Attention Deficit-Hyperactivity DisorderBRAINNCT03440346
Biomarker Research in ADHD: the Impact of Nutrition
A study testing Few-foods diet in people with Attention Deficit-Hyperactivity Disorder, run by Wageningen University at 1 site in Netherlands.
Trial 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 is still unknown. It is a complex disorder with numerous contributing (epi)genetic and environmental factors. Read more about this study
- Who is it for?
- Ages 8 to 10 years, men only
- Conditions the study is for
- Attention Deficit-Hyperactivity Disorder
- What is being tested?
- Few-foods diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Feb 2018to 21 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Meeting DSM-IV ADHD criteria
- Male
- Aged 8 up to and including 10 years
- Right-handed
- Available to visit Wageningen University for 4 sessions (i.e. intake, screening, T1 and T2), of which 3 sessions including the child (screening, T1, T2)
- Upon study start, fully understanding and agreeing to the study objectives and having dated and signed an informed consent to participate in the study, including permission that material will be used or archived for (epi)genetic testing
- Willing to be informed about chance-findings that may have implications for the health of the child or his family, and approving of reporting this to the child's medical specialist or family's general physician.
- If the child uses "over the counter" medication, e.g. laxatives, melatonin for sleeping problems or hay fever medication, parents are asked to share the information leaflet, and if necessary participants are asked to change to alternatives that are free of additives that may affect ADHD, e.g. laxatives free of artificial sweeteners, sugar and cacao.
Who cannot join
- 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
- Auto-immune disorder (e.g. diabetes mellitus type 1)
- Vegetarian/vegan
Show all 15Show fewer
- Diagnosis dyslexia and/or dyscalculia
- IQ < 85
- Following behavioural therapy
- Use of ADHD medication
- Use of systemic antibiotics, antifungals, antivirals or antiparasitics in the past six months
- Insufficient command of the Dutch language by either parents or child that may affect understanding and execution of study and dietary instructions
- Family circumstances that may compromise following or completion of the diet, including but not limited to family relational problems
- Having a contra-indication to MRI scanning (including, but not limited to): pacemakers and defibrillators, intraorbital or intraocular metallic fragments, ferromagnetic implants, claustrophobia.
- Two weeks prior to the start of the study, dietary supplements (e.g. antioxidants, minerals, vitamins) or pro- or prebiotics use has to be stopped.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarker Research in ADHD: the Impact of Nutrition (BRAIN). An Open-label Trial to Investigate the Mechanisms Underlying the Effects of a Few-foods Diet on ADHD Symptoms in Children
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 is still unknown. It is a complex disorder with numerous contributing (epi)genetic and environmental factors. 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. To make this treatment easier or potentially obsolete, it is important to understand how and in which children an FFD affects ADHD symptoms.
Read more
The investigators hypothesise that an FFD affects brain function and behaviour, including ADHD symptoms, via the complex network of communication between the microbiota, gut and brain, i.e. the MGB axis. The aim of this study is to identify potential mechanism(s) underlying the impact of an FFD on ADHD symptoms and to identify biomarkers that predict the response to the FFD.
100 boys with ADHD will follow the FFD for 5 weeks. After inclusion, all participants will start with a baseline period, during which they will maintain their regular diet. The baseline period ends at the end of week 2. Thereafter, participants will follow a 5-week FFD, preceded by a 1-week transition period. The FFD period ends at the end of week 8.
At the end of the baseline period (i.e. at the end of week 2) and at the end of the FFD (i.e. at the end of week 8), fMRI scans will be made, blood and buccal saliva will be collected, and stool and urine will be handed in. Children will do computer tasks and parents will complete questionnaires to monitor ADHD and physical complaints. All samples will be analysed by researchers blinded to behavioural responses to the FFD. To assess the impact of the FFD on brain function and the MGB axis, associations between ADHD behavioural changes and changes in other primary and secondary study outcomes will be analysed.
This study may lead to the identification of biomarkers that can predict the response to an FFD. Understanding which changes - induced by an FFD - lead to improvements in ADHD symptoms may provide new avenues for developing treatments. Ultimately, the findings may enable personalised intervention strategies based on an individuals' configuration of the MGB axis.
