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Old 09-25-2007, 10:32 AM   #1 (permalink)
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Default Food Additives Trigger ADHD in Clinical Trial

Article from Vital Choices Newsletter () September 24, 2007
Food Additives Trigger ADHD in Clinical Trial
Clinical trial links attention deficit/hyperactivity behaviors to blend of artificial food preservative and colors
by Craig Weatherby

Attention deficit hyperactivity disorder (ADHD) can take quite a toll on kids, caregivers, and teachers.

And the widespread prescription of stimulant-type ADHD drugs like Ritalin for children, whose brains are still forming, makes many parents and resarchers nervous.


So parents’ ears prick up at the hint of anything that might alleviate ADHD without resort to controversial pharmaceuticals.

We’ve reported on research indicating that omega-3s may help some children with ADHD.

A new study suggests that there may be substance to some parents’ claims that their kids’ ADHD is triggered or exacerbated by food additives.

Key Points
  • Controlled clinical trial yields rare evidence that additives may cause attention deficits and hyperactivity in kids.
  • Study could not pinpoint which additives were responsible, because they were mixed together.
  • Chemicals tested included artificial food colors and a common preservative.

While it is widely held, the belief that food additives promote attention-hyperactivity deficits in children is scientifically controversial. As the authors of two recent evidence reviews said:
  • “… to date, there is little empirical evidence supporting the effectiveness of dietary restrictions in treating … attention deficit hyperactivity disorder (ADHD).” (Cormier E, Elder JH 2007)
  • “… a critical review of the literature provides very limited support for such a relationship [between food additives and ADHD].” (Cruz NV, Bahna SL 2006)
But the results of a very credible new clinical trial lend weight to parents' concerns about synthetic chemicals in foods.

New results find fault with common additives
Scientists at University of Southampton in England conducted a well-designed clinical trial – randomized, double-blind, placebo-controlled, crossover – intended to test whether intake of artificial food color and additives (AFCA) would affect children’s behavior.


They enrolled 153 three-year-olds and 144 children aged eight to nine years of age, separated them into three groups, and gave each group a different drink:

  • Test Drink A with sodium benzoate (preservative) and artificial food color mix A.
  • Test Drink B with sodium benzoate (preservative) and artificial food color mix B.
  • Placebo drink free of artificial additives and preservatives.
Each group consumed their beverage daily for six weeks. The researchers estimated that the test drink groups ingested artificial additives and preservatives in daily amounts roughly equal to those found in two standard candy bars.

In addition to a computer test, the children were evaluated by parents and/or teachers who were unaware of which drinks the children had consumed.

The researchers found that children of all ages who consumed Test Drink A were significantly more hyperactive and that they had shorter attention spans, compared with the placebo drink groups.

No behavior differences were found between the placebo group and Test Drink B group.

The authors came to this conclusion: “Artificial colors or a sodium benzoate preservative (or both) in the diet result in increased hyperactivity in 3-year-old and 8/9-year-old children ...”

Since all the children received a mix of additives, the authors could not say which of the additives caused problems, but they plan to conduct further trials to pinpoint the problematic compounds.


Sources
  • 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 Sep 5; [Epub ahead of print]
  • Cormier E, Elder JH. Diet and child behavior problems: fact or fiction? Pediatr Nurs. 2007 Mar-Apr;33(2):138-43. Review.
  • Cruz NV, Bahna SL. Do food or additives cause behavior disorders? Pediatr Ann. 2006 Oct;35(10):744-5, 748-54. Review.
Published by Vital Choice Seafood
Copyright © 2007 Vital Choice Seafood, Inc.. All rights reserved.
Information in this newsletter is not meant to substitute for the advice provided by medical professionals, nor is it intended to diagnose, treat, cure or prevent disease. Copyright is held by Vital Choice Seafood, to which all rights are reserved. Other than personal, non-commercial use or forwarding, no material in this newsletter may be copied, distributed, or published without the express permission of Vital Choice Seafood.

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Old 09-25-2007, 11:44 AM   #2 (permalink)
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What do they have against sodium benzoate? It's in A and B. B does nothing and they still say it's part of the problem? Why don't they say that the water in the drink was part of the problem?

I'll bet there's something to the whole additive thing, but why would you leave a hole that big to jump through?
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Old 09-25-2007, 01:44 PM   #3 (permalink)
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If sodium Benozate was the problem, I think you would see a reaction in both groups. and not just group A.

Roland is right, that would be a really big hole in a study. I think it'll help them narrow down what additives might be causing the problems, but without seeing the whole text of the study, you can't really say what they were looking at.
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Old 09-25-2007, 04:11 PM   #4 (permalink)
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“Artificial colors or a sodium benzoate preservative (or both) in the diet result in increased hyperactivity in 3-year-old and 8/9-year-old children ...”

I'm guessing the food color was the key. In searching "
artificial food color mix A" with "ADHD" the following article came up (which I don't have time to read right now!) SOURCE



Artificial Food Additives May Increase Hyperactivity in Children CME/CE

News Author: Laurie Barclay, MD
CME Author: Désirée Lie, MD, MSEd

Disclosures
Release Date: September 10, 2007; Valid for credit through September 10, 2008 Credits Available
Physicians - maximum of 0.25 AMA PRA Category 1 Credit(s) for physicians;
Family Physicians - up to 0.25 AAFP Prescribed credit(s) for physicians;
Nurses - 0.25 nursing contact hours (None of these credits is in the area of pharmacology)

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


Legal Disclaimer

The material presented here does not necessarily reflect the views of Medscape or companies that support educational programming on www.medscape.com. These materials may discuss therapeutic products that have not been approved by the US Food and Drug Administration and off-label uses of approved products. A qualified healthcare professional should be consulted before using any therapeutic product discussed. Readers should verify all information and data before treating patients or employing any therapies described in this educational activity.

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