Attention Deficit Disorder With Hyperactivity
Conditions
Keywords
ADHD, Diet, Functional Magnetic Resonance Imaging
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTRestricted Diet
Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.
DIETARY_SUPPLEMENTRuse Diet
Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Age 9-12 years * Meets criteria for Attention Deficit Hyperactivity Disorder * Parent must agree to use Study Diet Manual
Exclusion criteria
* Any Axis I psychiatric disorder other than Oppositional Defiant Disorder or Anxiety Disorder not requiring psychopharmacological management * Not currently on any pharmacological agent other than medication for ADHD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ADHD Rating Scale IV | 5 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Recruited through advertisement in magazines and flyers posted in child psychiatry clinics
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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 | 14 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Protocol Violation | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | Ruse Diet | Restricted Diet | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 14 Participants | 15 Participants | 29 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 10.83 years STANDARD_DEVIATION 1.25 | 10.8 years STANDARD_DEVIATION 1.73 | 10.82 years STANDARD_DEVIATION 1.49 |
| Region of Enrollment United States | 14 participants | 15 participants | 29 participants |
| Sex: Female, Male Female | 9 Participants | 1 Participants | 10 Participants |
| Sex: Female, Male Male | 5 Participants | 14 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 15 | 1 / 14 |
| serious Total, serious adverse events | 0 / 15 | 0 / 14 |
Outcome results
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.
Time frame: 5 weeks
Population: Children with ADHD who completed the five week diet and parents filled out the ADHD rating scale.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Restricted Diet | ADHD Rating Scale IV | 18.0 units on a scale | Standard Deviation 10.9 |
| Ruse Diet | ADHD Rating Scale IV | 21.3 units on a scale | Standard Deviation 11.75 |