Trial Outcomes & Findings for Food Additives Effects on EEG Profiles in College Students With ADHD (NCT NCT03342469)
NCT ID: NCT03342469
Last Updated: 2020-09-24
Results Overview
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
COMPLETED
NA
29 participants
Collected after three days exposure to AFC (on third day) and after three day exposure to placebo (on third day)
2020-09-24
Participant Flow
Participants with ADHD and neuro-typical controls were recruited from Jan. 2018 until Oct. 2018 at a Mid-Atlantic University.
Two-week AFC-free diet to standardize intake before randomization to challenge with AFC relative to placebo. Washout period of 4 days between challenge with AFC and placebo.
Participant milestones
| Measure |
ADHD- Artificial Food Coloring Challenge First, Then Placebo
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. The next week they will received placebo cookies for three days.
Artificial Food Coloring: Artificial Food Coloring (AFC)
|
ADHD- Placebo Challenge First, Then Artificial Food Coloring
The participants will consume chocolate cookies with no food coloring for three days. The next week a high consumer 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).
|
Control - Artificial Food Coloring First, Then Placebo
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. The next week they will received placebo cookies for three days.
|
Control - Placebo First, Then Artificial Food Coloring
The participants will consume chocolate cookies with no food coloring for three days. The next week a high consumer 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).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
3
|
8
|
|
Overall Study
COMPLETED
|
9
|
8
|
3
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
ADHD- Artificial Food Coloring Challenge First, Then Placebo
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. The next week they will received placebo cookies for three days.
Artificial Food Coloring: Artificial Food Coloring (AFC)
|
ADHD- Placebo Challenge First, Then Artificial Food Coloring
The participants will consume chocolate cookies with no food coloring for three days. The next week a high consumer 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).
|
Control - Artificial Food Coloring First, Then Placebo
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. The next week they will received placebo cookies for three days.
|
Control - Placebo First, Then Artificial Food Coloring
The participants will consume chocolate cookies with no food coloring for three days. The next week a high consumer 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).
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Food Additives Effects on EEG Profiles in College Students With ADHD
Baseline characteristics by cohort
| Measure |
ADHD Group
n=18 Participants
College students diagnosed with ADHD.
|
Control Group
n=11 Participants
College students not diagnosed with ADHD
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.0 years
n=5 Participants
|
20.0 years
n=7 Participants
|
20 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
11 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
BMI
|
22.26 kg/m^2
n=5 Participants
|
24.10 kg/m^2
n=7 Participants
|
24.10 kg/m^2
n=5 Participants
|
|
GPA
|
3.45 GPA
n=5 Participants
|
3.60 GPA
n=7 Participants
|
3.5 GPA
n=5 Participants
|
|
Adult ADHD Self-Report Scale (ASRS)
|
43.44 units on a scale
STANDARD_DEVIATION 11.3 • n=5 Participants
|
24.49 units on a scale
STANDARD_DEVIATION 8.46 • n=7 Participants
|
30.03 units on a scale
STANDARD_DEVIATION 12.52 • n=5 Participants
|
|
Right Handed
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Year in College
Freshman
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Year in College
Sophmore
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Year in College
Junior
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Year in College
Senior
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Head Injury
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Concussion
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Diagnoses
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Medication Use
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Alcohol Use
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Nicotine Use
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Marijuana Use
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Other Substance Use
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Collected after three days exposure to AFC (on third day) and after three day exposure to placebo (on third day)Population: Models run for ADHD and control groups, separately.
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
Outcome measures
| Measure |
ADHD- Artificial Food Coloring
n=17 Participants
225 mg AFC over three days received either the first or second week.
|
ADHD- Placebo
n=17 Participants
Placebo cookies over three days received either the first for second week.
|
Control - Artificial Food Coloring
n=11 Participants
225 mg AFC over three days received either the first or second week.
|
Control - Placebo
n=11 Participants
Placebo cookies over three days received either the first or second week.
