NCT01862484

Neuroimaging of Diet in ADHD: Phase I

Neuroimaging of Diet and Medication in the Treatment of ADHD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 9 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Attention Deficit Disorder With Hyperactivity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Restricted Diet	Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.
DIETARY_SUPPLEMENT	Ruse Diet	Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-05-24
• Last updated: 2015-03-13
• Results posted: 2015-03-13

Locations

1 site across 1 country: United States