Food Additives Effects on EEG Profiles in College Students With ADHD

The purpose of this study is to examine the effects of food additives on college students 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 cognitive and electrical activity changes in college students with and without ADHD. In this context, food additives will be artificial food coloring.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Other: Artificial Food Coloring; Other: Placebo

Detailed Description

Consent will be obtained at the first visit. Baseline data will be collected on the participants, including height, weight, computerized cognitive functioning, and an EEG recording. Participants will also be taught how to keep a detailed food and symptom diary over the following week. One week later, the participant will return to the lab and turn in the food/symptom diary. All ADHD participants and a subgroup of controls (called extended controls or EC) 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, and shopping tips. For the next two weeks, the participant will follow the dietary intervention at home with access to Dr. Holton to answer any questions. The participant will return to the lab after following the diet for two weeks and assessments (cognitive testing, and EEG) will be completed again along information on dietary compliance will be collected. The third meeting will also mark the beginning of the first challenge period. For the challenges, the participant 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 participant will be asked not to take ADHD medication on testing days. After two weeks of challenges the study will be completed. The participant will receive information on their performance and on the study results overall.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • American University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Generally good health
• 18-24 years old
• Currently attending college
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADHD- Artificial food coloring, then placebo; Participants first received 225 mg of the six most common artificial food colors (Red 40, Red 3, Yellow 5, Yellow 6, Blue 1, and Blue 2) mixed in chocolate cookies and consumed consecutively over three days (Monday, Tuesday, Wednesday). After a 4-day washout period, they then received placebo of chocolate cookies and consumed them over three days.	Other: Artificial Food Coloring; 225mg mixed powdered Artificial Food Coloring (AFC); Other: Placebo; Placebo chocolate cookies
Experimental: ADHD - Placebo, then artificial food coloring; Participants first received placebo of chocolate cookies and consumed them over three days. After a 4-day washout period, they then received 225 mg of the six most common artificial food colors (Red 40, Red 3, Yellow 5, Yellow 6, Blue 1, and Blue 2) mixed in chocolate cookies and consumed consecutively over three days (Monday, Tuesday, Wednesday).	Other: Artificial Food Coloring; 225mg mixed powdered Artificial Food Coloring (AFC); Other: Placebo; Placebo chocolate cookies
Experimental: Controls- Artificial food coloring, then placebo; Participants first received 225 mg of the six most common artificial food colors (Red 40, Red 3, Yellow 5, Yellow 6, Blue 1, and Blue 2) mixed in chocolate cookies and consumed consecutively over three days (Monday, Tuesday, Wednesday). After a 4-day washout period, they then received placebo of chocolate cookies and consumed them over three days.	Other: Artificial Food Coloring; 225mg mixed powdered Artificial Food Coloring (AFC); Other: Placebo; Placebo chocolate cookies
Experimental: Controls - Placebo, then artificial food coloring; Participants first received placebo of chocolate cookies and consumed them over three days. After a 4-day washout period, they then received 225 mg of the six most common artificial food colors (Red 40, Red 3, Yellow 5, Yellow 6, Blue 1, and Blue 2) mixed in chocolate cookies and consumed consecutively over three days (Monday, Tuesday, Wednesday).	Other: Artificial Food Coloring; 225mg mixed powdered Artificial Food Coloring (AFC); Other: Placebo; Placebo chocolate cookies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups	Electroencephalography (EEG) is an objective measure of brainwave activity that non-invasively records the electrocortical activity emitted from neuronal postsynaptic outputs using small electrodes placed on the head. Quantitative EEG uses techniques to transform electrocortical voltage amplitudes into frequency bands to reflect mental processes in periodicities instead of raw values. These frequency bands can then be compared before/after treatment and/or between groups to better understand how treatment impacts the brain. Resting-state EEG was collected with eyes-closed, but awake, for four minutes Frequency bands assessed: delta 1-4Hz, theta 4-7Hz, alpha 8-13Hz, beta 13-30Hz, gamma 30-50Hz Each frequency band was assessed using: mean power (microvolts^2 of a frequency band divided by the length of the frequency band) a	Collected after three days exposure to AFC (on third day) and after three day exposure to placebo (on third day)
Relative Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups	Electroencephalography (EEG) is an objective measure of brainwave activity that non-invasively records the electrocortical activity emitted from neuronal postsynaptic outputs using small electrodes placed on the head. Quantitative EEG uses techniques to transform electrocortical voltage amplitudes into frequency bands to reflect mental processes in periodicities instead of raw values. These frequency bands can then be compared before/after treatment and/or between groups to better understand how treatment impacts the brain. Resting-state EEG was collected with eyes-closed, but awake, for four minutes Frequency bands assessed: delta 1-4Hz, theta 4-7Hz, alpha 8-13Hz, beta 13-30Hz, gamma 30-50Hz Each frequency band was assessed using: relative power (sum of microvolts^2 of a frequency band divided by total power to get a percent)	Collected after three days exposure to AFC (on third day) and after three day exposure to placebo (on third day)
ADHD Symptoms During AFC and Placebo Challenge in ADHD and Control Groups	Name: Adult ADHD Self-Report Scale-V1.1 Construct: Self-report checklist of adult ADHD symptoms to screen for possibility of ADHD. It is not meant to be diagnostic. According to the documentation, "The questions in the ASRS v1.1 are consistent with DSM-IV criteria and address the manifestations of ADHD symptoms in adults." Total Range: 0-72 points - higher score indicates more and/or higher frequency of adult ADHD symptoms Sub-scores: Inattentive: sum of number/frequency of nine questions (taken from full ASRS questionnaire) related to inattention Range: 0-36 - higher score indicates more and/or higher frequency of inattention symptoms; Hyperactive: sum of number/frequency of nine questions (taken from full ASRS questionnaire) related to hyperactivity Range: 0-36 - higher score indicates more and/or higher frequency of hyperactivity symptoms	Collected after three days exposure to AFC (on third day) and after three day exposure to placebo (on third day)

Collaborators and Investigators

• Sponsor: American University
• Investigators: Principal Investigator: Kathleen Holton, PhD, American University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): October 15, 2018
• Study Completion (Actual): October 15, 2018

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: November 13, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): September 24, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: ADHD; Diet; Food Additives; Artificial Food Coloring
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: IRB-2017-151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No