ADHD attention deficit hyperactivity disorder ADHD attention deficit hyperactivity disorder
Conditions
Interventions
In the FFD group, after a 2-week baseline period (regular diet), participants
will follow a 5-week FFD preceded by a 1-week transition period followed by a
(maximum) 3-week challenge phase preceded
Sponsors
Wageningen Food Safety Research
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, a subject must meet all of the following criteria: • Meeting DSM-5 criteria of ADHD o Of the combined subtype o Current severity at least moderate AND Having an ARS score above 98th percentile for their age and gender • Fluent in Dutch • Aged 8 up to and including 11 years old • Right-handed • Children have given assent and both parents have provided informed consent • Children are willing, and able to miss 4 days of school • Children have permission from their principal to miss 4 days of school In the Dutch Compulsory Education law (Leerplichtwet 1969) article 11 it is stated that *parents/guardians are exempted from the obligation to ensure that the child regularly attends the school at which he is enrolled, if the child is prevented by other important circumstances from attending the school.* Regarding these important circumstances, article 14 mentions *The head may grant leave [..] for a maximum of ten days per school year in respect of the same child.* part of the number of days he is obliged to attend school under Article 4c.* Therefore, the decision on whether participating in academic research falls under *important circumstances* is then up to the principal.
Exclusion criteria
Exclusion criteria: • Current use of ADHD medication or behavioral therapy • Diagnosed chronic gastrointestinal disorder, i.e. inflammatory bowel disease, irritable bowel syndrome, celiac disease, non-celiac gluten-intolerance (gluten-sensitivity) or lactose-intolerance • Auto-immune disorder (e.g. diabetes mellitus type 1) • Vegetarian/vegan • Family circumstances that may compromise following or completion of the diet, including but not limited to family relational problems such as ongoing divorce/separation, conflict in the household, behavioral problems of a sibling • Having a contra-indication to MRI scanning (including, but not limited to): pacemakers and defibrillators, intraorbital or intraocular metallic fragments, ferromagnetic implants, claustrophobia. In line with international safety standards fMRI eligibility of implants and devices is based on the MRI safety list of Shellock, https://www.mrisafety.com/TMDL_list.php • Formal diagnosis Autism Spectrum Disorder • Formal diagnosis Developmental Coordination Disorder • Oxygen deprivation during birth: the newborn was ventilated with oxygen, had convulsions or had no sucking or swallowing reflex. • Use of systemic antibiotics, antifungals, antivirals or antiparasitics in the past six months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - ADHD symptoms over the three main measurement points T1 (before FFD or control period), T2 (after FFD or control period) and T3 (after challenge) If a significant effect is found on the ADHD symptoms: - Neural activation in the precuneus during the stop-signal task measured by functional magnetic resonance imaging (fMRI), at T1, T2 and T3. - Taxonomic composition and functional capacity of the gut microbiota at T1, T2 and T3. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Metabolomic, hormonal and immune signatures in urine and peripheral blood - Taxonomic composition of the oral microbiota - Ethylene (inflammation), Nitric Oxide (inflammation), Methane (gut microbiota functioning), Short-chain fatty acids (gut microbiota functioning) in exhaled breath - PUFA levels in peripheral blood - Physical complaints - ODD symptoms - Whole brain neural activation during the stop-signal task - Performance on the stop-signal task and stop-signal anticipation task | — |
Countries
Netherlands
Contacts
Public ContactF. Meer
Wageningen Research
Outcome results
None listed