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Neuroimaging of Diet in ADHD: Phase I (FTF)

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Restricted Diet
Ruse Diet
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD, Diet, Functional Magnetic Resonance Imaging

Eligibility Criteria

9 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Restricted Diet

Ruse Diet

Arm Description

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

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

Outcomes

Primary Outcome Measures

ADHD Rating Scale IV
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.

Secondary Outcome Measures

Full Information

First Posted
May 17, 2013
Last Updated
March 10, 2015
Sponsor
The University of Texas Health Science Center at San Antonio
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1. Study Identification

Unique Protocol Identification Number
NCT01862484
Brief Title
Neuroimaging of Diet in ADHD: Phase I
Acronym
FTF
Official Title
Neuroimaging of Diet and Medication in the Treatment of ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
ADHD, Diet, Functional Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Restricted Diet
Arm Type
Experimental
Arm Description
Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.
Arm Title
Ruse Diet
Arm Type
Sham Comparator
Arm Description
Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.
Intervention Type
Dietary Supplement
Intervention Name(s)
Restricted Diet
Intervention Description
Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ruse Diet
Intervention Description
Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet
Primary Outcome Measure Information:
Title
ADHD Rating Scale IV
Description
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.
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stevn R Pliszka, MD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Neuroimaging of Diet in ADHD: Phase I

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