The Lancet DOI:10.1016/S0140-6736(07)61306-3
September 6, 2007

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

Donna McCann, Angelina Barrett, Alison Cooper, Debbie Crumpler, Lindy Dalen, Kate Grimshaw, Elizabeth Kitchin, Kris Lok, Lucy Porteous, Emily Prince, Prof Edmund Sonuga-Barke, Prof John O Warner and Prof Jim Stevenson

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We undertook a randomised, double-blinded, placebo-controlled, crossover trial to test whether intake of artificial food colour and additives (AFCA) affected childhood behaviour.

153 3-year-old and 144 8/9-year-old children were included in the study. The challenge drink contained sodium benzoate and one of two AFCA mixes (A or B) or a placebo mix. The main outcome measure was a global hyperactivity aggregate (GHA), based on aggregated z-scores of observed behaviours and ratings by teachers and parents, plus, for 8/9-year-old children, a computerised test of attention. This clinical trial is registered with Current Controlled Trials (registration number ISRCTN74481308). Analysis was per protocol.

Conclusion:
Artificial colours or a sodium benzoate preservative (or both) in the diet result in increased hyperactivity in 3-year-old and 8/9-year-old children in the general population.

Discussion
. . . The present findings, in combination with the replicated evidence for the AFCA effects on the behaviour of 3-year-old children, lend strong support for the case that food additives exacerbate hyperactive behaviours (inattention, impulsivity, and overactivity) in children at least up to middle childhood. Increased hyperactivity is associated with the development of educational difficulties, especially in relation to reading, and therefore these adverse effects could affect the child's ability to benefit from the experience of schooling. These findings show that adverse effects are not just seen in children with extreme hyperactivity (ie, ADHD), but can also be seen in the general population and across the range of severities of hyperactivity. Our results are consistent with those from previous studies and extend the findings to show significant effects in the general population. The effects are shown after a rigorous control of placebo effects and for children with the full range of levels of hyperactivity.

We have found an adverse effect of food additives on the hyperactive behaviour of 3-year-old and 8/9-year-old children. Although the use of artificial colouring in food manufacture might seem superfluous, the same cannot be said for sodium benzoate, which has an important preservative function. The implications of these results for the regulation of food additive use could be substantial.