Skip to main content
OpenTrials
Completed

NCT Number: NCT01862484

Neuroimaging of Diet in ADHD: Phase I

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Restricted Diet

Dietary Supplement

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

Ruse Diet

Dietary Supplement

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

Neuroimaging of Diet and Medication in the Treatment of ADHD

Acronym: FTF

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 24, 2013
Registry last updated
Mar 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.