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
- 100
- Primary Endpoint
- Changes Related Potential Recording after 3 months of dietary approach
- Status
- Completed
- Last Updated
- 5 years ago
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
We 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
Changes Related Potential Recording after 3 months of dietary approach
Time Frame: 3 months
Evaluate changes in reaction time, omission and comission errors, latencies and amplitudes in brainwaves during visual continuous performance task from 19 channels EEG recordings, before begin nutritional measures and after 3 months of dietary approach.
Secondary Outcomes
- Quantitative Electroencephalogram(3 months)
- Behavior(3 months)