Neuroimaging of Diet in ADHD: Phase I (FTF)

The University of Texas System (UT)

Status: Completed

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Dietary Supplement: Restricted Diet; Dietary Supplement: Ruse Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT01862484

R21MH09680

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 9 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Restricted Diet

Experimental group

Description:

Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.

Treatment:

Dietary Supplement: Restricted Diet

Ruse Diet

Sham Comparator group

Description:

Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.

Treatment:

Dietary Supplement: Ruse Diet