Hand me those dyes and additives,

"Hand Me Those Dyes and Additives, I am Not

Hyper Enough: Relationship of Food

Additives and Dyes in Children"

Sara Mastrine, Chelsea Keady, Rebecca Dean, Erin Shirk, & Brandon King

Presented by: Tuesday, May 14, 2013

Outline• What is Hyperactivity and ADHD?

• Symptoms• Causes• Diagnoses

• Video “Rise in Prescriptions Unnecessary”• Alternatives (Diet)• Artificial Food Dyes/Additives• Current Regulations/News• Formulation of PICO• Databases• Articles• Group Tally Sheets• Group Conclusion/ Summary• Grade• References

What is Hyperactivity & ADHD?

ADHD• Attention Deficit Hyperactivity Disorder• National Institute of Mental Health says 3%-5% of children are

affected with ADHD but some experts suggest number may be as high as 8%-10%.

• Unclear whether children ever actually outgrow ADHD.• Symptoms include:

• Easily distracted• Difficulty following directions or finishing tasks• Forgetful• Often loses things• Squirms, fidgets, unable to sit still• Difficulty playing quietly• Talks excessively• Difficulty taking turns• Often interrupts

• http://www.webmd.com

ADHD (Cont.)-Causes• Causes are not certain.

• Hereditary• Chemical: Possibly due to an imbalance of neurotransmitters

in the brain.• Cigarette or alcohol use during pregnancy.• Exposure to toxins (lead)

• We questioned whether nutrition may play a role..

Hyperactivity & ADHD Diagnoses• “According to National Health Insurance

Corporation’s statistics, the number of adolescents diagnosed with ADHD jumped 2.4 times over the past six years from 18,967 in 2003 to 64,066 in 2009.

• The corporation said 6.5 percent of young people from the ages 6 to 18 have ADHD.

• About 70 percent of patients suffer from the disorder until they reach adulthood, while 30 percent are successfully treated.

• Male children are four more times likely to be affected than females.

• Children with ADHD have difficulty focusing on tasks, controlling their behavior and are hyperactive in ways that are more severe than in average kids.”

Rise in Prescriptions Unnecessary?

• http://www.youtube.com/watch?NR=1&v=ieqO-QCZJ5I&feature=endscreen

http://www.youtube.com/watch?NR=1&v=ieqO-QCZJ5I&feature=endscreen

http://www.youtube.com/watch?NR=1&v=ieqO-QCZJ5I&feature=endscreen

Can Diet Be Used Before Medication? • Insurance companies are looking for ways to make it harder to be

written a prescription for ADHD• Our studies discuss how the diet can affect one’s state of

hyperactivity and ADHD• Observes what can make hyperactivity more severe• Reviews diets that could potentially decrease the number of children

being prescribed medications

Artificial Food Dyes/Additives• What are they?

• Synthetically produced substances added to foods to enhance flavor, appearance, or shelf-life.

• What are they used for?• Taste tests have shown that people enjoyed foods more when

they had a variety of colors.

• What are they added to?• Candy, cakes, sports drinks• Macaroni and cheese, medicines, salad dressing, and canned

fruits

Current Regulations/News• United States is one of the only

countries without regulations on artificial food dyes.

• Countries such as Russia, Peru, Japan, India, etc. penalize companies for adding unnecessary additives.(Harvard.edu)

• In Britain, Nutri Grain bars are colored with natural coloring, but food dyes are used in the United States.(www.cspinet.org)

• There is currently a petition against Kraft Foods to remove artificial colors from macaroni and cheese in the US. Kraft Foods do not contain dyes in any other country.

“A brand can sell the perception of quality even though the product is actually low in quality.” (harvard.edu)

Formulation of PICO Question• Population: Children• Intervention: Restricted diets or treatments of additives • Comparison: Diets containing food dyes and additives• Outcome: Reduce hyperactivity in children; reduce the prevalence

of ADHD medications

PICO question: What is the relationship between consuming food additives and hyperactivity in children?

Databases used• Sara Mastrine

• EbscoHost• Erin Shirk

• Google Scholar• Rebecca Dean

• EbscoHost• Brandon King

• EbscoHost• Chelsea Keady

• MedLine• Google Scholar

Original ArticleSara Mastrine Article 1

• McCann, D., Barrett, A., Cooper, A., Crumpler, D., Dalen, L., Grimshaw, K., & ... Stevenson, J. (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. Lancet, 370(9598), 1560-1567.

• Randomized, double-blinded, placebo-controlled crossover trial

• Purpose was to test whether consumption of artificial food additives and colors affected children’s behavior.


• Inclusion• Children age 3 or children age 8-9 attending schools in Southampton, UK

• Exclusion• Age criteria, allergies, availability to participate (time)

• Recruitment/Participants• 3 year olds:

• 153 (79 males, 74 females)• 137 completed study

• 8/9 year olds: • 144 (75 males, 69 females)• 130 completed study


• Design• Children were given a crossover between two active juice

mixes (A and B) and placebo drink.• 3 year old group:

• Mix A- 20 mg artificial food coloring and 45 mg sodium benzoate• Mix B- 30 mg artificial food coloring and 45 mg sodium benzoate

• 8/9 year old group• Mix A- 24.98 mg artificial food colors and 45 mg sodium benzoate• Mix B- 62.4 mg artificial food colors and 45 mg sodium benzoate

*Sodium benzoate: Chemical preservative commonly found in highly processed foods.

Original Article Sara Mastrine Article 1

• Design (cont.)• Blinding

• Each child was assigned to one of six sequences of placebo, mix A, and mix B.

• Families and researchers masked to challenge assignments.• Juices tested and found to have no differences in looks or taste.• Juices prepared and packaged by administrator and delivered to

homes by masked researchers.


• Design (cont.)• Children were assessed weekly using a Global Hyperactivity

Aggregate (GHA), which included 3 measures to obtain a GHA score. A fourth measure was added for 8/9 year old age group.

• Measures• ADHD rating scale• Weiss-Werry-Peters (WWP) hyperactivity scale• Classroom observation• Conners continuous performance test II (CPTII)


• Measures Explained• ADHD rating scale: Questionnaire filled out by teachers describing

frequency of behaviors such as inattentiveness and hyperactivity.• Weiss-Werry-Peters (WWP) hyperactivity scale: Parents assessed

children’s behavior based on 7 items (switching activities, interrupting or talking too much, wriggling, fiddling with objects or own body, restless, always on the go, and concentration) to obtain a score.

• Classroom observation: Trained observers (psychology graduates) observed children in classroom to assess occurrence of hyperactive behaviors during structured work and independent work.

• Conners continuous performance test II (CPTII): Only used for 8/9 year old group. Tested attention using computerized visual stimuli.


• Statistical Analysis• Two age groups were treated as parallel but independent studies.• Data analyzed using linear mixed-model methods in SPSS.• Tested the affects of Mix A and Mix B against placebo.


• Results

Mix A vs. Placebo GHA Scores

Groups Mix A Placebo P-value/ significance

3 year old group 131 129 P= 0.004 (Significant difference)

8/9 year old group 132 127 P= 0.123 (Not significantly different)


• Results (cont.)

Mix B vs. Placebo GHA Scores

Group Mix B Placebo P-value/ significance

3 year old group 134 129 P=0.093 (Not significantly different)

8/9 year old group 133 127 P=0.012 (Significantly different)


• Conclusion• Authors: The authors concluded that their findings

support the case that food additives increase the occurrence of hyperactive behaviors in children. The study shows that adverse effects are seen not only in children already affected with ADHD or hyperactivity, but in the general population as well.

• This study lends strong support towards our PICO question of whether or not artificial food additives and preservatives lead to hyperactive behaviors in children.

Review ArticleSara Mastrine Article 2

• Stevens, L. J., Kuczek, T., Burgess, J. R., Hurt, E., & Arnold, L. (2011). Dietary Sensitivities and ADHD Symptoms: Thirty-five

Years of Research. Clinical Pediatrics, 50(4), 279-293. doi:10.1177/0009922810384728

• Review of previous studies testing the effects of food additives on hyperactive behaviors and ADHD symptoms in children including Kaiser-Permanente (K-P) Diet studies and Artificial Food Color (AFC) studies.


• Inclusion: Double- blind, placebo-controlled studies• Exclusion: Age criteria• Interventions: cookies, candy bars, beverages, and capsules

containing food dyes compared with placebos.• Data collection methods: parent/teacher rating scales, visual

motor tests, neuropsychological tests


• Kaiser-Permanente (K-P) Diet• Created by Benjamin Feingold in 1973.• Diet completely free of foods containing natural salicylates

(almonds, apples, peppers, coffee, and teas) and all artificial food colors and flavors.

• Review of 5 K-P diet studies led the authors to conclude that a small amount of hyperactive children respond to this diet in such a way that their behavior at home and school is improved.

*salicylates: naturally occurring chemicals in plants that act as a defense against insects and diseases.


• Artificial Food Color (AFC) Studies• Focused exclusively on artificial food colors and their effects on

behavior.• Included dyes such as allura red, brilliant blue, and sunset yellow. • Most of the studies reviewed showed that AFCs resulted in

significant changes in behaviors among children and adolescents.


• Results

Double-blind, Placebo-controlled Studies of AFC and Additives in Children with Behavior Problems

Study Diet Test P-value

Goyette et al exp. 2 Additive Free Parent rating scale P< 0.025

Williams and Cram Modified K-P Parent/teacher rating scale

P<0.005

Swanson and Kinsbourne

K-P diet Learning Task P<0.05

Pollock and Warner Additive Free Parent rating scale P<0.01

Rowe and Rowe Additive Free Parent rating scale P<0.001

Review Article Sara Mastrine Article 2

• Conclusion• Authors: The authors concluded that there is evidence

of a relationship between artificial food dyes and hyperactivity in children. They strongly suggest continuing research in this area.

• This article discusses the results of many studies done on this topic, further showing that there is definitely a strong relationship between artificial food additives and hyperactivity/ADHD in children.

Primary ArticleChelsea Keady (Article 1)

• Boris, N., & Mandel, F. (1994). Foods and additives are common causes of the attention deficit hyperactive disorder in children. Annals of Allergy, 73, p462-466

• Subjects:• All school aged children

• 3 children withdrew from the study• All of the children experimented with both diets, the children

that responded favorably to the elimination diet, then completed a double-blind placebo challenge


• Inclusion:• Children who met the criteria for ADHD• ADHD developed before 7 years of age and has been noticeable

for at least 6 months with certain criteria present• All members had a high score of over 66 on the Conners’ Parent

Rating Scale-48• Exclusion:

• None included


• Intervention:• All of the subjects completed a 2 week elimination diet• After the 2 weeks, the parents completed another CPRS-48 form• Those children who responded favorably to the elimination diet,

then completed two phases of the DBPCFC that were each one week in length


• Results:• 73% of the subjects that completed the first elimination diet

challenge responded favorably• All of these subjects continued to show improvement in their

behavior during the two phase DBPCFC


• Author’s Conclusion:• The DBPCFC study supports the role of dietary factors in ADHD.

Through a simple elimination diet symptoms can be controlled• My Conclusion:• This study shows that the elimination diet is effective in

helping control the symptoms of ADHD• The study was completed in a controlled and well monitored

manner, so I feel that the results are reliable

Review ArticleChelsea Keady (Article 2)

• Schnoll, R., Burshteyn, D., Cea-Aravena, J. (2003.). Nutrition in the treatment of attention-deficit hyperactivity disorder: A neglected but important aspect, 28 (1), 63-66.

• 3 studies included• Subjects:

• Ages ranged from 3-12• All subjects completed the study they were in– no dropouts• All double-blind crossover studies

Review Article Cont.Chelsea Keady (Article 2)

• Inclusion:• All of the studies included children who met the criteria for ADHD

• Exclusion:• None included

Primary Article Cont.Chelsea Keady (Article 2)

• First Study• Intervention:

• Harley et al.–• Each child was maintained on the Feingold diet (elimination diet)

and the control diet for a period of 3 or 4 weeks• The study team provided all foods and dietitians made home

visits to ensure adherence• Parents and teachers rated their behavior


• Results:• Parental ratings found that some of the boys responded favorably

when following the Feingold diet• Teacher ratings, however did not agree with these findings• Significant behavior change was found for the preschool boys—

teacher ratings were not available for this group• All of the 10 mothers found their children to be more

manageable when following the experimental diet


• Second Study• Intervention:

• Conners et al.—• Each child was maintained on the Feingold and control diet for 4

weeks


• Results:• Improvement in behavior was found in 4 out of the 15 children,

but only when the control diet was given first followed by the elimination diet


• Third Study• Intervention:

• Swanson and Kisbourne—• Admitted the children to hospital, so elimination diet could be

administered in a controlled manner• Used a laboratory test of cognitive functioning to assess their

behavior


• Results:• They found that the performance on the laboratory test was

significantly worse after the dye challenge than after the placebo challenge


• Authors’ Conclusion:• These studies suggest that there is a small subset of children who

do demonstrate a dramatic reduction in hyperactive behavior when following the elimination diet.

• Preschool children, as compared to school-age children, may be more sensitive to food dyes, and may respond more favorably to the elimination diet.

• My Conclusion:• I think the studies are all of good quality. All of them were

double-blind the people evaluating the behaviors of the children and the children themselves, did not know what diet they were receiving.

Original ArticleErin Shirk (Article 1)

• Buitelaar, Jan K., Frankena, Klaas, Pelsser, Lidy M.J., Pereira, Rob Rodrigues, Savelkoul, Huub F.J., Toorman, Jan. (March 2008). A randomized controlled trial into the effects of food on ADHD. European Child & Adolescent Psychiatry 18;1, p 12-19

• Randomized controlled trial

• Purpose: To assess the efficacy of a restricted elimination diet in reducing symptoms in an unselected group of children with Attention deficit/hyperactivity disorder (ADHD).

http://web.ebscohost.com.navigator-iup.passhe.edu/ehost/viewarticle?data=dGJyMPPp44rp2/dV0+njisfk5Ie46bFRr6u1TbSk63nn5Kx95uXxjL6nsEe2pbBIr6eeSbCwskm4qbY4zsOkjPDX7Ivf2fKB7eTnfLujt1Czr7NRsae0PurX7H+72+w+4ti7ebfepIzf3btZzJzfhruor0murLVNsZzkh/Dj34y73POE6urjkPIA&hid=11


• Exclusion Criteria: • Adopted or foster

children, co-existing neurological diseases, an IQ below 70, prematurity or dysmaturity, use of alcohol, or smoking by mother during pregnancy

• Co-existence of other psychiatric disorders, except for oppositional defiant disorder (ODD) and conduct disorder (CD)

• Inclusions Criteria:• Dutch children referred to

ADHD Research Center between January and June 2006

• Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) for ADHD Combined Type or Predominantly Hyperactivity-Impulsive Type criteria

11 completed the trial


13 completed trial

1 dropped out: withdrawn

15 assigned to intervention group

2 dropped out:1 child sick1 withdrawn

27 randomized

12 assigned to control group

52 excluded:43 not meeting inclusion criteria9 refused to participate

72 children screened for eligibility


• Initial N: 79 children screened for eligibility• Attrition (final N): 27 randomized; 24 actually completed• Age: Between 3.8 and 8.5 years old (mean age: 6.2)• Ethnicity: Not noted• Other relevant demographics: Children referred to the

ADHD Research Center• Anthropometrics: Not noted• Location: The Netherlands

Original Article: DesignErin Shirk (Article 1)

• Design: 1 test group and 1 control group• Blinding used- Subjects were randomly assigned to one

of the two groups by means of a sequence of numbered cards in sealed unmarked envelopes that were prepared by an independent pediatrician. The envelopes were picked and opened by the parents in the presence of the researcher, and treatment was then dispensed in accordance to the allocation on the card.

• Intervention- Elimination diet – “Few Foods” i.e. Restricted Diet

Original Article: DesignErin Shirk (Article 1)

Measure Points

Rating scales parents

Rating scales teacher

Intervention group

Control group

Week 1 1 Entrance trial

ACS-1, ARS-1 Start of baseline diet

Start of baseline diet

Week 2 Baseline diet Baseline diet

Week 3 2After baseline

ACS-2, ARS-2, SPI

ACS-2, ARS-2 Baseline diet endsElimination diet starts

Baseline diet endsWaiting list starts

Week 4-9 Elimination diet

Waiting list

Week 9 3At endpoint

ACS-3, ARS-3, SPI

ACS-3, ARS-3 Elimination diet ends

Waiting list endsElimination diet starts (if desired)

Original Article: Rating ScalesErin Shirk (Article 1)

• ACS: Abbreviated ten-item Conner’s scale• Consists of ten items of behavior, focusing on overactivity,

impulsitivity, and inattention• Uses a four-point rating scale (0-never, 1-sometimes, 2-often, 3-

always)

• ARS: ADHD Rating Scale• Scores are divided in three parts:

• The number of ADHD criteria (18 in all)• Nine items regarding impulsivity and hyperactivity• Remaining marked out on a four-point rating scale

• SPI: Structured Psychiatric Interview • Secondary endpoints• Parent Ratings on ODD (oppositional defiant disorder) based on

DSM-IV-criteria for ODD.

