Contact information
Type
Scientific
Primary contact
Prof Jim Stevenson
ORCID ID
Contact details
School of Psychology
University of Southampton
Highfield
Southampton
SO17 1BJ
United Kingdom
+44 (0)23 8059 2583
jsteven@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
pwh/ab/16/1/2491
Study information
Scientific title
Acronym
FABiC - Food And Behaviour in Children
Study hypothesis
1. Do children show a behavioural response to the withdrawal and introduction of artificial food colourings and preservatives (AFCPs)?
2. What are the characteristics that differentiate responders to AFCPs and non-responders baseline attention deficit hyperactivity disorder (ADHD) symptom severity and/or their genotype?
3. Can any response that is found in the stage one trial be replicated in a blind acute challenge?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Hyperactivity
Intervention
A within subject double blind food challenge exposure to two additive mixes and one placebo mix - all children receiving all mixtures in a randomised order
Intervention type
Drug
Phase
Not Specified
Drug names
Artificial food colourings and preservatives (AFCPs)
Primary outcome measures
1. Direct observation of classroom behaviour
2. Parent and teacher ratings of hyperactive behaviour
3. Continuous performance test assessment of sustained attention
Secondary outcome measures
Sleep
Overall trial start date
01/03/2005
Overall trial end date
28/02/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Stage 1 - Chronic exposure - 120 three year old children and 120 eight year old children from the general population.
Stage 2 - Acute exposure - 45 eight year old children selected as being responders or non-responders in the Stage 1 challenge.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
153 3 year-olds and 144 8/9 year-olds
Participant exclusion criteria
Those on special diets.
Recruitment start date
01/03/2005
Recruitment end date
28/02/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Psychology
Southampton
SO17 1BJ
United Kingdom
Sponsor information
Organisation
University of Southampton (UK)
Sponsor details
Research Support Office
University of Southampton
Highfield
Southampton
SO17 1BJ
United Kingdom
+44 (0)23 8059 8672
info@rso.soton.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Food Standards Agency (UK) (Grant T07040)
Alternative name(s)
FSA
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17825405
Publication citations
-
Results
McCann D, Barrett A, Cooper A, Crumpler D, Dalen L, Grimshaw K, Kitchin E, Lok K, Porteous L, Prince E, Sonuga-Barke E, Warner JO, Stevenson J, Food additives and hyperactive behaviour in 3-year-old and 8/9-year-old children in the community: a randomised, double-blinded, placebo-controlled trial., Lancet, 2007, 370, 9598, 1560-1567, doi: 10.1016/S0140-6736(07)61306-3.