http://www.medscape.com/viewarticle/562631?src=mp
September 10, 2007 — Artificial food color and additives commonly found in children's food increase the mean level of hyperactivity in children aged 3 years and 8 to 9 years, according to the results of a community-based, randomized, double-blind, placebo-controlled food challenge study published online September 6 in The Lancet.
"Artificial food colours and other food additives (AFCA) have long been suggested to affect behaviour in children," write Donna McCann, PhD, from the University of Southampton in the United Kingdom, and colleagues. "Despite the failure of early studies to identify the range of proposed adverse affects, a recent meta-analysis of double-blinded, placebo-controlled trials has shown a significant effect of AFCA on the behaviour of children with ADHD [attention-deficit/hyperactivity disorder]. The possible benefit in a reduction in the level of hyperactivity of the general population by the removal of AFCA from the diet is less well established."
The investigators randomized 153 three-year-old and 144 eight- to nine-year-old children to receive a challenge drink containing sodium benzoate and 1 of 2 artificial-food-color-and-additive mixes (A or B) or a placebo mix. The primary outcome measure was a global hyperactivity aggregate, derived from aggregated z scores of observed behaviors and teacher and parent ratings, as well as from a computerized test of attention for 8- to 9-year-old children.
For reasons not related to childhood behavior, 16 three-year-old children and 14 eight- to nine-year-old children dropped out of the study. Compared with placebo, mix A, but not mix B, had a significantly adverse effect on the global hyperactivity aggregate for all 3-year-old children (effect size, 0.20; 95% confidence interval [CI], 0.01 - 0.39; P = .044). When the analysis was restricted only to those 3-year-old children who consumed more than 85% of juice and had no missing data, the findings were similar (effect size, 0.32; 95% CI, 0.05 - 0.60; P = .02).
For 8- to 9-year-old children who consumed at least 85% of drinks and had no missing data, there were significantly adverse effects compared with placebo for either mix A (effect size, 0.12; 95% CI, 0.02 - 0.23; P = .023) or mix B (effect size, 0.17; 95% CI, 0.07 - 0.28; P = .001).
"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," the authors write. "We recorded substantial individual differences in the response of children to the additives. For both age groups, no significant effect of social and demographic factors was seen on the initial level of GHA [global hyperactivity aggregate] or in the moderation of the challenge effects."
Study limitations include inability to determine specific compounds in the mix that are harmful and lack of control over when the challenges are ingested in relation to the timing of measures of hyperactivity.
"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 authors conclude. "The implications of these results for the regulation of food additive use could be substantial."
The Food Standards Agency funded this study. The authors have disclosed no relevant financial relationships.
Lancet. Published online September 6, 2007.
Clinical Context
According to the authors of the current study, artificial food colors and additives have been shown to affect behavior in children, with an increase in overactive, impulsive, and inattentive behavior, (ie, hyperactivity, similar to that seen in children with ADHD). A recent meta-analysis showed a significant effect of artificial food color and additives on the behavior of children with ADHD, with an effect size of 0.21 to 0.28.
This is a community-based, double-blind, placebo-controlled, within-subject, crossover, food challenge study designed to examine the effect of 2 types of artificial food color and additive preparations (representing typical consumption of sweets or candies) on 3- and 8- to 9-year-old children.
Study Highlights
Included were 3-year-old children from nurseries, preschool groups, and play groups and schoolchildren aged 8 to 9 years from 1 city in England.
Teachers completed a baseline hyperactivity questionnaire for all children.
Dieticians completed a food intake report based on 24-hour recall to assess the amount of food consumed with food additives and coloring.
3 drink mixes were used to represent typical daily sweet intakes for children in this area.
Mix A for the 3-year-old children included 20 mg of artificial food colorings (sunset yellow, 5 mg; carmoisine, 2.5 mg; tartrazine, 7.5 mg; and ponceau 4R, 5 mg) and 45 mg of sodium benzoate.
Mix B contained 30 mg of artificial food colorings and 45 mg of sodium benzoate.
For 9-year-old children, the total amount of artificial coloring was multiplied by 1.25 to reflect higher intakes by children in this age group, but 45 mg of sodium benzoate was used for mixes A and B.
Doses for mix A were similar to those in two 56-g bags of sweets and, for mix B, 4 bags of sweets daily.
Children were randomized to 1 of 6 sequences for 6 weeks of mix A, mix B, or placebo.
Children spent a week consuming their typical diet followed by a washout period of 6 weeks.
During this 6-week period, children consumed the challenge mix and mixed fruit juices at home, provided in identical sealed bottles.
A separate masked test in young adults showed that the 3 drinks could not be differentiated by taste or appearance.
Parents completed a daily diary of juice mix consumption.
A global hyperactivity aggregate (with higher score representing more hyperactivity) was calculated, based on 3 measures in 3-year-old children and 4 measures in 8- to 9-year-old children.
The 3 measures used for both age groups were ADHD rating scale IV (for teachers), Weiss-Perry-Peters hyperactivity scale for parents, and the classroom observation code used by trained observers.
A fourth measure for 8- to 9-year-old children only was the Conners continuous performance test II using 4 scores and visual stimuli of 14-minutes' duration to assess hyperactivity.
The global hyperactivity aggregate was a composite of the tests used with baseline score standardized as 0.
85% of children were white, 33% to 43% of parents had lower occupations, and 82% were married or cohabiting.
3-year-old children (n = 136):
Mean age was 43.5 months, half were boys, 10% did not complete the study, and 93% consumed more than 85% of drinks.
76% had complete global hyperactivity aggregate data.
The effect of mix A was significant for increasing global hyperactivity aggregate score (P = .044), whereas mix B did not increase scores.
The effect of mix B was highly variable, with substantial individual differences.
The effect size was 0.20 for mix A.
8- to 9-year-old children (n = 119):
Mean age was 106.3 months, half were boys, 10% did not complete the study, and 75% consumed 85% or more of the drinks during the challenge weeks.
The effects of mixes A and B on global hyperactivity aggregate score were significantly greater than that of placebo for complete case groups (P = .023 and
P = .001, respectively).
The effect size was 0.12 for mix A and 0.17 for mix B.
Pearls for Practice
Consumption of a low-dose mix of artificial food color and additives is associated with increased hyperactivity in 3-year-old children.
Consumption of 2 different doses of artificial food color and additives is associated with increased hyperactivity in 8- to 9-year-old children.
Medscape Medical News 2007. ©2007 Medscape
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