- Conditions
- Attention Deficit-Hyperactivity Disorder
- Being tested
- Few-foods diet
- Keywords
- Attention Deficit Hyperactivity Disorder, ADHD, child, human, diet, few-foods diet, brain, gut, microbiota
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Few-foods dietOther
Also called Restricted Elimination Diet
The few-foods diet (FFD) is followed for 5-weeks preceded by a 1-week transition period during which the child's eating pattern will be gradually adjusted. The diet consists of rice, meat (turkey and lamb), a range of vegetables, pear, rice milk with added calcium and water, and is complemented with foods such as potatoes, fruits, corn, some sweets and wheat, which are allowed in small quantities only. Normal quantities of vegetables, rice and meat are allowed every day. If necessary the diet will be adjusted to avoid foods that the child dislikes or has cravings for. If the child does not respond to the initial FFD, i.e. no change in behaviour after the first two weeks, interim adjustments to the FFD will be made in consultation with the parents.
| Study group | Role | What they receive |
|---|---|---|
| Few-foods diet intervention | Experimental | Not described Receives: Other: Few-foods diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neural activation patterns during execution of tasks
Using fMRI, blood oxygen-level-dependent (BOLD) signal changes will be measured whilst performing cognitive tasks that assess inhibitory control and selective attention, i.e. a stop-signal task (response inhibition) and a Flanker task (response conflict and associated error monitoring). fMRI BOLD responses will be assessed between variable task-elements and performance. Region of interest (ROI; anatomically defined regions in the brain) analyses of the BOLD responses will be performed.
Measured: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in peripheral blood metabolite concentrations
Global metabolite profiles will be examined in plasma (or alternatively serum) obtained from whole blood using mass-spectrometry profiling. Phenylalanine and tyrosine plasma levels represent primary outcomes.
Measured: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in functional composition of the gut microbiota
Metagenome profiling will be performed on stool samples, leveraging Illumina next-generation sequencing technology. Sequence read data will be used for abundance profiling of microbiota genes that encode enzymes directly involved in the production or degradation of the dopamine and noradrenaline precursors phenylalanine and tyrosine.
Measured: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in ADHD symptom scores
ADHD symptoms will be scored using the 18-item ADHD rating scale, which is based on the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV and consists of 9 items that assess inattention and 9 items that focus on hyperactivity and impulsivity.
Measured: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Secondary outcomes (15)
Change in whole brain neural activation patterns during the execution of tasks
fMRI BOLD responses, assessed between variable task-elements, will be explored using whole brain imaging analyses.
Measured: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in whole brain functional connectivity at rest
A resting-state fMRI scan will be performed to analyse the networks of brain structures that are active during the resting-state.
Measured: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in taxonomic and functional composition of the gut microbiota
Stool metagenome and/or 16S ribosomal ribonucleic acid (rRNA) gene profiling will be performed using Illumina sequencing. Metagenome data will be used to determine the taxonomic and functional composition of the gut microbiota.
Measured: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in metabolite profiles
Global metabolite profiles will be examined in plasma (or alternatively serum) obtained from whole blood, urine and optionally in stool using mass-spectrometry profiling.
Measured: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in peripheral blood cell gene expression profiles
Peripheral blood mononuclear cells will be isolated from fasting blood samples and gene expression profiles will either be determined using Affymetrix gene expression arrays or by RNA-sequencing.
Measured: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in a panel of peripheral blood protein biomarkers related to immune, metabolic and neurological status
A large panel of proteins will be profiled using quantitative immunoassays or proteomics on blood plasma or serum.
Measured: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
DNA genotype
Genotyping will be conducted using a microarray platform on DNA isolated from buccal cells or on DNA isolated from whole blood.
Measured: Before the FFD diet intervention (i.e. at the end of week 2)
Change in DNA methylation profiles
Genome-wide profiling of DNA methylation status will be conducted using the Illumina Infinium MethylationEPIC beadchip microarray platform in DNA isolated from buccal cells or alternatively on DNA isolated from whole blood.
Measured: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in executive function
Executive functioning will be measured using a continuous performance test that assesses executive functions such as sustained attention and behavioural inhibition.
Measured: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in ADHD symptoms
Change will be scored using the Abbreviated Conners' scale
Measured: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in oppositional defiant disorder symptoms
Change will be scored using a validated questionnaire.
Measured: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in social behavioural problems
Change will be scored using the children's social and behavioural questionnaire.
Measured: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in physical complaints
Change will be scored using a validated questionnaire.
Measured: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in stool frequency
The child will record the frequency of defaecations for one week.
Measured: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in stool type
The child will type each stool using the modified Bristol stool scale form for children, which comprises 5 stool form types described and depicted in drawings.
Measured: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start19 Feb 2018
- Primary completion21 Jun 2019
- Study completion21 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit-Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- ADHD Research Centre
- Responsible party
- Sponsor
- Investigators
- Michiel Kleerebezem, Prof. dr., Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440346
- Sponsor's protocol ID
- NL63851.081.17
- Acronym
- BRAIN
- Status last verified
- Jun 2019
- First submitted
- 19 Jan 2018
- Last updated
- 1 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pelsser LM, Frankena K, Toorman J, Savelkoul HF, Dubois AE, Pereira RR, Haagen TA, Rommelse NN, Buitelaar JK. Effects of a restricted elimination diet on the behaviour of children with attention-deficit hyperactivity disorder (INCA study): a randomised controlled trial. Lancet. 2011 Feb 5;377(9764):494-503. doi: 10.1016/S0140-6736(10)62227-1.
PubMed 21296237Pelsser LM, Frankena K, Toorman J, Rodrigues Pereira R. Diet and ADHD, Reviewing the Evidence: A Systematic Review of Meta-Analyses of Double-Blind Placebo-Controlled Trials Evaluating the Efficacy of Diet Interventions on the Behavior of Children with ADHD. PLoS One. 2017 Jan 25;12(1):e0169277. doi: 10.1371/journal.pone.0169277. eCollection 2017.
PubMed 28121994Stobernack T, de Vries SPW, Rodrigues Pereira R, Pelsser LM, Ter Braak CJF, Aarts E, van Baarlen P, Kleerebezem M, Frankena K, Hontelez S. 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. BMJ Open. 2019 Nov 5;9(11):e029422. doi: 10.1136/bmjopen-2019-029422.
PubMed 31694844
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Research in ADHD: the Impact of Nutrition (BRAIN). An Open-label Trial to Investigate the Mechanisms Underlying the Effects of a Few-foods Diet on ADHD Symptoms in Children
- ClinicalTrials.gov ID
- NCT03440346
- Acronym / sponsor ID
- BRAIN / NL63851.081.17
- Conditions
- Attention Deficit-Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, ADHD, child, human, diet, few-foods diet, brain, gut
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- ADHD Research Centre
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 is still unknown. It is a complex disorder with numerous contributing (epi)genetic and environmental factors. 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. To make this treatment easier or potentially obsolete, it is important to understand how and in which children an FFD affects ADHD symptoms.
The investigators hypothesise that an FFD affects brain function and behaviour, including ADHD symptoms, via the complex network of communication between the microbiota, gut and brain, i.e. the MGB axis. The aim of this study is to identify potential mechanism(s) underlying the impact of an FFD on ADHD symptoms and to identify biomarkers that predict the response to the FFD.
100 boys with ADHD will follow the FFD for 5 weeks. After inclusion, all participants will start with a baseline period, during which they will maintain their regular diet. The baseline period ends at the end of week 2. Thereafter, participants will follow a 5-week FFD, preceded by a 1-week transition period. The FFD period ends at the end of week 8.
At the end of the baseline period (i.e. at the end of week 2) and at the end of the FFD (i.e. at the end of week 8), fMRI scans will be made, blood and buccal saliva will be collected, and stool and urine will be handed in. Children will do computer tasks and parents will complete questionnaires to monitor ADHD and physical complaints. All samples will be analysed by researchers blinded to behavioural responses to the FFD. To assess the impact of the FFD on brain function and the MGB axis, associations between ADHD behavioural changes and changes in other primary and secondary study outcomes will be analysed.
