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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 children

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 children - BRAIN study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46639
Enrollment
100
Registered
2018-02-01
Start date
2018-02-19
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HKS (Hyperkinetic Syndrome) hyperactivity

Interventions

After a 2-week baseline period (regular diet) participants will follow a 5-week FFD preceded by a 1-week transition period.

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Diagnosis Autism Spectrum Disorder Diagnosis Developmental Coordination Disorder Premature birth (

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)