Neuroimaging of Diet in ADHD: Phase I (FTF)

• ClinicalTrials.gov Identifier: NCT01862484
• Recruitment Status: Completed
• First Posted: May 24, 2013
• Results First Posted: March 13, 2015
• Last Update Posted: March 13, 2015
• Sponsor: The University of Texas Health Science Center at San Antonio
• Information provided by (Responsible Party): Steven Pliszka, The University of Texas Health Science Center at San Antonio

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Attention Deficit Disorder With Hyperactivity	Dietary Supplement: Restricted Diet; Dietary Supplement: Ruse Diet	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Neuroimaging of Diet and Medication in the Treatment of ADHD
• Study Start Date: May 2013
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Restricted Diet; Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.	Dietary Supplement: Restricted Diet; Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.
Sham Comparator: Ruse Diet; Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.	Dietary Supplement: Ruse Diet; Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet

Outcome Measures

Primary Outcome Measures :

1. ADHD Rating Scale IV [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 9 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Texas

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States, 78229

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

Investigators

• Principal Investigator: Stevn R Pliszka, MD; The University of Texas Health Science Center at San Antonio

More Information

• Responsible Party: Steven Pliszka, Professor and Chief, Division of Child and Adolescent Psychiatry, The University of Texas Health Science Center at San Antonio
• ClinicalTrials.gov Identifier: NCT01862484
• Other Study ID Numbers: R21MH09680
• First Posted: May 24, 2013
• Results First Posted: March 13, 2015
• Last Update Posted: March 13, 2015
• Last Verified: March 2015

Keywords provided by Steven Pliszka, The University of Texas Health Science Center at San Antonio:

ADHD; Diet; Functional Magnetic Resonance Imaging

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders