Food Additives Effects on EEG Profiles in College Students With ADHD

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-10-15

Brief Summary

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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.

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Detailed Description

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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

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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ADHD- Artificial food coloring, then placebo

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.

Group Type EXPERIMENTAL

Artificial Food Coloring

Intervention Type OTHER

225mg mixed powdered Artificial Food Coloring (AFC)

Placebo

Intervention Type OTHER

Placebo chocolate cookies

ADHD - Placebo, then artificial food coloring

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).

Group Type EXPERIMENTAL

Artificial Food Coloring

Intervention Type OTHER

225mg mixed powdered Artificial Food Coloring (AFC)

Placebo

Intervention Type OTHER

Placebo chocolate cookies

Controls- Artificial food coloring, then placebo

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.

Group Type EXPERIMENTAL

Artificial Food Coloring

Intervention Type OTHER

225mg mixed powdered Artificial Food Coloring (AFC)

Placebo

Intervention Type OTHER

Placebo chocolate cookies

Controls - Placebo, then artificial food coloring

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).

Group Type EXPERIMENTAL

Artificial Food Coloring

Intervention Type OTHER

225mg mixed powdered Artificial Food Coloring (AFC)

Placebo

Intervention Type OTHER

Placebo chocolate cookies

Interventions

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Artificial Food Coloring

225mg mixed powdered Artificial Food Coloring (AFC)

Intervention Type OTHER

Placebo

Placebo chocolate cookies

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes