Attention Deficit Hyperactivity Disorder
Conditions
Keywords
ADHD, Food Additives, Artificial Food Coloring, Diet
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.
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.
Interventions
OTHERArtificial Food Coloring
225mg mixed powdered Artificial Food Coloring (AFC)
OTHERPlacebo
Placebo chocolate cookies
Sponsors
American University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | 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 | 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 | 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 |
Countries
United States
Participant flow
Recruitment details
Participants with ADHD and neuro-typical controls were recruited from Jan. 2018 until Oct. 2018 at a Mid-Atlantic University.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| ADHD Group College students diagnosed with ADHD. | 18 |
| Control Group College students not diagnosed with ADHD | 11 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | ADHD Group | Total | Control Group |
|---|---|---|---|
| Adult ADHD Self-Report Scale (ASRS) | 43.44 units on a scale STANDARD_DEVIATION 11.3 | 30.03 units on a scale STANDARD_DEVIATION 12.52 | 24.49 units on a scale STANDARD_DEVIATION 8.46 |
| Age, Continuous | 19.0 years | 20 years | 20.0 years |
| Alcohol Use | 18 Participants | 29 Participants | 11 Participants |
| BMI | 22.26 kg/m^2 | 24.10 kg/m^2 | 24.10 kg/m^2 |
| Concussion | 7 Participants | 14 Participants | 7 Participants |
| Diagnoses | 6 Participants | 11 Participants | 5 Participants |
| GPA | 3.45 GPA | 3.5 GPA | 3.60 GPA |
| Head Injury | 7 Participants | 18 Participants | 11 Participants |
| Marijuana Use | 11 Participants | 17 Participants | 6 Participants |
| Medication Use | 13 Participants | 21 Participants | 8 Participants |
| Nicotine Use | 6 Participants | 12 Participants | 6 Participants |
| Other Substance Use | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 21 Participants | 8 Participants |
| Region of Enrollment United States | 18 participants | 29 participants | 11 participants |
| Right Handed | 17 Participants | 28 Participants | 11 Participants |
| Sex: Female, Male Female | 13 Participants | 21 Participants | 8 Participants |
| Sex: Female, Male Male | 5 Participants | 8 Participants | 3 Participants |
| Year in College Freshman | 11 Participants | 13 Participants | 2 Participants |
| Year in College Junior | 3 Participants | 6 Participants | 3 Participants |
| Year in College Senior | 1 Participants | 2 Participants | 1 Participants |
| Year in College Sophmore | 3 Participants | 8 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 29 |
| other Total, other adverse events | 0 / 29 | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 | 0 / 29 |
Outcome results
Primary
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
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ADHD- Artificial Food Coloring | ADHD Symptoms During AFC and Placebo Challenge in ADHD and Control Groups | Hyperactive ASRS | 18.29 score on a scale | Standard Deviation 6.85 |
| ADHD- Artificial Food Coloring | ADHD Symptoms During AFC and Placebo Challenge in ADHD and Control Groups | Total ASRS | 42.06 score on a scale | Standard Deviation 13.37 |
| ADHD- Artificial Food Coloring | ADHD Symptoms During AFC and Placebo Challenge in ADHD and Control Groups | Inattentive ASRS | 23.76 score on a scale | Standard Deviation 7.14 |
| ADHD- Placebo | ADHD Symptoms During AFC and Placebo Challenge in ADHD and Control Groups | Inattentive ASRS | 22.71 score on a scale | Standard Deviation 6.98 |
| ADHD- Placebo | ADHD Symptoms During AFC and Placebo Challenge in ADHD and Control Groups | Total ASRS | 41.00 score on a scale | Standard Deviation 13.03 |
| ADHD- Placebo | ADHD Symptoms During AFC and Placebo Challenge in ADHD and Control Groups | Hyperactive ASRS | 18.24 score on a scale | Standard Deviation 6.49 |
| Control - Artificial Food Coloring | ADHD Symptoms During AFC and Placebo Challenge in ADHD and Control Groups | Inattentive ASRS | 14.45 score on a scale | Standard Deviation 6.06 |
| Control - Artificial Food Coloring | ADHD Symptoms During AFC and Placebo Challenge in ADHD and Control Groups | Total ASRS | 24.63 score on a scale | Standard Deviation 9.87 |
| Control - Artificial Food Coloring | ADHD Symptoms During AFC and Placebo Challenge in ADHD and Control Groups | Hyperactive ASRS | 10.18 score on a scale | Standard Deviation 4.47 |
| Control - Placebo | ADHD Symptoms During AFC and Placebo Challenge in ADHD and Control Groups | Total ASRS | 23.81 score on a scale | Standard Deviation 11 |
| Control - Placebo | ADHD Symptoms During AFC and Placebo Challenge in ADHD and Control Groups | Hyperactive ASRS | 9.55 score on a scale | Standard Deviation 5.15 |
| Control - Placebo | ADHD Symptoms During AFC and Placebo Challenge in ADHD and Control Groups | Inattentive ASRS | 14.27 score on a scale | Standard Deviation 8.18 |
