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Children with Attention Deficit Hyperactivity Disorder (ADHD) aged 9-12 years of age will be placed on a restriction diet for a 5 week period. Children will be randomized to either receive daily snacks that conform to the diet or will violate the diet (Ruse diet) in a double blind fashion. It is hypothesized that children who are consistently on the restricted diet (relative to those on the ruse diet) will show improvements in ADHD symptoms.
The ADHD rating scale (RS) will be the principal behavioral outcome measure. We hypothesize that children on restriction diet will have significantly lower ADHD RS scores after 5 weeks relative to the Ruse diet group. In addition children will undergo functional magnetic resonance imaging (fMRI) at baseline and again at 5 weeks. Children will perform a flanker task known to engage the dorsolateral prefrontal cortex (DLPFC) and the anterior cingulate cortex (ACC) during attention tasks. The children will also perform will look at pictures of appealing and unappealing food and rate whether they would like to eat it or not. This task is known to activate the ventral striatum (VS) (reward processing). A secondary hypothesis is whether children on the restricted diet will show changes in activity and connectivity of areas (DLPFC, ACC, VS) relative to those on the Ruse diet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restricted Diet | Experimental | Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet. |
|
| Ruse Diet | Sham Comparator | Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restricted Diet | Dietary Supplement | Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ADHD Rating Scale IV | The ADHD Rating Scale is an 18 items scale containing items related to the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD). It is filled out by the parent. Each item is rated 0-3, the range of scores is 0 to 54, with 25 being the score below which the patient is considered to be in remission. Reference: DuPaul GJ, Power TJ, Anastopoulos AD, Reid R: ADHD Rating Scales-IV: Checklists, Norms and Clinical Interpretation. New York, Guilford Press; 1998. | 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stevn R Pliszka, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
40 children were enrolled, a total of 29 were randomized. Of the remaining 11, 8 were screen failures, 3 withdrew from the study prior to randomization.
Recruited through advertisement in magazines and flyers posted in child psychiatry clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Restricted Diet | Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet. Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet. |
| FG001 | Ruse Diet | Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet. Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Children age 9 to 12 with ADHD.
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| ID | Title | Description |
|---|---|---|
| BG000 | Restricted Diet | Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet. Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet. |
| BG001 | Ruse Diet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | ADHD Rating Scale IV | The ADHD Rating Scale is an 18 items scale containing items related to the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD). It is filled out by the parent. Each item is rated 0-3, the range of scores is 0 to 54, with 25 being the score below which the patient is considered to be in remission. Reference: DuPaul GJ, Power TJ, Anastopoulos AD, Reid R: ADHD Rating Scales-IV: Checklists, Norms and Clinical Interpretation. New York, Guilford Press; 1998. | Children with ADHD who completed the five week diet and parents filled out the ADHD rating scale. | Posted | Mean | Standard Deviation | units on a scale | 5 weeks |
|
18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Restricted Diet | Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet. Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven R. Pliszka MD | The University of Texas Health Science Center at San Antonio | 210-567-0136 | pliszka@uthscsa.edu |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Ruse Diet | Dietary Supplement | Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet. Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Ruse Diet | Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet. Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet |
|
|
| 0 |
| 15 |
| 5 |
| 15 |
| EG001 | Ruse Diet | Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet. Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet | 0 | 14 | 1 | 14 |
| Acid Reflux | Gastrointestinal disorders | Non-systematic Assessment |
|
| Streptococcus Throat Infection | Infections and infestations | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
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