investigating the effect of a few-foods diet (FFD) on attention-deficit/hyperactivity disorder (ADHD) have provided consistent evidence that ADHD can be triggered by foods, indicating the existence of a food-induced ADHD subtype. In 2001 the "few-foods" approach was included in an ADHD treatment protocol. This approach consists of (a) determining, by means of an FFD, whether food is a trigger of ADHD; (b) reintroducing, in FFD responders, foods to assess which foods are incriminated; (c) finally composing a personalised diet eliminating the involved foods only. In the Netherlands the few-foods approach is applied in practice. We aimed to retrospectively assess its effectiveness on ADHD and oppositional defiant disorder (ODD) in real life.MethodsData from all children who started the few-foods approach in three specialised healthcare facilities during three consecutive months were included. Behavior was assessed at start and end of the 5-week FFD, using the ADHD Rating Scale and a structured psychiatric interview. Clinical responders (behavioral improvements ≥40%) proceeded with the reintroduction phase.ResultsData of 57 children, 27 taking medication and 15 following some elimination diet at start, were available. No differences were noted between parental scores of children with and without medication or some elimination diet at start. 21/27 (78%) children stopped taking medication during the FFD. 34/57 (60%) children were ADHD responders, 20/29 (65%) children meeting ODD criteria were ODD responders. 26/34 (76%) ADHD responders started the reintroduction phase; 14/26 (54%) still participated at six months. Teacher data were available of 18/57 (32%) children. 9/18 (50%) children were ADHD responders.ConclusionThe FFD, if applied by trained specialists, may lead to clinically relevant reduction of ADHD and ODD symptoms in general practice, and a concomitant decrease of ADHD medication. These results corroborate the existence of an ADHD subgroup with food-induced ADHD. Defining and eliminating the incriminated foods, i.e. the underlying causal triggers, may result in secondary prevention of food-induced ADHD. Research into underlying mechanism(s) is of vital importance: finding an easier method or biomarkers for diagnosing food-induced ADHD and ascertaining the incriminated foods may lead to redundancy of the few-foods approach.

Dataset Information

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.

Publications

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.

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