Neuroimaging of Diet in ADHD: Phase I

NCT ID: NCT01862484

Last Updated: 2015-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-12-31

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Restricted Diet

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

Group Type: EXPERIMENTAL

Restricted Diet

Intervention Type: DIETARY_SUPPLEMENT

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

Ruse Diet

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

Group Type: SHAM_COMPARATOR

Ruse Diet

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Restricted Diet

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

Intervention Type: DIETARY_SUPPLEMENT

Ruse Diet

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Steven Pliszka

Professor and Chief, Division of Child and Adolescent Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stevn R Pliszka, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Countries

United States

Other Identifiers

R21MH09680

Identifier Type: -

Identifier Source: org_study_id