Comparison: Difference in inattentive ASRS in ADHD group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (inattentive ASRS score during AFC, inattentive ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.p-value: >0.05repeated measures General Linear Model
Comparison: Difference in hyperactive ASRS in ADHD group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (hyperactive ASRS score during AFC, hyperactive ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.p-value: >0.05repeated measures General Linear Model
Comparison: Difference in total ASRS in ADHD group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (total ASRS score during AFC, total ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.p-value: >0.05repeated measures General Linear Model
Comparison: inattentive ASRS in control group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (inattentive ASRS score during AFC, inattentive ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.p-value: >0.05repeated measures General Linear Model
Comparison: Hyperactive ASRS in control group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (hyperactive ASRS score during AFC, hyperactive ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.p-value: >0.05repeated measures General Linear Model
Comparison: Difference in total ASRS in control group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (total ASRS score during AFC, total ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.p-value: >0.05repeated measures General Linear Model
Primary
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
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ADHD- Artificial Food Coloring | 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 |
| ADHD- Artificial Food Coloring | 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 |
| ADHD- Artificial Food Coloring | 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 |
| ADHD- Artificial Food Coloring | 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 |
| ADHD- Artificial Food Coloring | Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Mean Theta Power | 1.96 Mean Power (microvolts^2) | Standard Deviation 2.4 |
| ADHD- Placebo | Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Mean Gamma Power | 0.07 Mean Power (microvolts^2) | Standard Deviation 0.04 |
| ADHD- Placebo | Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Mean Delta Power | 3.09 Mean Power (microvolts^2) | Standard Deviation 3.25 |
| ADHD- Placebo | Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Mean Theta Power | 1.60 Mean Power (microvolts^2) | Standard Deviation 1.69 |
| ADHD- Placebo | Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Mean Alpha Power | 3.17 Mean Power (microvolts^2) | Standard Deviation 2.75 |
| ADHD- Placebo | Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Mean Beta Power | 0.25 Mean Power (microvolts^2) | Standard Deviation 0.13 |
| Control - Artificial Food Coloring | Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Mean Alpha Power | 3.05 Mean Power (microvolts^2) | Standard Deviation 2.08 |
| Control - Artificial Food Coloring | Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Mean Theta Power | 1.78 Mean Power (microvolts^2) | Standard Deviation 1.27 |
| Control - Artificial Food Coloring | Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Mean Delta Power | 3.50 Mean Power (microvolts^2) | Standard Deviation 2.13 |
| Control - Artificial Food Coloring | Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Mean Beta Power | 0.31 Mean Power (microvolts^2) | Standard Deviation 0.21 |
| Control - Artificial Food Coloring | Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Mean Gamma Power | 0.10 Mean Power (microvolts^2) | Standard Deviation 0.06 |
| Control - Placebo | Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Mean Beta Power | 0.28 Mean Power (microvolts^2) | Standard Deviation 0.17 |
| Control - Placebo | Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Mean Gamma Power | 0.09 Mean Power (microvolts^2) | Standard Deviation 0.05 |
| Control - Placebo | Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Mean Alpha Power | 3.64 Mean Power (microvolts^2) | Standard Deviation 2.48 |
| Control - Placebo | Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Mean Theta Power | 1.54 Mean Power (microvolts^2) | Standard Deviation 1.27 |
| Control - Placebo | Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Mean Delta Power | 2.13 Mean Power (microvolts^2) | Standard Deviation 1.07 |
Comparison: Difference in Delta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.p-value: >0.05repeated measures General Linear Model
Comparison: Difference in Theta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.p-value: >0.05repeated measures General Linear Model
Comparison: Difference in Alpha Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.p-value: >0.05repeated measures General Linear Model
Comparison: Difference in Beta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.p-value: 0.08repeated measures General Linear Model
Comparison: Difference in Gamma Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.p-value: 0.05repeated measures General Linear Model
Comparison: Difference in Delta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.p-value: >0.05repeated measures General Linear Model
Comparison: Difference in Theta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.p-value: >0.05repeated measures General Linear Model
Comparison: Difference in Alpha Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.p-value: >0.05repeated measures General Linear Model
Comparison: Difference in Beta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)p-value: >0.05repeated measures General Linear Model
Comparison: Difference in Gamma Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.p-value: >0.05repeated measures General Linear Model
Primary
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)
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ADHD- Artificial Food Coloring | 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 |
| ADHD- Artificial Food Coloring | 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 |
| ADHD- Artificial Food Coloring | 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 |
| ADHD- Artificial Food Coloring | 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 |
| ADHD- Artificial Food Coloring | 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 |
| ADHD- Placebo | Relative Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Relative Alpha Power | 0.42 percentage of total power | Standard Deviation 0.11 |
| ADHD- Placebo | 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 |
| ADHD- Placebo | Relative Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Relative Gamma Power | 0.05 percentage of total power | Standard Deviation 0.02 |
| ADHD- Placebo | Relative Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Relative Theta Power | 0.18 percentage of total power | Standard Deviation 0.05 |
| ADHD- Placebo | Relative Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Relative Delta Power | 0.25 percentage of total power | Standard Deviation 0.08 |
| Control - Artificial Food Coloring | Relative Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Relative Alpha Power | 0.39 percentage of total power | Standard Deviation 0.1 |
| Control - Artificial Food Coloring | Relative Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Relative Theta Power | 0.20 percentage of total power | Standard Deviation 0.07 |
| Control - Artificial Food Coloring | Relative Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Relative Delta Power | 0.27 percentage of total power | Standard Deviation 0.07 |
| Control - Artificial Food Coloring | Relative Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Relative Beta Power | 0.15 percentage of total power | Standard Deviation 0.04 |
| Control - Artificial Food Coloring | 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 |
| Control - Placebo | Relative Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Relative Beta Power | 0.15 percentage of total power | Standard Deviation 0.05 |
| Control - Placebo | Relative Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Relative Theta Power | 0.19 percentage of total power | Standard Deviation 0.09 |
| Control - Placebo | Relative Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Relative Delta Power | 0.23 percentage of total power | Standard Deviation 0.04 |
| Control - Placebo | Relative Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups | Relative Alpha Power | 0.44 percentage of total power | Standard Deviation 0.1 |
| Control - Placebo | 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 |
Comparison: Difference in Delta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.p-value: >0.05repeated measures General Linear Model
Comparison: Difference in Theta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.p-value: >0.05repeated measures General Linear Model
Comparison: Difference in Alpha Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.p-value: 0.04repeated measures General Linear Model
Comparison: Difference in Beta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.p-value: >0.05repeated measures General Linear Model
Comparison: Difference in Gamma Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.p-value: >0.05repeated measures General Linear Model
Comparison: Difference in Delta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.p-value: >0.05repeated measures General Linear Model
Comparison: Difference in Theta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisonsp-value: >0.05repeated measures General Linear Model
Comparison: Difference in Alpha Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.p-value: >0.05repeated measures General Linear Model
Comparison: Difference in Beta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.p-value: >0.05repeated measures General Linear Model
Comparison: Difference in Gamma Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.p-value: >0.05repeated measures General Linear Model