|
|---|---|---|---|---|
|
Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups
Mean Delta Power
|
3.19 Mean Power (microvolts^2)
Standard Deviation 1.93
|
3.09 Mean Power (microvolts^2)
Standard Deviation 3.25
|
3.50 Mean Power (microvolts^2)
Standard Deviation 2.13
|
2.13 Mean Power (microvolts^2)
Standard Deviation 1.07
|
|
Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups
Mean Theta Power
|
1.96 Mean Power (microvolts^2)
Standard Deviation 2.40
|
1.60 Mean Power (microvolts^2)
Standard Deviation 1.69
|
1.78 Mean Power (microvolts^2)
Standard Deviation 1.27
|
1.54 Mean Power (microvolts^2)
Standard Deviation 1.27
|
|
Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups
Mean Alpha Power
|
3.27 Mean Power (microvolts^2)
Standard Deviation 3.19
|
3.17 Mean Power (microvolts^2)
Standard Deviation 2.75
|
3.05 Mean Power (microvolts^2)
Standard Deviation 2.08
|
3.64 Mean Power (microvolts^2)
Standard Deviation 2.48
|
|
Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups
Mean Beta Power
|
0.32 Mean Power (microvolts^2)
Standard Deviation 0.23
|
0.25 Mean Power (microvolts^2)
Standard Deviation 0.13
|
0.31 Mean Power (microvolts^2)
Standard Deviation 0.21
|
0.28 Mean Power (microvolts^2)
Standard Deviation 0.17
|
|
Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups
Mean Gamma Power
|
0.10 Mean Power (microvolts^2)
Standard Deviation 0.08
|
0.07 Mean Power (microvolts^2)
Standard Deviation 0.04
|
0.10 Mean Power (microvolts^2)
Standard Deviation 0.06
|
0.09 Mean Power (microvolts^2)
Standard Deviation 0.05
|
PRIMARY outcome
Timeframe: Collected after three days exposure to AFC (on third day) and after three day exposure to placebo (on third day)Population: Models run for ADHD and control groups, separately.
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)
Outcome measures
| Measure |
ADHD- Artificial Food Coloring
n=17 Participants
225 mg AFC over three days received either the first or second week.
|
ADHD- Placebo
n=17 Participants
Placebo cookies over three days received either the first for second week.
|
Control - Artificial Food Coloring
n=11 Participants
225 mg AFC over three days received either the first or second week.
|
Control - Placebo
n=11 Participants
Placebo cookies over three days received either the first or second week.
|
|---|---|---|---|---|
|
Relative Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups
Relative Delta Power
|
0.26 percentage of total power
Standard Deviation 0.07
|
0.25 percentage of total power
Standard Deviation 0.08
|
0.27 percentage of total power
Standard Deviation 0.07
|
0.23 percentage of total power
Standard Deviation 0.04
|
|
Relative Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups
Relative Beta Power
|
0.16 percentage of total power
Standard Deviation 0.05
|
0.16 percentage of total power
Standard Deviation 0.05
|
0.15 percentage of total power
Standard Deviation 0.04
|
0.15 percentage of total power
Standard Deviation 0.05
|
|
Relative Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups
Relative Theta Power
|
0.19 percentage of total power
Standard Deviation 0.06
|
0.18 percentage of total power
Standard Deviation 0.05
|
0.20 percentage of total power
Standard Deviation 0.07
|
0.19 percentage of total power
Standard Deviation 0.09
|
|
Relative Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups
Relative Alpha Power
|
0.40 percentage of total power
Standard Deviation 0.11
|
0.42 percentage of total power
Standard Deviation 0.11
|
0.39 percentage of total power
Standard Deviation 0.10
|
0.44 percentage of total power
Standard Deviation 0.10
|
|
Relative Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups
Relative Gamma Power
|
0.06 percentage of total power
Standard Deviation 0.03
|
0.05 percentage of total power
Standard Deviation 0.02
|
0.06 percentage of total power
Standard Deviation 0.03
|
0.06 percentage of total power
Standard Deviation 0.03
|
PRIMARY outcome
Timeframe: Collected after three days exposure to AFC (on third day) and after three day exposure to placebo (on third day)Population: Models run for ADHD and control groups, separately.
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
Outcome measures
| Measure |
ADHD- Artificial Food Coloring
n=17 Participants
225 mg AFC over three days received either the first or second week.
|
ADHD- Placebo
n=17 Participants
Placebo cookies over three days received either the first for second week.
|
Control - Artificial Food Coloring
n=11 Participants
225 mg AFC over three days received either the first or second week.
|
Control - Placebo
n=11 Participants
Placebo cookies over three days received either the first or second week.
|
|---|---|---|---|---|
|
ADHD Symptoms During AFC and Placebo Challenge in ADHD and Control Groups
Total ASRS
|
42.06 score on a scale
Standard Deviation 13.37
|
41.00 score on a scale
Standard Deviation 13.03
|
24.63 score on a scale
Standard Deviation 9.87
|
23.81 score on a scale
Standard Deviation 11.00
|
|
ADHD Symptoms During AFC and Placebo Challenge in ADHD and Control Groups
Inattentive ASRS
|
23.76 score on a scale
Standard Deviation 7.14
|
22.71 score on a scale
Standard Deviation 6.98
|
14.45 score on a scale
Standard Deviation 6.06
|
14.27 score on a scale
Standard Deviation 8.18
|
|
ADHD Symptoms During AFC and Placebo Challenge in ADHD and Control Groups
Hyperactive ASRS
|
18.29 score on a scale
Standard Deviation 6.85
|
18.24 score on a scale
Standard Deviation 6.49
|
10.18 score on a scale
Standard Deviation 4.47
|
9.55 score on a scale
Standard Deviation 5.15
|
Adverse Events
Artificial Food Coloring Challenge
Placebo Challenge
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place