Original Article: Statistical AnalysisErin Shirk (Article 1)• SPSS version 9.0 was used for all statistical analyses. • Analyzed on an intention-to-treat basis (ITT)

• Intended to avoid various misleading artifacts that can arise in intervention research.

• Effect Size• % Scale Reduction • Cohen’s d – the difference between two means divided by a

standard deviation for the data

• A p-value of <.05 was considered statistically significant • All testing was two-tailed

• Testing whether the treatment results in outcomes that are different than chance, either better or worse

Original Article: Statistical AnalysisErin Shirk (Article 1)

• Subjects were defined as showing clinically significant improvement if the difference between measure point 3 and measure point 2 was 50% or more on both the ACS and the ARS. • Student’s t test – Used to determine if two sets of data

are significantly different from each other• Fisher’s exact test – Used when sample sizes are small;

useful for categorical data to examine the significance of the association between categories

Original Article: ResultsErin Shirk (Article 1)

• Primary Outcomes• No significant difference in the scores of both

measurement points for the ACS or ARS• At the end of the trial, the mean scores of the

intervention group showed a 62.6% improvement on the ACS and 70.3% improvement on the ARS Number of ADHD criteria (P>0.001).• In the waiting list (control group), scores increased by

4.4% (ACS) and decreased by 2.2% (ARS Number of ADHD criteria).

• Difference on the improvements between the intervention group and control group—17.6 (95% Confidence Interval, 12.5-22.6 on the ACS and 9.4% (95% CI 5.9-12.8, p< 0.001) on the ARS Number of ADHD criteria. The control group had no responders.

Original Article: Results Erin Shirk (Article 1)

• The effect size (Cohen’s d) was a 2.8 (67.3% scale reduction) on the ACS and 2.1 (69.4% scale reduction) on the ARS Number of ADHD criteria

• Parent ratings 11/13 children (85%) in the intervention group who completed the study showed an improvement of 50% or more

• Teacher ratings confirmed parent conclusions • 64.3% scale reduction on the ACS• 70.6% scale reduction on ARS Number of ADHD criteria

• Intervention Group – 11/15 (73%) classified as responders• Did not meet the DSM-IV-criteria for ADHD anymore

• Control Group – 0/12

Original Article: Results Erin Shirk (Article 1)

• Secondary Outcomes• ODD (Oppositional Defiant Disorder) • Entrance of trial

• 12/15 children in the intervention group • 10/12 children in the control group

• End of trial• 4/15 children in the intervention group• 10/12 children in the control group

Intervention group’s co-existent ODD-criteria was diminished by 66%.

Original Article: Conclusions Erin Shirk (Article 1)

• Author:• Elimination diet triggers a significant change in both ADHD-

symptoms and ODD-symptoms • The appliance of an elimination diet in young children might

reduce risks of maladjustment • Toxic, pharmacological, or immunologic mechanisms and the

physiological effects of different foods need to be further studied.

Elimination diets could possibly serve ADHD diagnoses as well as they serve food sensitivity diagnoses . Rather than put children on ADHD stimulant medication, elimination diets should be followed. A larger study on the benefits of the elimination diet in children with hyperactivity disorders is needed.

Review Article Erin Shirk (Article 2)

• Schab, David W., Trinh, Nhi-Ha T., (2004). Do Artificial Food Colors Promote Hyperactivity in Children with Hyperactive Syndromes? A Meta-Analysis of Double-Blind Placebo-Controlled Trials. Journal of Developmental and Behavioral Pediatrics. 25 (6); 423-434, 2004

• Purpose: Investigate the significance on the intake of artificial food colors (AFCs) and hyperactivity symptoms in children with hyperactive syndromes.

Review Article Erin Shirk (Article 2)

• Exclusion Criteria:• A trial would be

excluded if its subjects had participated in another included trial.

• Inclusion Criteria:• Randomized and

employment of any of several reversal designs were acceptable

• Trials had to have subjects under 18 years of age and had to meet the ADHD diagnostic criteria.

• Trials had to employ an intervention that could isolate the effects of AFCs.

Review Article Cont.Erin Shirk (Article 2)

• Recruitment: OldMedline, MedLine, PubMed, PsychInfo, Digital Dissertations/UMI ProQuest, ToxLine, Current Contents, Biosis, the Cochrane Controlled Trials Register, and EMBASE

• Blinding used (if applicable): Double-blind placebo-controlled trials

• Intervention: Artificial Food Colors

Review Article: Databases Erin Shirk (Article 2)

• Abstracted data• Graded for validity/bias threats• Segregation• Random effects• Variance for SMD 2(1-r)/n• Imputation & Noncontinuous• Homogeneity tests• Sensitivity tests• Publication bias tests

Review Article Cont.Erin Shirk (Article 2)

• Statistical Methods• DerSimonian and Laird random effects model with the

standardized mean difference for effect size (ES)• Describes the difference in outcome between active and control

arms of a trial in terms of the number of pooled standard deviations by which the two groups differ.

• Mantel-Haenszel test of homogeneity demonstrated that within-group statistical homogeneity was unlikely (p<0.20).

• Funnel plot was created to evaluate the potential for publication bias.

• Fail-safe n for ES represented the number of unpublished studies with an ES of zero (ES of 0.15)

Review Article: ResultsErin Shirk (Article 2)

Review Article: ResultsErin Shirk (Article 2)

Review Article: ConclusionErin Shirk (Article 2)

Author: • Our meta-analysis supports the hypothesis that AFCs promote

hyperactivity in hyperactive children, as measured on behavioral rating scales.

• At the very least, regulators should track consumption of AFCs; we know only that domestic production of food dyes quadrupled between 1955 and 1998

Longitudinal studies should be done to determine the safety of food additives and artificial food dyes. Elimination diets should be utilized in attempting to reduce hyperactivity symptoms

Original ArticleRebecca Dean Article 1

• Connolly, A. A., Boylan, E. E., Flynn, A. A., Gibney, M. J., Hearty, A. A., Nugent, A. A., & McKevitt, A. A. (2010). Pattern of intake of food additives associated with hyperactivity in Irish children and teenagers. Food Additives & Contaminants. Part A, Chemistry, Analysis, Control, Exposure & Risk Assessment, 27 (4), 447-456.

• Double-blinded, randomized-controlled study

• Purpose• To test whether or not there is a relationship between the consumption of

various mixes of seven target additives by children and the onset of hyperactive behavior


• Inclusion Criteria• Children ages 5-12• Teenagers ages 13-17• Irish nationality

• Exclusion Criteria• N/A

• Recruitment• Children (surveyed by the National Children’s Food Survey)

• 594

• Teenagers (surveyed by the National Teen Food Survey)• 441

• Reasons for Withdrawals• N/A


• Design• Adolescents were surveyed (intake diaries) over seven days on quantitative food

intake containing seven different food additives as compared to the previous Southampton study (UK)

• Intake diaries included the day of the week and type of meal (i.e. breakfast), as well as physical activity measurements, lifestyle, and attitude information

• Additives (maximum permitted level)• Sunset Yellow (E110)• Carmoisine (E122)• Tartrazine (E 102)• Ponceau 4R (E124)• Allura Red (E 129)• Quinoline Yellow (E 104)• Sodium Benzoate (E 211)

• Food-Eating Occasions Consumed• Children: 72,024• Teenagers: 46, 473

• Meal-Eating Occasions Recorded• Children: 19,795• Teenagers: 13,541


• Design (cont.)• Importance of Brands

• 36 branded food items• Linked to identification codes according to the Irish National Food

Ingredient Database (INFID)• Listed general information about the food i.e. brand name, product

description, product weight, country of origin, ingredients, and nutritional information


• Statistical Analysis• Irish children and teenagers were tested in comparison to the

previous Southampton study• Food Consumption Data

• Exported from dietary analysis software WISP as food files into SPSS (categorized food groups)

• Creme software conducted exposure assessments• Raw food intake data from the survey diaries• European Union Directive food groups• Occurrence of target additives per food group


• Results• The majority of additive containing food-eating occasions for both

children and teenagers only contained a maximum of one target additive

• Children: 3.8%• Teenagers: 3.1%

• The majority did not contain any of the target additives• Children: 94.8%• Teenagers: 96.2%

• Brands containing at least one target additive• Children: 5.0%• Teenagers: 3.9%

• Unique Brand Codes• Children: 5,551 brand codes• Teenagers: 4,921 brand codes


• Results (cont.)• Children: no food-eating occasion contained five or more of the

target additives• Teenagers: no food-eating occasion contained six or more of the

target additives• The majority of meals for both populations contained at least one

target additive• As the number of foods per meal-eating occasion decreased, the

presence of an additive-containing food increased• Higher occurrence of additives in snack foods


• Results (cont.)• “Fine Bakery Wares” and “Non-Alcoholic Flavored Drinks” food groups contained the

most brands containing target additives for both populations• Many food groups consumed did not contain any of the target additives• Children: consumed 20 of the 36 food groups allowing the target additives• Teenagers: consumed 16 of the 34 food groups allowing the target additives• In all cases, none of the subjects who ever achieved an intake on all seven days at the

levels of the Southampton study• The conservative estimates of intake of food additives in Irish teenagers and children are

below those used in the Southampton study which demonstrated a relationship between food additive intake and hyperactivity in UK children

• The estimated upper intakes for a very small proportion of Irish teenagers and children exceeded the intake levels used in the Southampton study on individual days, but never on seven consecutive days

• When analyzing the food groups permitted to contain the target food additives, it is clear that even though the food additives were permitted in a number of food groups, the children and teenagers only consumed a small proportion of these food groups (approximately half)

• The majority of the brands consumed did not contain any target additives


• Conclusion• Authors’ Conclusion

• In Irish children and teenagers, levels of exposure to food additives rarely, if ever, reach the levels used in the Southampton study

• The consumption of the combination of additives in single foods or in eating occasions of multiple foods hardly ever occurs

• The data suggests that the risk-assessment process that followed from the Southampton study should be reconsidered

• Limitations• Overestimation of food intakes• Age• Sample size• One location/nationality• Low exposure to food additives• Low exposure to combined food additives• Invalid adjustment to energy needs according to age

• My Conclusion• The study does not strongly support the PICO question of whether or not artificial food additives

have an effect on hyperactivity. It states that more research must be conducted in order to have enough supporting evidence. The study was of decent quality. There was a respectably large sample, but it only pertained to one country. Statistics were clear but broad. The non-bias, double-blinded qualities benefitted the study. I would like to see more studies researching other factors related to food additives and the effects on hyperactivity.


• Spring, C., & Perry, L. (1981). Case studies of effects of artificial food colors on hyperactivity. Journal Of Special Education, 15361-372.

• Double-blinded, double-crossover study

• Purpose:• To test Feingold's hypothesis that synthetic food colors cause

hyperactivity in some children• Feingold’s Diet: Controls hyperactivity by eliminating

artificial colors and flavors


Inclusion Criteria• Caucasian• Male• Ages 8-13• Middle-income families (except Subject B, receiving some welfare support)• All on diets effectively restricting artificial food colors and flavors

Exclusion Criteria• N/A

Recruitment• Initial: 8 Caucasian Males• Final: 6 Caucasian Males

Reasons for Withdrawals• Pre-diet hyperactivity ratings were below the 15-point cutoff (initial recruitment)• Taken out of school to begin an early summer vacation with the child’s parents (Subject C)• Serious family problem (Subject F)


Design• Subjects challenged twice, for 3-day periods, with synthetic colors introduced in chocolate

cookies• Contained all artificial colors currently approved by the FDA• 2 cookies/day results in a full challenge equivalent to the average daily dose

• Cookies identical in appearance and taste contained no synthetics on control days• Each cookie contained 13 mg of food colors in the following proportions:

• Red 40 - 38.78%• Yellow 5 - 26.91%• Yellow 6 - 22.74%• Red 3 - 6.08%• Blue 1 - 3.12%• Blue 2 - 1.70%• Orange B - 0.54%• Green 3 - 0.13%


Design (cont.)• 8 week study

• 2 week baseline period• Hyperactivity ratings taken for Tuesday, Wednesday, and Thursday per week

• 6 week experimental period• 2 cookies (one before and after school) eaten on Tuesdays, Wednesdays, and Thursdays

per week• Diet diary by mothers listing all food items and amounts eaten by their child

• Group 1: Challenged during experimental weeks 1 and 4• Group 2: Challenged during experimental weeks 3 and 6• Diet history taken before baseline phase through interviews with mothers• Ratings by mothers of typical behavior before and after the Feingold diet• Ratings of subjects’ attitudes toward the Feingold diet


Design (cont.)• Butylated hydroxytoluene (BHT), naturally occurring salycilates, and white sugar eliminated or

reduced in diets of certain subjects• Artificial colors and flavors

Eliminated from all subjects• BHT

A , B, D – reducedC – eliminatedE , F – N/A

• Natural salycilatesF – reducedB – eliminatedA, C, D, E – N/A

• White sugarA , B, D – reducedC – eliminatedE, F – N/A


Design (cont.)• Hyperactivity ratings before diet

A – 26B – 26C – 27D – 27E – 25F – 23

• Hyperactivity ratings during dietA – 15B – 13C – 12D – 13E – 12F – 14

• Approximate months on dietA – 8B – 7C – 32D – 23E – 32F – 30

• Attitudes towards the Feingold diet (0 = Does not like the diet; 1 = Does not mind the diet)A , B, C, D, & F = 0; E = 1


Design (cont.)• Learning Disabilities

A – R (Reading), Sp (Spelling), AR (Arithmetic)B – R, Sp, ARC – R, Sp, ARD – R, SpE – N/AF – R

• Special ClassesA, B, C, D: YesE, F: No

• MedicationB, C, D, F: YesA, E: No*Subjects C and F discontinued medication before going on the Feingold diet


Statistical Analysis• Abbreviated hyperactivity rating scale

• Ratings obtained by mothers• Responses identical with those used with Conners' 10-item hyperactivity scale

• (0 - not at all, 1 - just a little, 2 - pretty much, 3 - very much)1. Restless or overactive2. Excitable, emotional behavior3. Fails to finish things, short attention span4. Acts without thinking5. Inattentive, easily distracted6. Defiant, difficult to discipline7. Temper outbursts, explosive unpredictable behavior8. Constantly fidgeting9. Demands must be met immediately, easily frustrated10. Problem interacting with other children

• Total hyperactivity ratings computed by adding ratings for each item (0-30 points)


Statistical Analysis• Global Behavior Judgment

• Mothers and teachers responded to behavior on a given day• Guessed whether challenge or control cookies consumed

• Fisher Exact-Probability Tests• Determine how closely the guesses of each subject's mother and teacher

matched actual daily cookie treatments• Low probabilities indicate a close match between guesses and actual

treatments• Point-Biserial Correlations

• Measured hyperactivity for each subject, of daily hyperactivity ratings with daily diet-challenge treatments


Results• Initial 8 subjects

• Correlation b/t mothers' pre-diet hyperactivity ratings and positive neurological signs• 0.81 (p<0.01, one-tailed test)

• Correlation b/t mothers' during-diet hyperactivity ratings and positive neurological signs• 0.51 (not significant)

• Correlation b/t mothers' pre-diet hyperactivity ratings and the composite index• 0.68 (p<0.05, one-tailed test)


Results (cont.)• Global Behavior Judgment

• Mothers’ guesses (correct/incorrect)• Challenge days

A – 4/2B – 2/4C – 2/4D – 0/6E – 3/3F – 1/5

• Control daysA – 9/3B – 8/4C – 5/1D – 9/3E – 10/2F – 5/4

Results (cont.)– Global Behavior Judgment

• Teachers’ guesses (correct/incorrect)

– Challenge daysA – 1/5B – 4/2C – 1/5D – 1/3E – 4/1F – 1/4

– Control daysA – 6/3B – 6/5C – 5/1D – 6/4E – 8/2F – 6/3


Results (cont.)• Fisher Exact-Probability Tests

• Subject E: Mother and his teacher fairly accurate in their guesses; only the teacher's data were significant (p=0.05)

• Subject A: Mother fairly accurate, but not significantly• Data for remaining subjects: Indicated little accuracy, failing to demonstrate the expected

relationship between hyperactivity and food color challenges for these subjects• Point-Biserial Correlations

• Mothers' ratingsA – 51 (p<0.05)B – 0.33C – (-0.07)D – (-0.05)E – 0.55 (p<0.05)F – 0.10

• Teacher’s ratingsA – (-0.08)B – (-37)C – 15D – 0.00E – 65 (p<0.05)F – 0.14


Results (cont.)• Subject E

• Strongest results; mother and teacher were both able to relate diet challenges to episodes of hyperactivity

• Regard the positive relationship between subject E's diet challenges and his behavior as casual• Subject A

• Weakest results; only mother detected the relationship• Mother revealed that during the first challenge week an event occurred at home that strained

relations with his parents for several days• Likely that the positive relationship between subject A's home behavior and the first challenge was

coincidental• Data for the remaining subjects

• Little relationship b/t daily hyperactivity ratings and daily treatments• Subject E

• Lowest infraction rate• Did not mind the diet• Relationship b/t diet challenges and behavior is casual• Failed to replicate the relationship

• High infractions for subjects A, C, and F• Daily diet-challenge treatments redefined• Analyses yielded results that gave less support to Feingold’s hypothesis than original analysis

Original ArticleRebecca Dean Article 2Conclusion

Authors’ Conclusion• Subject E might be responsive to artificial food colors• The challenge-behavior relationship was not duplicated in a subsequent replication

attempt• Cannot conclude that Feingold's hypothesis received obvious support from subject E's

data• Support does not justify the broad claims made for the efficacy of a diet eliminating

artificial food colors• The possibility that a very small percentage of hyperactive children are responsive to

artificial food colors, however, cannot be ruled out• Feingold's hypothesis has not fared well under experimental studyLimitations

-Diet infractions/violations-Inconsistent mothers’ reports of diet effectiveness-Sensitivity to synthetic flavors rather than colors

My Conclusion• The study does not strongly support the PICO question of whether or not artificial food additives have an

effect on hyperactivity. It states that more research must be conducted in order to have enough supporting evidence. The study was of decent quality. Sample size was small, but the non-bias, double-blinded double-crossover qualities benefitted the study. I would like to see more studies researching other factors related to food additives and the effects on hyperactivity.

Primary ArticleBrandon King (Article 1)

• Harley, J., Matthews, C. G., & Eichrnan, P. (1978). Synthetic Food Colors and Hyperactivity in Children: A Double-Blind Challenge Experiment. Pediatrics, 62(6), 975.

• Subjects:• 9 males with an average age of 9 years old• These 9 males were selected from a group of 46 from a previous study that were

most affected by additives and were in the top 50th percentile for hyperactivity of the 46 from the previous study

• None of the subjects withdrew• Double blind challenge experiment


• Inclusion:• All subjects were 9 years old• All average students• None of them had been taking behavioral modification drugs prior to study• Top 50th percentile for hyperactivity from the previous study

• Exclusion:• None stated


• Intervention• The first two weeks the subjects stayed on their regular diet and behavior was

observed• The next two weeks the subjects were put on an elimination diet along with the

rest of their family for the remainder of the study• The subjects were then supplied with a placebo or challenge which came in the

form of candy bars or cookies twice a day with the code kept secret from the observers

• 5 subjects received placebo for a two week period followed by two weeks of challenge, then another two weeks of placebo and ending with three weeks of challenge material

• The other four subjects received the opposite sequence after baseline• The challenge material contained 27mg of food colors and the placebo contained

none


• ResultsPT-Q showed a significant difference of (p>0.001) by mothers, (p>0.001) by fathers, and (p<0.01) by teachers in behavioral ratings, and (p>0.01) by mothers, (p>0.001) by fathers, and (p<0.01) by teachers of the hyperactive group versus the control group. The challenge group showed a significant difference of (p<0.001) by mothers, (p>0.001) by fathers, and (p<0.01) by teachers during placebo conditions as well as challenge conditions, showing symptoms were more severe and significant by the hyperactive group. The "disruptive behavior index" showed a significant difference of (p<0.05) in the first four weeks, but an insignificant difference of (p>0.05) during the placebo and challenge weeks. This shows that the hyperactive group did not show a differential effect.

Primary ArticleBrandon King (Article1)

• Authors conclusion:• The elimination diet or K-P diet has shown evidence supporting that it may

decrease hyperactivity by taking out food coloring but that there is not enough research to say that it is effective.

• My conclusion:• Food coloring and the link between hyperactivity does not have enough evidence

to support it but the elimination diet may help with decreasing hyperactivity in children but more studies need to be conducted.


• Rapp, D. J. (1978). Does Diet Affect Hyperactivity?. Journal Of Learning Disabilities, 11(6),

• Subjects:• 24 children, 6 females and 18 males• 5-16 years in age with a mean age of 10• 7 children withdrew for unknown reasons

• Started with a sublingual dye test, if showed hyperactivity this test was repeated, they then did an elimination diet.


• Inclusion• Short attention spans, easily distractible, impulsive, and had

behavior or learning disabilities and had been recommended for the study by a physician, psychologist, or members of Association for children with learning disabilities

• They are also on a behavior modifying drug or have previously used them unsuccessfully

• Exclusion • No exculsions


• Intervention• Parents completed Abbott Hyperkinesis index sheets before and

at varying intervals throughout study• Children given sublingual dyes to see if any hyperactivity was

observed and if so this was repeated• Subjects were put on an elimination diet for 12 weeks and

observed by parents


• Results• 12 of 23 showed improvement in activity in the first week• 11 of 17 continued to show improvement throughout the study• The subjects that completed all 12 weeks scored a decrease

mean of 11.5 points on the Abbotts Hyperkinesis index sheet


• Authors conclusion:• There is a relationship between hyperactivity and food additives

and allergies but further study needs to be done. • My conclusion:

• There is evidence that supports hyperactivity and a relationship with food coloring but further testing needs to be done on a larger group.

Tally SheetsStudent Name Sara Mastrine Chelsea Keady Rebecca Dean Rebecca Dean Erin Shirk Brandon

KingBrandon King

Author McCann, Donna, et al

Boris, M., Mandel, F.

Connolly, A. A., et al

Spring, C., & Perry, L.

Buitelaar, Jan K., et al

Rapp, B,J Preston, H et al

Year 2007 1994 2010 1981 2008 1978 1978Relevance Questions

1 Yes Yes Yes Yes Yes Yes Yes2 Yes Yes Yes Yes Yes Yes Yes3 Yes Yes Yes Yes Yes Yes Yes4 Yes Yes Yes Yes Yes Yes YesValidity Questions

1 Yes Unclear Yes Yes Yes Yes Yes2 Yes Unclear Yes Yes Yes Yes Yes3 Yes No Yes Yes Yes Yes Yes4 Yes No No Yes Yes No No5 Yes No Yes Yes Unclear Yes Yes6 Yes Yes Yes Yes Yes Yes Yes7 Yes Yes Yes Yes Yes Yes Yes8 Yes Yes Yes Yes Yes Yes Yes9 Yes Yes Yes Yes Yes Yes Yes10 Yes Unclear Yes Yes Yes Yes YesQuality Rating(+, 0, -)

+ + + + + +

Tally Sheet of Quality Ratings: Primary Research

Group Tally Sheet (review)Student Name Sara Mastrine Chelsea Keady Erin ShirkAuthor Stevens, Laura J. et al Schnoll, R., Dmitry, B.,

Cea-Aravena, J.Schab, David W. & Trinh, Nhi-Ha T.

Year 2011 2003 2004Relevance Questions

1 Yes Yes Yes2 Yes Yes Yes3 Yes Yes Yes4 Yes Yes YesValidity Questions 1 Yes Yes Yes2 No Yes Yes3 Yes Unclear Yes4 Unclear Yes Yes5 Yes Yes Yes6 Yes Yes Yes7 Yes Yes Yes8 Yes Yes Yes9 Yes Yes Yes10 Yes Yes UnclearQuality Rating(+, 0, -)

+ + +

Tally Sheet of Quality Ratings: Review Articles

Group Conclusion/ Summary• In our group’s opinion, our articles conclude that in general,

consumption of various Artificial Food Colors (AFCs), food dyes, and other food additives do show increases in hyperactivity in children who meet the DSM-IV criteria for ADHD prior to the ingestion of these additives. Eliminations diets or alternative diet therapies that reduce the consumption of these ingredients have shown to improve behaviors and decrease hyperactivity in children that meet the DSM-IV criteria for ADHD. Therefore, these should be considered when approaching alternatives to traditional ADHD medications in hopes of decreasing the amount of children having these prescriptions written for them.

Grade• Grade II: Fair

• We felt our articles and research provided fair evidence that supported the conclusions of the authors. Our uncertainty attached to the conclusion was due to generally small sample sizes that were not very long in terms of the length of time these studies were being conducted for. Despite these uncertainties, all of our articles suggest that further research would only add to the positive results that were published.

• Withdrawals• Inadequate sample sizes• Blinding discrepancies• Testing on children

References• McCann, D., Barrett, A., Cooper, A., Crumpler, D., Dalen, L., Grimshaw, K., & ... Stevenson, J. (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. Lancet, 370(9598), 1560-1567.

• Stevens, L. J., Kuczek, T., Burgess, J. R., Hurt, E., & Arnold, L. (2011). Dietary Sensitivities and ADHD Symptoms: Thirty-five Years of Research. Clinical Pediatrics, 50(4), 279-293. doi:10.1177/0009922810384728

• http://www.webmd.com/add-adhd/guide/attention-deficit-hyperactivity-disorder-adhd• Boris, N., & Mandel, F. (1994). Foods and additives are common causes of the attention deficit hyperactive

disorder in children. Annals of Allergy, 73, p462-466• Schnoll, R., Burshteyn, D., Cea-Aravena, J. (2003.). Nutrition in the treatment of attention-deficit hyperactivity

disorder: A neglected but important aspect, 28 (1), 63-66.• Connolly, A. A., Boylan, E. E., Flynn, A. A., Gibney, M. J., Hearty, A. A., Nugent, A. A., & McKevitt, A. A. (2010).

Pattern of intake of food additives associated with hyperactivity in Irish children and teenagers. Food Additives & Contaminants. Part A, Chemistry, Analysis, Control, Exposure & Risk Assessment, 27 (4), 447-456.

• Spring, C., & Perry, L. (1981). Case studies of effects of artificial food colors on hyperactivity. Journal of Special Education, 15 361-372.

• 2003. Food Labeling Regulations: A Historical and Comparative Survey . (ONLINE) Available at http://nrs .harvard.edu/urn-3:HUL. (Last Accessed May 11, 2013).

• http://www.cspinet.org/fooddyes/• Buitelaar, Jan K., Frankena, Klaas, Pelsser, Lidy M.J., Pereira, Rob Rodrigues, Savelkoul, Huub F.J., Toorman, Jan.

(March 2008). A randomized controlled trial into the effects of food on ADHD. European Child & Adolescent Psychiatry 18;1, p 12-19

• Schab, David W., Trinh, Nhi-Ha T., (2004). Do Artificial Food Colors Promote Hyperactivity in Children with Hyperactive Syndromes? A Meta-Analysis of Double-Blind Placebo-Controlled Trials. Journal of Developmental and Behavioral Pediatrics. 25 (6); 423-434, 2004

• Harley, J., Matthews, C. G., & Eichrnan, P. (1978). Synthetic Food Colors and Hyperactivity in Children: A Double-Blind Challenge Experiment. Pediatrics, 62(6), 975.

• Rapp, D. J. (1978). Does Diet Affect Hyperactivity?. Journal Of Learning Disabilities, 11(6),

http://www.webmd.com/add-adhd/guide/attention-deficit-hyperactivity-disorder-adhd

http://www.webmd.com/add-adhd/guide/attention-deficit-hyperactivity-disorder-adhd

http://web.ebscohost.com.navigator-iup.passhe.edu/ehost/viewarticle?data=dGJyMPPp44rp2/dV0+njisfk5Ie46bFRr6u1TbSk63nn5Kx95uXxjL6nsEe2pbBIr6eeSbCwskm4qbY4zsOkjPDX7Ivf2fKB7eTnfLujt1Czr7NRsae0PurX7H+72+w+4ti7ebfepIzf3btZzJzfhruor0murLVNsZzkh/Dj34y73POE6urjkPIA&hid=11

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Hand me those dyes and additives,