Food Additives Effects on Children With ADHD
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 8 - 12 |
| Updated: | 1/13/2018 |
| Start Date: | January 1, 2017 |
| End Date: | August 2018 |
| Contact: | Anna Kirkland |
| Email: | nutrneurolab@american.edu |
| Phone: | (202) 885- 6099 |
The purpose of this study is to examine the effects of food additives on children 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 behavioral changes in children with
ADHD. In this context, food additives will be artificial food coloring.
This study could potentially answer an important question which still remains unanswered as
to whether certain food additives may be able to cause behavioral changes in children with
ADHD. In this context, food additives will be artificial food coloring.
Consent and assent will be obtained at the first visit. Baseline data will be collected on
the children, including height, weight, hemoglobin levels, computerized cognitive
functioning, and an EEG recording. The parent(s) and the child's teacher will be asked to
complete a behavioral assessment over the next two days. The parent(s) will also be taught
how to keep a detailed food and symptom diary over the following week. One week later, the
parent(s) and child will return to the lab and turn in the food/symptom diary. Parent(s) 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, shopping
tips and recipes. For the next two weeks, the family will follow the dietary intervention at
home with access to Dr. Holton to answer any questions. The parents and child will return to
the lab after following the diet for two weeks and assessments (hemoglobin, cognitive
testing, and EEG) will be completed again. The parent(s) and teacher will also fill out a
post-diet behavioral assessment and information on dietary compliance will be collected. The
third meeting will also mark the beginning of the first challenge period. For the challenges,
the child 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 parents and
the child's teacher will fill out a behavioral assessment on Thursday of each week. Children
will be asked not to take ADHD medication on testing days. After two weeks of challenges the
study will be completed. Parents will receive information on their child's performance and on
the study results overall.
the children, including height, weight, hemoglobin levels, computerized cognitive
functioning, and an EEG recording. The parent(s) and the child's teacher will be asked to
complete a behavioral assessment over the next two days. The parent(s) will also be taught
how to keep a detailed food and symptom diary over the following week. One week later, the
parent(s) and child will return to the lab and turn in the food/symptom diary. Parent(s) 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, shopping
tips and recipes. For the next two weeks, the family will follow the dietary intervention at
home with access to Dr. Holton to answer any questions. The parents and child will return to
the lab after following the diet for two weeks and assessments (hemoglobin, cognitive
testing, and EEG) will be completed again. The parent(s) and teacher will also fill out a
post-diet behavioral assessment and information on dietary compliance will be collected. The
third meeting will also mark the beginning of the first challenge period. For the challenges,
the child 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 parents and
the child's teacher will fill out a behavioral assessment on Thursday of each week. Children
will be asked not to take ADHD medication on testing days. After two weeks of challenges the
study will be completed. Parents will receive information on their child's performance and on
the study results overall.
Inclusion Criteria:
- Generally good health
- 8-12 years old
- Currently attending school
- 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
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