Attention Deficit Hyperactivity DisorderNCT03342469

Food Additives Effects on EEG Profiles in College Students With ADHD

A study testing Artificial Food Coloring in people with Attention Deficit Hyperactivity Disorder, run by American University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 24 yearsHealthy volunteers can take part
Conditions the study is for: Attention Deficit Hyperactivity Disorder
What is being tested?: Artificial Food Coloring
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 29 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2018to 15 Oct 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 24 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

American University
Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Read the 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.

Conditions: Attention Deficit Hyperactivity Disorder
Being tested: Artificial Food Coloring, Placebo
Keywords: ADHD, Food Additives, Artificial Food Coloring, Diet
Medical subject headings: Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Artificial Food ColoringOther
225mg mixed powdered Artificial Food Coloring (AFC)
PlaceboOther
Placebo chocolate cookies

Study groups in NCT03342469
Study group	Role	What they receive
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. Receives: 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). Receives: 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. Receives: 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). Receives: Other: Artificial Food Coloring; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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)
Measured: 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
Measured: Collected after three days exposure to AFC (on third day) and after three day exposure to placebo (on third day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201815 Oct 2018

First posted17 Nov 2017
Study start1 Jan 2018
Primary completion15 Oct 2018
Study completion15 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: 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.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03342469
Sponsor's protocol ID: IRB-2017-151
Status last verified: Sep 2020
First submitted: 9 Nov 2017
Last updated: 24 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Attention Deficit Hyperactivity Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Food Additives Effects on EEG Profiles in College Students With ADHD
ClinicalTrials.gov ID: NCT03342469
Acronym / sponsor ID: IRB-2017-151
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD, Food Additives, Artificial Food Coloring, Diet
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: American UniversityUniversity, hospital or other
Study start: 1 Jan 2018 (actual)
Primary completion: 15 Oct 2018 (actual)
Study completion: 15 Oct 2018 (actual)
First posted: 17 Nov 2017 (actual)
Results: Posted 24 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4
Model description: 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.

Arm	Type	Receives
ADHD- Artificial food coloring, then placebo	Experimental	Other: Artificial Food Coloring, Other: PlaceboParticipants 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.
ADHD - Placebo, then artificial food coloring	Experimental	Other: Artificial Food Coloring, Other: PlaceboParticipants 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).
Controls- Artificial food coloring, then placebo	Experimental	Other: Artificial Food Coloring, Other: PlaceboParticipants 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.
Controls - Placebo, then artificial food coloring	Experimental	Other: Artificial Food Coloring, Other: PlaceboParticipants 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).

Who may qualify

Ages: 18 to 24 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Artificial Food Coloring225mg mixed powdered Artificial Food Coloring (AFC)	Other	ADHD - Placebo, then artificial food coloring, ADHD- Artificial food coloring, then placebo, Controls - Placebo, then artificial food coloring, Controls- Artificial food coloring, then placebo
PlaceboPlacebo chocolate cookies	Other	ADHD - Placebo, then artificial food coloring, ADHD- Artificial food coloring, then placebo, Controls - Placebo, then artificial food coloring, Controls- Artificial food coloring, then placebo

Primary outcome

Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups
Time frame: Collected after three days exposure to AFC (on third day) and after three day exposure to placebo (on third day)
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
Relative Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups
Time frame: Collected after three days exposure to AFC (on third day) and after three day exposure to placebo (on third day)
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)
ADHD Symptoms During AFC and Placebo Challenge in ADHD and Control Groups
Time frame: Collected after three days exposure to AFC (on third day) and after three day exposure to placebo (on third day)
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

Results and safety

Results posted to the registry on 24 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ADHD- Artificial Food Coloring Challenge First, Then Placebo	9	9
ADHD- Placebo Challenge First, Then Artificial Food Coloring	9	8
Control - Artificial Food Coloring First, Then Placebo	3	3
Control - Placebo First, Then Artificial Food Coloring	8	8

Primary outcome: Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups

Time frame: Collected after three days exposure to AFC (on third day) and after three day exposure to placebo (on third day). Mean (Standard Deviation). Unit: Mean Power (microvolts^2)

Measure	ADHD- Artificial Food Coloring n = 17	ADHD- Placebo n = 17	Control - Artificial Food Coloring n = 11	Control - Placebo n = 11
Mean Delta Power	3.19 (1.93)	3.09 (3.25)	3.50 (2.13)	2.13 (1.07)
Mean Theta Power	1.96 (2.40)	1.60 (1.69)	1.78 (1.27)	1.54 (1.27)
Mean Alpha Power	3.27 (3.19)	3.17 (2.75)	3.05 (2.08)	3.64 (2.48)
Mean Beta Power	0.32 (0.23)	0.25 (0.13)	0.31 (0.21)	0.28 (0.17)
Mean Gamma Power	0.10 (0.08)	0.07 (0.04)	0.10 (0.06)	0.09 (0.05)

ADHD- Artificial Food Coloring vs ADHD- Placebo: p >0.05, repeated measures General Linear Model
ADHD- Artificial Food Coloring vs ADHD- Placebo: p >0.05, repeated measures General Linear Model
ADHD- Artificial Food Coloring vs ADHD- Placebo: p >0.05, repeated measures General Linear Model

Population analysed: Models run for ADHD and control groups, separately.

Primary outcome: Relative Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups

Time frame: Collected after three days exposure to AFC (on third day) and after three day exposure to placebo (on third day). Mean (Standard Deviation). Unit: percentage of total power

Measure	ADHD- Artificial Food Coloring n = 17	ADHD- Placebo n = 17	Control - Artificial Food Coloring n = 11	Control - Placebo n = 11
Relative Delta Power	0.26 (0.07)	0.25 (0.08)	0.27 (0.07)	0.23 (0.04)
Relative Theta Power	0.19 (0.06)	0.18 (0.05)	0.20 (0.07)	0.19 (0.09)
Relative Alpha Power	0.40 (0.11)	0.42 (0.11)	0.39 (0.10)	0.44 (0.10)
Relative Beta Power	0.16 (0.05)	0.16 (0.05)	0.15 (0.04)	0.15 (0.05)
Relative Gamma Power	0.06 (0.03)	0.05 (0.02)	0.06 (0.03)	0.06 (0.03)

ADHD- Artificial Food Coloring vs ADHD- Placebo: p >0.05, repeated measures General Linear Model
ADHD- Artificial Food Coloring vs ADHD- Placebo: p >0.05, repeated measures General Linear Model
ADHD- Artificial Food Coloring vs ADHD- Placebo: p = 0.04, repeated measures General Linear Model

Population analysed: Models run for ADHD and control groups, separately.

Primary outcome: ADHD Symptoms During AFC and Placebo Challenge in ADHD and Control Groups

Time frame: Collected after three days exposure to AFC (on third day) and after three day exposure to placebo (on third day). Mean (Standard Deviation). Unit: score on a scale

Measure	ADHD- Artificial Food Coloring n = 17	ADHD - Placebo Challenge n = 17	Control - Artificial Food Coloring n = 11	Control - Placebo n = 11
Total ASRS	42.06 (13.37)	41.00 (13.03)	24.63 (9.87)	23.81 (11.00)
Inattentive ASRS	23.76 (7.14)	22.71 (6.98)	14.45 (6.06)	14.27 (8.18)
Hyperactive ASRS	18.29 (6.85)	18.24 (6.49)	10.18 (4.47)	9.55 (5.15)

ADHD- Artificial Food Coloring vs ADHD - Placebo Challenge: p >0.05, repeated measures General Linear Model
ADHD- Artificial Food Coloring vs ADHD - Placebo Challenge: p >0.05, repeated measures General Linear Model
ADHD- Artificial Food Coloring vs ADHD - Placebo Challenge: p >0.05, repeated measures General Linear Model

Population analysed: Models run for ADHD and control groups, separately.

Adverse events

Time frame: 4 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Artificial Food Coloring Challenge	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Placebo Challenge	0 of 29 (0%)	0 of 29 (0%)	0 of 29

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kathleen Holton, PhD principal investigator

American University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Artificial Food Coloring in people with Attention Deficit Hyperactivity Disorder, run by American University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups (time frame: Collected after three days exposure to AFC (on third day) and after three day exposure to placebo (on third day)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03342469.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2020.