The objective of the present study is to investigate whether a diet rich in n-3 fatty acids (DHA/EPA) can improve brain activation patterns assiociated with cognitive control in children with ADHD .
ID
Source
Brief title
Condition
- Developmental disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is changes in MR signal with n-3 supplementation.
Secondary outcome
The secondary outcome measures are changes with n-3 supplementation in:
1) cognitive control (Accuracy and RT on the go/no-go task)
2) ADHD symptoms
3) fatty acid status assessed in cheek cells
4) dopamine metabolites assessed in urine
Background summary
Children with ADHD have been shown to have a lower status of the n-3 fatty acid
DHA compared to healthy
children. Moreover, some clinical trials have shown that EPA and DHA
supplementation of children with ADHD
may alleviate symptomatology and may improve cognitive performance.
Study objective
The objective of the present study is to investigate whether a diet rich in n-3
fatty acids (DHA/EPA) can
improve brain activation patterns assiociated with cognitive control in
children with ADHD .
Study design
Randomized, placebo controled, double-blind, parallel design, where children
with and without ADHD receive a
food supplement for 16 weeks (n-3 fatty acids or placebo) and participate in a
pre- and post-measurement
using fMRI.
Intervention
The intervention group will receive 10 grams of margarine enriched with n-3
daily for 16 weeks. The placebo
group will receive a similar product, without the n-3 enrichment.
Study burden and risks
The overall burden and risks of the study are minimal. DHA and EPA will be
integrated in a regular dietary
product (margarine), which has been tested for microbiological and general
safety. All ingredients are food
grade. No specific risks exist for the intervention product. The study will
involve five site visits for participants
and their parents. During the visits at the start and at the end of the
intervention children will participate in an
fMRI-scan and a protocolized simulation session. The purpose of this session is
to prepare children for the
fMRI-scan and to assess whether they are willing to and capable of
participating in the actual session. Parents
and teachers of children will be asked to fill out questionnaires pertaining to
the child*s behaviour, dietary fat
intake and to assess symptoms of fatty acid deficiency. For each questionnaire
this will take between 5 and 20
minutes of their time. At all five visits, participants will be asked to fill
out additional questionnaires (on dietary
fat intake and ADHD behaviour) and to donate urine samples. Before the start of
the intervention and after
completion, buccal cells will be collected by means of a cheek swab.
Olivier van Noortlaan 120
3133 AT Vlaardingen
NL
Olivier van Noortlaan 120
3133 AT Vlaardingen
NL
Listed location countries
Age
Inclusion criteria
General:
1) 8-14 year old boys
2) Used to daily consumption of margarine
3) Sufficient mastery of the Dutch language of both the subject and his parents
ADHD-group:
1)DSM-IV (APA, 1994) diagnosis of ADHD, according to DISC interview
2) Scores in the clinical range on the Child Behaviour Checklist (CBCL) and Teacher Rating Form(TRF)
Exclusion criteria
1) mental retardation (IQ < 70)
2) major illness of the cardiovascular, the endocrine, the pulmonary or the gastrointestinal system
3) presence of metal objects in or around the body (pacemaker, dental braces)
4) history of or present neurological disorder
5) regular use of n-3 or n-6 fatty acid dietary supplements, products fortified with EPA or DHA, a regular diet high in fatty fish in the four months prior to study participation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL24118.041.08 |