Neurocognitive and Neurobiological Improvement in ADHD Children by Modification of Dietary Protein
Overview
- Phase
- Early Phase 1
- Intervention
- BP22042013
- Conditions
- ADD
- Sponsor
- Spanish Foundation for Neurometrics Development
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Comission Errors at 3 Months
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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
- •diuretic or cortisone treatment
- •haematological problems
- •suprarenal diseases
- •Brain injury
- •Cardiovascular or arrhythmia problems
Arms & Interventions
BP22042013
This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
Intervention: BP22042013
Low carbohydrate Diet
the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
Intervention: Low carbohydrate diet
Outcomes
Primary Outcomes
Comission Errors at 3 Months
Time Frame: 3 months
comission errors during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.(Test duration: 22 minutes)
Reaction Time at 3 Months
Time Frame: 3 months
Reaction time during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Omission Errors at 3 Months
Time Frame: 3 months
Omission errors during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. (Test duration: 22 minutes)
Occipital Alpha Brainwaves Amplitudes at 3 Months
Time Frame: 3 months
occipital alpha waves amplitudes during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Mu Waves-amplitude at 3 Months
Time Frame: 3 months
Mu waves-amplitude during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Frontal Midline Theta Activity- Amplitude at 3 Months
Time Frame: 3 months
Frontal midline theta activity- amplitude during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Secondary Outcomes
- Mu Wave Frequency at 3 Months(3 months)
- Hyperactivity Score(3 months)
- Occipital Alpha Waves-frequency at 3 Months(3 months)
- Parietal Alpha Waves-frequency at 3 Months(3 months)
- Monastra Ratio at 3 Months(3 months)
- Inattention Score(3 months)
- Behavior(3 months)
- Impulsivity Score(3 months)
- Frontal Midline Theta Activity- Frequency at 3 Months(3 months)