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 investigation

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 investigation - Treatment of ADHD with Care as Usual vs Elimination diet - Brain effects

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45989

Enrollment

Registered

2018-11-05

Start date

2019-01-29

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD attention-deficit/hyperactivity disorder

Interventions

Intervention of the TRACE study: The ED trajectory consists of a 5-week elimination phase, in which children consume a standardized restricted diet, and a 9-12 months reintroduction phase to find th

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

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

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.)

Design outcomes

Primary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)