This study may lead to the identification of biomarkers that can predict the response to an FFD. Understanding which changes - induced by an FFD - lead to improvements in ADHD symptoms may provide new avenues for developing treatments. Ultimately, the findings may enable personalised intervention strategies based on an individuals' configuration of the MGB axis.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Few-foods diet intervention | Experimental | Other: Few-foods diet |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Meeting DSM-IV ADHD criteria
- Male
- Aged 8 up to and including 10 years
- Right-handed
- Available to visit Wageningen University for 4 sessions (i.e. intake, screening, T1 and T2), of which 3 sessions including the child (screening, T1, T2)
Key exclusion criteria (15 listed)
- 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
- Auto-immune disorder (e.g. diabetes mellitus type 1)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Few-foods dietAlso: Restricted Elimination DietThe few-foods diet (FFD) is followed for 5-weeks preceded by a 1-week transition period during which the child's eating pattern will be gradually adjusted. The diet consists of rice, meat (turkey and lamb), a range of vegetables, pear, rice milk with added calcium and water, and is complemented with foods such as potatoes, fruits, corn, some sweets and wheat, which are allowed in small quantities only. Normal quantities of vegetables, rice and meat are allowed every day. If necessary the diet will be adjusted to avoid foods that the child dislikes or has cravings for. If the child does not respond to the initial FFD, i.e. no change in behaviour after the first two weeks, interim adjustments to the FFD will be made in consultation with the parents. | Other | Few-foods diet intervention |
Primary outcome
Change in neural activation patterns during execution of tasks
Time frame: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Using fMRI, blood oxygen-level-dependent (BOLD) signal changes will be measured whilst performing cognitive tasks that assess inhibitory control and selective attention, i.e. a stop-signal task (response inhibition) and a Flanker task (response conflict and associated error monitoring). fMRI BOLD responses will be assessed between variable task-elements and performance. Region of interest (ROI; anatomically defined regions in the brain) analyses of the BOLD responses will be performed.
Change in peripheral blood metabolite concentrations
Time frame: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Global metabolite profiles will be examined in plasma (or alternatively serum) obtained from whole blood using mass-spectrometry profiling. Phenylalanine and tyrosine plasma levels represent primary outcomes.
Change in functional composition of the gut microbiota
Time frame: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Metagenome profiling will be performed on stool samples, leveraging Illumina next-generation sequencing technology. Sequence read data will be used for abundance profiling of microbiota genes that encode enzymes directly involved in the production or degradation of the dopamine and noradrenaline precursors phenylalanine and tyrosine.
Change in ADHD symptom scores
Time frame: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
ADHD symptoms will be scored using the 18-item ADHD rating scale, which is based on the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV and consists of 9 items that assess inattention and 9 items that focus on hyperactivity and impulsivity.
15 secondary outcomes
Change in whole brain neural activation patterns during the execution of tasks
Time frame: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in whole brain functional connectivity at rest
Time frame: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in taxonomic and functional composition of the gut microbiota
Time frame: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in metabolite profiles
Time frame: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in peripheral blood cell gene expression profiles
Time frame: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in a panel of peripheral blood protein biomarkers related to immune, metabolic and neurological status
Time frame: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
DNA genotype
Time frame: Before the FFD diet intervention (i.e. at the end of week 2)
Change in DNA methylation profiles
Time frame: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in executive function
Time frame: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in ADHD symptoms
Time frame: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in oppositional defiant disorder symptoms
Time frame: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in social behavioural problems
Time frame: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in physical complaints
Time frame: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in stool frequency
Time frame: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Change in stool type
Time frame: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
- Background: PubMed 21296237Pelsser LM, Frankena K, Toorman J, Savelkoul HF, Dubois AE, Pereira RR, Haagen TA, Rommelse NN, Buitelaar JK. Effects of a restricted elimination diet on the behaviour of children with attention-deficit hyperactivity disorder (INCA study): a randomised controlled trial. Lancet. 2011 Feb 5;377(9764):494-503. doi: 10.1016/S0140-6736(10)62227-1.
- Background: PubMed 28121994Pelsser LM, Frankena K, Toorman J, Rodrigues Pereira R. Diet and ADHD, Reviewing the Evidence: A Systematic Review of Meta-Analyses of Double-Blind Placebo-Controlled Trials Evaluating the Efficacy of Diet Interventions on the Behavior of Children with ADHD. PLoS One. 2017 Jan 25;12(1):e0169277. doi: 10.1371/journal.pone.0169277. eCollection 2017.
- Derived from this study: PubMed 31694844Stobernack T, de Vries SPW, Rodrigues Pereira R, Pelsser LM, Ter Braak CJF, Aarts E, van Baarlen P, Kleerebezem M, Frankena K, Hontelez S. 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. BMJ Open. 2019 Nov 5;9(11):e029422. doi: 10.1136/bmjopen-2019-029422.
- BRAIN-study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michiel Kleerebezem, Prof. dr. principal investigator
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Few-foods diet in people with Attention Deficit-Hyperactivity Disorder, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neural activation patterns during execution of tasks (time frame: Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03440346, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2019.