Food Additives Effects on Children With ADHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03342469
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : January 11, 2018
Information provided by (Responsible Party):
Kathleen Holton, American University

Brief Summary:
The purpose of this study is to examine the effects of food additives on children with ADHD. This study could potentially answer an important question which still remains unanswered as to whether certain food additives may be able to cause behavioral changes in children with ADHD. In this context, food additives will be artificial food coloring.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Other: Artificial Food Coloring Other: Placebo Not Applicable

Detailed Description:
Consent and assent will be obtained at the first visit. Baseline data will be collected on the children, including height, weight, hemoglobin levels, computerized cognitive functioning, and an EEG recording. The parent(s) and the child's teacher will be asked to complete a behavioral assessment over the next two days. The parent(s) will also be taught how to keep a detailed food and symptom diary over the following week. One week later, the parent(s) and child will return to the lab and turn in the food/symptom diary. Parent(s) will be trained on how to follow the dietary intervention. Detailed information on the diet will be given, including food additives to avoid, healthy foods which should be eaten, shopping tips and recipes. For the next two weeks, the family will follow the dietary intervention at home with access to Dr. Holton to answer any questions. The parents and child will return to the lab after following the diet for two weeks and assessments (hemoglobin, cognitive testing, and EEG) will be completed again. The parent(s) and teacher will also fill out a post-diet behavioral assessment and information on dietary compliance will be collected. The third meeting will also mark the beginning of the first challenge period. For the challenges, the child will consume chocolate cookies every Monday, Tuesday, and Wednesday for two weeks. The cookies may or may not contain artificial food coloring depending on the week. Every Wednesday repeat testing will be completed after the cookies are consumed. The parents and the child's teacher will fill out a behavioral assessment on Thursday of each week. Children will be asked not to take ADHD medication on testing days. After two weeks of challenges the study will be completed. Parents will receive information on their child's performance and on the study results overall.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will be exposed to all challenge mixtures with adequate washout periods between exposures.
Masking: Double (Participant, Investigator)
Masking Description: The investigators and the participants will be masked as to contents of the chocolate cookies provided during the challenge periods. One research assistant will be unblinded and will not have contact with the participants.
Primary Purpose: Treatment
Official Title: Food Additives Effects on Children With ADHD
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Arm Intervention/treatment
Active Comparator: Artificial Food Colorings Challenge
A high consumer child dose totaling of 225 mg of the six most common artificial food colors (Red 40, Red 3, Yellow 5, Yellow 6, Blue 1, and Blue 2) will be mixed in chocolate cookies and consumed consecutively over three days (Monday, Tuesday, Wednesday). The chocolate will mask the food coloring.
Other: Artificial Food Coloring
Artificial Food Coloring (AFC)
Other Name: AFC

Placebo Comparator: Placebo Challenge
The participants will consume chocolate cookies with no food coloring.
Other: Placebo
Chocolate cookies with no additives

Primary Outcome Measures :
  1. Conners 3-P and 3-T Assessment [ Time Frame: Once a week for 6 weeks ]
    The Conners Assessment quantifies behavioral symptoms. It yields T-scores of 0-100 for the sub-scales of inattention, hyperactivity/impulsivity, learning problems, executive function, aggression, and peer relations. A score of >63 is indicative of ADHD.

  2. Electroencephalogram (EEG) [ Time Frame: Once a week for 6 weeks. ]
    The participants will have small disks placed on their scalp that are connected to electrodes which in turn are connected to a computer. The participants will sit still with their eyes closed while the computer records their brain wave data

  3. Cognitive Testing [ Time Frame: Once a week for 6 weeks ]
    The participant will complete computerized cognitive testing designed for ADHD.

Secondary Outcome Measures :
  1. Nutrient and Food Additive Intake [ Time Frame: 6 weeks ]
    Participants will keep a food log.

  2. Symptom Diary [ Time Frame: 6 weeks ]
    Parents of the participant will keep a symptom diary.

  3. Hemoglobin [ Time Frame: Baseline ]
    A small finger pricked will be completed to test iron levels in the blood.

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Generally good health
  • 8-12 years old
  • Currently attending school
  • Physician's diagnosis of ADHD (unless control participant)
  • Stable medication dose and frequency for 3 months before the study
  • Willing to suspend ADHD medication administration on testing day and the day after testing

Exclusion Criteria:

  • Presence of comorbid psychiatric condition other than comorbid depression or anxiety
  • Autism
  • Severe asthma requiring past hospitalization
  • Seizure disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03342469

Contact: Anna Kirkland (202) 885- 6099

United States, District of Columbia
American University Recruiting
Washington, District of Columbia, United States, 20007
Contact: Anna Kirkland    202-885-6099   
Sponsors and Collaborators
American University
Principal Investigator: Kathleen Holton, PhD American University

Responsible Party: Kathleen Holton, Assistant Professor, American University Identifier: NCT03342469     History of Changes
Other Study ID Numbers: IRB-2017-151
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kathleen Holton, American University:
Food Additives
Artificial Food Coloring

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders