Clinical trial NCT03342469: Food Additives Effects on EEG Profiles in College Students With ADHD
Official title: Food Additives Effects on EEG Profiles in College Students With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Food Additives
Artificial Food Coloring
Diet
Lead sponsor: American University
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups
timeFrame: Collected after three days exposure to AFC (on third day) and after three day exposure to placebo (on third day)
measure: Relative Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups
timeFrame: Collected after three days exposure to AFC (on third day) and after three day exposure to placebo (on third day)
measure: ADHD Symptoms During AFC and Placebo Challenge in ADHD and Control Groups
timeFrame: Collected after three days exposure to AFC (on third day) and after three day exposure to placebo (on third day)
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: American University
state: District of Columbia
Study officials:
affiliation: American University
name: Kathleen Holton, PhD
role: PRINCIPAL_INVESTIGATOR
References: