1. "Hand Me Those Dyes
and Additives, I am Not
Hyper Enough:
Relationship of Food
Additives and Dyes in
Children"
Presented by:
Tuesday, May 14, 2013
Sara Mastrine, Chelsea Keady, Rebecca Dean, Erin Shirk, & Brandon King

2. 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

3. What is Hyperactivity & ADHD?

4. 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

5. 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..

6. 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.”

7. Rise in Prescriptions Unnecessary?
• http://www.youtube.com/watch?NR=1&v=ieqOQCZJ5I&feature=endscreen

8. 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

9. 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

10. 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)

11. 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?

12. Databases used
• Sara Mastrine
• EbscoHost
• Erin Shirk
• Google Scholar
• Rebecca Dean
• EbscoHost
• Brandon King
• EbscoHost
• Chelsea Keady
• MedLine
• Google Scholar

13. Original Article
Sara 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, placebocontrolled 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.

14. Original Article
Sara Mastrine Article 1
• 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

15. Original Article
Sara Mastrine Article 1
• 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.

16. 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.

17. Original Article
Sara Mastrine Article 1
• 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)

18. Original Article
Sara Mastrine Article 1
• 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.

19. Original Article
Sara Mastrine Article 1
• 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.

20. Original Article
Sara Mastrine Article 1
• 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)

21. Original Article
Sara Mastrine Article 1
• 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)

22. Original Article
Sara Mastrine Article 1
• 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.

23. Review Article
Sara 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.

24. Review Article
Sara Mastrine Article 2
• 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

25. Review Article
Sara Mastrine Article 2
• 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.

26. Review Article
Sara Mastrine Article 2
• 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.

27. Review Article
Sara Mastrine Article 2
• 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

28. 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.

29. Primary Article
Chelsea 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

30. Primary Article
Chelsea Keady (Article 1)
• 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

31. Primary Article
Chelsea Keady (Article 1)
• 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

32. Primary Article
Chelsea Keady (Article 1)
• 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

33. Primary Article
Chelsea Keady (Article 1)
• 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

34. Review Article
Chelsea 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

35. Review Article Cont.
Chelsea Keady (Article 2)
• Inclusion:
• All of the studies included children who met the criteria for ADHD
• Exclusion:
• None included

36. 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

37. Review Article Cont.
Chelsea Keady (Article 2)
• 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

38. Review Article Cont.
Chelsea Keady (Article 2)
• Second Study
• Intervention:
• Conners et al.—
• Each child was maintained on the Feingold and control diet for 4
weeks

39. Review Article Cont.
Chelsea Keady (Article 2)
• 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

40. Review Article Cont.
Chelsea Keady (Article 2)
• 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

41. Review Article Cont.
Chelsea Keady (Article 2)
• Results:
• They found that the performance on the laboratory test was
significantly worse after the dye challenge than after the placebo
challenge

42. Review Article Cont.
Chelsea Keady (Article 2)
• 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.

43. Original Article
Erin 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 1219
• 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).

44. Original Article
Erin Shirk (Article 1)
• 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

45. Original Article
Erin Shirk (Article 1)
72 children screened
for eligibility
52 excluded:
43 not meeting
inclusion criteria
9 refused to participate
27 randomized
15 assigned to
intervention group
12 assigned to
control group
2 dropped out:
1 child sick
1 withdrawn
1 dropped out:
withdrawn
13 completed trial
11 completed the
trial

46. Original Article
Erin Shirk (Article 1)
•
•
•
•
•
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

47. Original Article: Design
Erin 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

48. Original Article: Design
Erin Shirk (Article 1)
Measure
Points
Week 1
Rating scales Rating scales
parents
teacher
Intervention Control
group
group
1
Entrance trial
ACS-1, ARS-1
Start of
Start of
baseline diet baseline diet
Week 2
Week 3
Baseline diet Baseline diet
2
ACS-2, ARSAfter baseline 2, SPI
ACS-2, ARS-2
Week 9
3
At endpoint
ACS-3, ARS3, SPI
ACS-3, ARS-3
Baseline diet
ends
Waiting list
starts
Elimination
diet
Week 4-9
Baseline diet
ends
Elimination
diet starts
Waiting list
Elimination
diet ends
Waiting list
ends
Elimination
diet starts (if
desired)

49. Original Article: Rating Scales
Erin 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, 3always)
• 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.

50. Original Article: Statistical
Analysis
Erin 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

51. Original Article: Statistical
Analysis
Erin 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

52. Original Article: Results
Erin 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.

53. 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

54. 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%.

55. Original Article: Conclusions
Erin Shirk (Article 1)
• Author:
• Elimination diet triggers a significant change in both ADHDsymptoms 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.

56. 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 PlaceboControlled 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.

57. 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.

58. 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

59. 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

60. 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 withingroup 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)

61. Review Article: Results
Erin Shirk (Article 2)

62. Review Article: Results
Erin Shirk (Article 2)

63. Review Article: Conclusion
Erin 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

64. Original Article
Rebecca 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

65. Original Article
Rebecca Dean Article 1
• 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

66. Original Article
Rebecca Dean Article 1
• 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

67. Original Article
Rebecca Dean Article 1
• 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

68. Original Article
Rebecca Dean Article 1
• 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

69. Original Article
Rebecca Dean Article 1
• 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

70. Original Article
Rebecca Dean Article 1
• 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

71. Original Article
Rebecca Dean Article 1
• 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

72. Original Article
Rebecca Dean Article 1
• 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.

73. Original Article
Rebecca Dean Article 2
• 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

74. Original Article
Rebecca Dean Article 2
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)

75. Original Article
Rebecca Dean Article 2
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%

76. Original Article
Rebecca Dean Article 2
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

77. Original Article
Rebecca Dean Article 2
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 – reduced
C – eliminated
E , F – N/A
• Natural salycilates
F – reduced
B – eliminated
A, C, D, E – N/A
• White sugar
A , B, D – reduced
C – eliminated
E, F – N/A

78. Original Article
Rebecca Dean Article 2
Design (cont.)
•
•
•
•
Hyperactivity ratings before diet
A – 26
B – 26
C – 27
D – 27
E – 25
F – 23
Hyperactivity ratings during diet
A – 15
B – 13
C – 12
D – 13
E – 12
F – 14
Approximate months on diet
A–8
B–7
C – 32
D – 23
E – 32
F – 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

79. Original Article
Rebecca Dean Article 2
Design (cont.)
• Learning Disabilities
A – R (Reading), Sp (Spelling), AR (Arithmetic)
B – R, Sp, AR
C – R, Sp, AR
D – R, Sp
E – N/A
F–R
• Special Classes
A, B, C, D: Yes
E, F: No
• Medication
B, C, D, F: Yes
A, E: No
*Subjects C and F discontinued medication before going on the Feingold diet

80. Original Article
Rebecca Dean Article 2
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 overactive
2. Excitable, emotional behavior
3. Fails to finish things, short attention span
4. Acts without thinking
5. Inattentive, easily distracted
6. Defiant, difficult to discipline
7. Temper outbursts, explosive unpredictable behavior
8. Constantly fidgeting
9. Demands must be met immediately, easily frustrated
10. Problem interacting with other children
• Total hyperactivity ratings computed by adding ratings for each item (0-30
points)

81. Original Article
Rebecca Dean Article 2
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

82. Original Article
Rebecca Dean Article 2
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)

83. Original Article
Rebecca Dean Article 2
Results (cont.)
• Global Behavior Judgment
• Mothers’ guesses
(correct/incorrect)
• Challenge days
A – 4/2
B – 2/4
C – 2/4
D – 0/6
E – 3/3
F – 1/5
• Control days
A – 9/3
B – 8/4
C – 5/1
D – 9/3
E – 10/2
F – 5/4
Results (cont.)
–
Global Behavior Judgment
• Teachers’ guesses
(correct/incorrect)
– Challenge days
A – 1/5
B – 4/2
C – 1/5
D – 1/3
E – 4/1
F – 1/4
– Control days
A – 6/3
B – 6/5
C – 5/1
D – 6/4
E – 8/2
F – 6/3

84. Original Article
Rebecca Dean Article 2
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' ratings
A – 51 (p<0.05)
B – 0.33
C – (-0.07)
D – (-0.05)
E – 0.55 (p<0.05)
F – 0.10
Teacher’s ratings
A – (-0.08)
B – (-37)
C – 15
D – 0.00
E – 65 (p<0.05)
F – 0.14

85. Original Article
Rebecca Dean Article 2
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

86. Original Article
Rebecca Dean Article 2
Conclusion
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 study
Limitations
-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, doubleblinded 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.

87. Primary Article
Brandon 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

88. Primary Article
Brandon King (Article 1)
• 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

89. Primary Article
Brandon King (Article 1)
• 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

90. Primary Article
Brandon King (Article 1)
• Results
PT-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

91. Primary Article
Brandon 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.

92. Primary Article
Brandon King (Article 2)
• 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.

93. Primary Article
Brandon King (Article 2)
• 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

94. Primary Article
Brandon King (Article 2)
• 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

95. Primary Article
Brandon King (Article 2)
• 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

96. Primary Article
Brandon King (Article 2)
• 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.

97. Tally Sheets
Tally Sheet of Quality Ratings: Primary Research
Student Name
Sara Mastrine
Chelsea Keady
Rebecca Dean
Rebecca Dean
Erin Shirk
Author
McCann,
Donna, et al
2007
Boris, M.,
Mandel, F.
1994
Connolly, A. A.,
et al
2010
Spring, C., &
Perry, L.
1981
Buitelaar, Jan
K., et al
2008
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
+
Unclear
Unclear
No
No
No
Yes
Yes
Yes
Yes
Unclear
Yes
Yes
Yes
No
Yes
Yes
Yes
Yes
Yes
Yes
+
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
+
Year
Relevance
Questions
1
2
3
4
Brandon
King
Rapp, B,J
1978
Brandon
King
Preston, H
et al
1978
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Unclear
Yes
Yes
Yes
Yes
Yes
+
Yes
Yes
Yes
No
Yes
Yes
Yes
Yes
Yes
Yes
+
Yes
Yes
Yes
No
Yes
Yes
Yes
Yes
Yes
Yes
+
Validity Questions
1
2
3
4
5
6
7
8
9
10
Quality Rating
(+, 0, -)

98. Group Tally Sheet (review)
Tally Sheet of Quality Ratings: Review Articles
Student Name
Author
Sara Mastrine
Stevens, Laura J. et al
Chelsea Keady
Schnoll, R., Dmitry, B.,
Cea-Aravena, J.
Year
Relevance Questions
2011
2003
Erin Shirk
Schab, David W. & Trinh,
Nhi-Ha T.
2004
1
2
3
4
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
Unclear
Yes
Yes
Yes
Yes
Yes
Yes
+
Yes
Yes
Unclear
Yes
Yes
Yes
Yes
Yes
Yes
Yes
+
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Unclear
+
Validity Questions
1
2
3
4
5
6
7
8
9
10
Quality Rating
(+, 0, -)

99. 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.

100. 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

101. 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 DoubleBlind Challenge Experiment. Pediatrics, 62(6), 975.
Rapp, D. J. (1978). Does Diet Affect Hyperactivity?. Journal Of Learning Disabilities, 11(6),

102. Thanks for watching!
Any Questions?