Food Additives Effects on EEG Profiles in College Students With ADHD

NCT03342469 | Completed Results

• 1 other identifier: IRB-2017-151
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Food Additives; Artificial Food Coloring; Diet

Outcome Measures

Primary Outcomes (3)

• 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: 1. 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 2. 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)

Study Arms (4)

ADHD- Artificial food coloring, then placebo

EXPERIMENTAL

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; Other: Placebo

ADHD - Placebo, then artificial food coloring

EXPERIMENTAL

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; Other: Placebo

Controls- Artificial food coloring, then placebo

EXPERIMENTAL

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; Other: Placebo

Controls - Placebo, then artificial food coloring

EXPERIMENTAL

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; Other: Placebo

Interventions

Artificial Food Coloring OTHER

225mg mixed powdered Artificial Food Coloring (AFC)

ADHD - Placebo, then artificial food coloring; ADHD- Artificial food coloring, then placebo; Controls - Placebo, then artificial food coloring; Controls- Artificial food coloring, then placebo

Placebo OTHER

Placebo chocolate cookies

ADHD - Placebo, then artificial food coloring; ADHD- Artificial food coloring, then placebo; Controls - Placebo, then artificial food coloring; Controls- Artificial food coloring, then placebo

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Generally good health
• 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

You may not qualify if:

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

Sponsors & Collaborators

• American University: lead

Study Sites (1)

American University

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

This pilot study had a small sample size, and was not powered to correct for multiple comparisons. The control group had imperfect randomization of challenge materials (AFC/placebo=3, placebo/AFC=8). Dietary compliance was only measured once.

Results Point of Contact

• Title: Dr. Kathleen Holton
• Organization: American University

holton@american.edu

(202) 885-3797

Study Officials

• Kathleen Holton, PhD

  American University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All ADHD participants and a subgroup of control participants will be exposed to all challenge mixtures (artificial food coloring/placebo, placebo/artificial food coloring) with adequate washout periods between exposures.

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 17, 2017
• Study Start: January 1, 2018
• Primary Completion: October 15, 2018
• Study Completion: October 15, 2018
• Last Updated: September 24, 2020
• Results First Posted: September 24, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)