Neuroimaging of Diet in ADHD: Phase I

Study Overview
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Brief Summary
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Children with Attention Deficit Hyperactivity Disorder (ADHD) aged 9-12 years of age will be placed on a restriction diet for a 5 week period. Children will be randomized to either receive daily snacks that conform to the diet or will violate the diet (Ruse diet) in a double blind fashion. It is hypothesized that children who are consistently on the restricted diet (relative to those on the ruse diet) will show improvements in ADHD symptoms.

Detailed Description
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The ADHD rating scale (RS) will be the principal behavioral outcome measure. We hypothesize that children on restriction diet will have significantly lower ADHD RS scores after 5 weeks relative to the Ruse diet group. In addition children will undergo functional magnetic resonance imaging (fMRI) at baseline and again at 5 weeks. Children will perform a flanker task known to engage the dorsolateral prefrontal cortex (DLPFC) and the anterior cingulate cortex (ACC) during attention tasks. The children will also perform will look at pictures of appealing and unappealing food and rate whether they would like to eat it or not. This task is known to activate the ventral striatum (VS) (reward processing). A secondary hypothesis is whether children on the restricted diet will show changes in activity and connectivity of areas (DLPFC, ACC, VS) relative to those on the Ruse diet.

Official Title
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Neuroimaging of Diet and Medication in the Treatment of ADHD

Conditions
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Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
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* Dietary Supplement: Restricted Diet
* Dietary Supplement: Ruse Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 9-12 years Meets criteria for Attention Deficit Hyperactivity Disorder Parent must agree to use Study Diet Manual Exclusion Criteria: Any Axis I psychiatric disorder other than Oppositional Defiant Disorder or Anxiety Disorder not requiring psychopharmacological management Not currently on any pharmacological agent other than medication for ADHD

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Restricted Diet<br>Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet. | Dietary Supplement: Restricted Diet<br>* Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.<br>|
| Sham Comparator: Ruse Diet<br>Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet. | Dietary Supplement: Ruse Diet<br>* Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD Rating Scale IV | The ADHD Rating Scale is an 18 items scale containing items related to the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD). It is filled out by the parent. Each item is rated 0-3, the range of scores is 0 to 54, with 25 being the score below which the patient is considered to be in remission. Reference: DuPaul GJ, Power TJ, Anastopoulos AD, Reid R: ADHD Rating Scales-IV: Checklists, Norms and Clinical Interpretation. New York, Guilford Press; 1998. | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional Magnetic Resonance Imaging, ADHD, Diet