1) Identify potential mechanism(s) underlying the impact of an FFD on ADHD symptoms;2) Identify biomarkers that predict the response to the FFD.
ID
Source
Brief title
Condition
- Psychiatric and behavioural symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Attention deficit hyperactivity disorder (ADHD) is the most common childhood
behavioural disorder, causing significant impediment to a child*s development.
The exact aetiology of ADHD, a complex disorder with numerous contributing
(epi)genetic and environmental factors, is still unknown. Currently, treatment
predominantly consists of behavioural and pharmacological therapy. However,
medication use 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 effect of a few-foods diet (FFD) has demonstrated large
improvements in ADHD symptoms. However, following an FFD requires great effort
of both the child and parents, hence limiting its applicability as an ADHD
treatment. To make this treatment easier, more effective or potentially
obsolete, we need to understand how and in which children an FFD affects ADHD
symptoms. We hypothesise that an FFD affects brain function and behaviour,
including ADHD symptoms, and that nutritional impact on brain function is
effectuated via the complex network of communication between the microbiota,
gut and brain, i.e. the MGB axis.
Study objective
1) Identify potential mechanism(s) underlying the impact of an FFD on ADHD
symptoms;
2) Identify biomarkers that predict the response to the FFD.
Study design
An open-label trial with researchers blinded to changes in ADHD symptoms during
sample processing and initial data analyses.
Intervention
After a 2-week baseline period (regular diet) participants will follow a 5-week
FFD preceded by a 1-week transition period.
Study burden and risks
Previous research has demonstrated that following an FFD can lead to a
reduction of ADHD-symptoms. The current study therefore includes a
therapeutically active intervention. Participants will follow a 5-week FFD,
which may be considered burdensome. During one week in the baseline period and
during the FFD phase, parents will record food intake, daily activities and the
child*s behaviour; the child will record stool frequency and type. As part of
the screening procedure, the paediatrician will verify the ADHD diagnosis or
will make a research diagnosis and will conduct a physical examination of the
child; children that are deemed eligible for participation will undergo a mock
fMRI scan and an intelligence quotient (IQ) test (the latter only if not
conducted in the past year). At the start and end of the FFD, children will
undergo: fMRI, Quantitative behaviour test, a buccal swab, blood collection (15
ml), and self-collection of stool and urine samples. Parents will complete
questionnaires to monitor ADHD and comorbidities To reduce the burden due to
traveling, the child and parents can stay overnight in a hotel in close
proximity to the WU, if they wish. This will be directly organised by the WU.
There is a possibility for chance-findings of pathology in the MRI and
laboratory analyses or of an indication of a genetic defect during genotyping.
Children are not exposed to other risks when participating in this study.
Participants receive the diagnostic FFD research and the IQ-test free of
charge; both are currently not or only partially covered by health insurance
companies. Travel, hotel and parking expenses will be compensated and children
will receive a small gift after each measurement session and an USB drive with
an MRI image of their brain after the last fMRI scan.
The personal benefit for participating in the study is the possibility to
receive an individually tailored FFD that may reduce ADHD symptoms and often
occurring comorbid conditions, which may improve the child*s wellbeing
considerably and lead to better future prospects. Moreover, it may diminish
(future) medication use and its associated side effects. Most importantly, if
this study identifies biomarkers of food-related ADHD or new targets to treat
food-related ADHD, the results may potentially lead to novel future diagnostic
and/or treatment prospects for children with ADHD, including those
participating in this study.
De Elst 1
Wageningen 6708 WD
NL
De Elst 1
Wageningen 6708 WD
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63851.081.17 |