Biomarker Research in ADHD: the Impact of Nutrition: An open-label trial to investigate the mechanisms underlying the effects of a few-foods diet on ADHD symptoms in childre

Completed

Conditions: HKS (Hyperkinetic Syndrome) hyperactivity
10037173

Registration Number: NL-OMON46639

Lead Sponsor: Wageningen Universiteit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Meeting DSM-IV ADHD criteria
Male
Aged 8 up to and including 10 years
Right-handed

Exclusion Criteria

Diagnosis Autism Spectrum Disorder
Diagnosis Developmental Coordination Disorder
Premature birth (< 36 weeks) and/or oxygen deprivation during birth
Diagnosed chronic gastrointestinal disorder, i.e. inflammatory bowel disease, irritable bowel syndrome, celiac disease, non-celiac gluten-intolerance (gluten-sensitivity) or lactose-intolerance
Vegetarian/vegan
Diagnosis dyslexia and/or dyscalculia
IQ < 85
Taking ADHD medication or following behavioural therapy
Use of systemic antibiotics, antifungals, antivirals or antiparasitics in past 6 months
Insufficient command of the Dutch language by either parents or child
Family circumstances that may compromise following or completion of the diet
Having a contra-indication to MRI scanning
Two weeks prior to the start of the study, dietary supplements (e.g. antioxidants, minerals, vitamins) or pro- or prebiotics use have to be stopped.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>ADHD symptoms, measured with validated behavioural questionnaires, in relation<br /><br>to neural activation in the frontal and striatal regions during cognitive tasks<br /><br>measured by functional magnetic resonance imaging (fMRI), abundance of genes<br /><br>encoding phenylalanine and tyrosine metabolism enzymes in the gut microbiota,<br /><br>and peripheral blood levels of phenylalanine and tyrosine.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome parameters include the assessment of whole brain neural<br /><br>activation patterns during execution of tasks and functional connectivity at<br /><br>rest, executive functioning, comorbid psychiatric disorders, as well as MGB<br /><br>axis parameters, including taxonomic and functional composition of the gut<br /><br>microbiota, peripheral blood mononuclear cell gene expression, peripheral blood<br /><br>metabolites, peripheral blood protein biomarkers, urine metabolites, and DNA<br /><br>genotype and methylation in buccal cells.</p><br>