Neuroimaging of Diet in ADHD: Phase I

Not Applicable

Completed

• Conditions: Attention Deficit Disorder With Hyperactivity
• Interventions: Dietary Supplement: Restricted Diet; Dietary Supplement: Ruse Diet

• Registration Number: NCT01862484
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief 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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-17
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-24
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2015-02-03
• Status Verified: 2015-03
• Results First Submitted QC: 2015-03-10
• Last Update Submitted: 2015-03-10
• Results First Posted: 2015-03-13
• Last Update Posted: 2015-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
ADHD Rating Scale IV	5 weeks	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.

Trial Locations

Locations (1)

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States