Clinical trial NCT01856686: Neurocognitive and Neurobiological Improvement in ADHD Children by Modification of Dietary Protein
Official title: Neurocognitive and Neurobiological Improvement in ADHD Children by Modification of Dietary Protein
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: ADD
ADHD
Keywords: ADD
ADHD
Proteins
Dietary
Nutrition
QEEG
ERP
ICA
Lead sponsor: Spanish Foundation for Neurometrics Development
Sponsor class: OTHER
Collaborators: name: PronoKal Foundation
name: Child Health Foundation
First posted: 2013-05-17
Enrollment: 64
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Multicenter, Prospective, randomized, comparative and controlled study about the beneficial effects in behavior and brain connectivity of different dietary patterns in 100 children with ADHD between 7 and 12 years, followed up for 3 months of nutritional therapy.

Detailed description: The investigators collect electroencephalogram (EEG), event related potentials (ERP) data, and behavior parameters in ADD/ADHD children that not take stimulants or other drugs during study. They would only follow some nutritional recommendations based on increasing the amount of dietary protein and fast carbohydrates decrease. The duration of the study will be 6 months, 3 months for recruitment and 3 months for dietary treatment.

Eligibility criteria: Inclusion Criteria:

* ADHD diagnosed 12 months before
* no take medication
* BMI above the 25th percentile
* Wiesel score between 80 and 100 (about 120)
* Patients who agree to participate and whose guardians signed the informed consent form

Exclusion Criteria:

* eating disorders
* psychosis, bipolar disorder or depression
* kidney or liver failure
* diabetes
* diuretic or cortisone treatment
* haematological problems
* suprarenal diseases
* cancer
* Brain injury
* Cardiovascular or arrhythmia problems

Primary outcomes:
measure: Reaction Time at 3 Months
timeFrame: 3 months
measure: Omission Errors at 3 Months
timeFrame: 3 months
measure: Comission Errors at 3 Months
timeFrame: 3 months
measure: Occipital Alpha Brainwaves Amplitudes at 3 Months
timeFrame: 3 months
measure: Mu Waves-amplitude at 3 Months
timeFrame: 3 months
measure: Frontal Midline Theta Activity- Amplitude at 3 Months
timeFrame: 3 months
Secondary outcomes:
measure: Occipital Alpha Waves-frequency at 3 Months
timeFrame: 3 months
measure: Parietal Alpha Waves-frequency at 3 Months
timeFrame: 3 months
measure: Mu Wave Frequency at 3 Months
timeFrame: 3 months
measure: Frontal Midline Theta Activity- Frequency at 3 Months
timeFrame: 3 months
measure: Monastra Ratio at 3 Months
timeFrame: 3 months
measure: Behavior
timeFrame: 3 months
measure: Hyperactivity Score
timeFrame: 3 months
measure: Impulsivity Score
timeFrame: 3 months
measure: Inattention Score
timeFrame: 3 months
Other outcomes:
measure: Weight at 3 Months
timeFrame: 3 months
measure: Body Mass Index at 3 Months
timeFrame: 3 months
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 8 months
Locations:
city: Liverpool
country: United Kingdom
facility: New Remedies
state: Merseyside
Study officials:
affiliation: Spanish Foundation for Neurometrics Development
name: Moises Aguilar-Domingo, PhD
role: PRINCIPAL_INVESTIGATOR
References: