A Two Arm Randomized Clinical Trial comparing the effects of an Elimination Diet and a Healthy Diet in Children with ADHD (TRACE Study). Effects on the Brain * an exploratory investigatio

Recruiting

• Conditions: ADHD; attention-deficit/hyperactivity disorder; 10009841

• Registration Number: NL-OMON45989
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

-clinical ADHD diagnosis according to DSM-V
-treatment naive
-6-12 years old
-ADHD Rating Scale (ARS) score higher than 1.5 SD above the mean
-conformed diagnosis by structured psychiatric interview (K-SADS) with parents.

Exclusion Criteria

- children already being treated for ADHD (either medication or therapy or diet)
- use of any other psychotropic medication
- inadequate mastery of the Dutch language
- presence of claustrophobia
- MRI incompatibility (due to metal parts in the body etc.)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints: In TRACE-MRI, the outcome parameters include:<br /><br>neural architecture (brain structure, function and connectivity (only for<br /><br>children who are 6 years and older) based on MRI-scans acquired at two<br /><br>timepoints (T0 en T1) in the Donders Centre for Cognitive Neuroimaging in<br /><br>Nijmegen. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>