Food Additives Effects on EEG Profiles in College Students With ADHD

American University

Status: Completed

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Other: Placebo; Other: Artificial Food Coloring

Study type: Interventional

Funder types: Other

Identifiers

NCT03342469

IRB-2017-151

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 24 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

29 participants in 4 patient groups

ADHD- Artificial food coloring, then placebo

Experimental group

Description:

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.

Treatment:

Other: Placebo

Other: Artificial Food Coloring

ADHD - Placebo, then artificial food coloring

Experimental group

Description:

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).

Treatment:

Other: Placebo

Other: Artificial Food Coloring

Controls- Artificial food coloring, then placebo

Experimental group

Description:

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.

Treatment:

Other: Placebo

Other: Artificial Food Coloring

Controls - Placebo, then artificial food coloring

Experimental group

Description:

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).

Treatment:

Other: Placebo

Other: Artificial Food Coloring