Neurocognitive and Neurobiological Improvement in ADHD Children by Modification of Dietary Protein

Early Phase 1

Completed

Conditions: ADHD
ADD

Interventions: Dietary Supplement: Low carbohydrate diet
Drug: BP22042013

Registration Number: NCT01856686

Lead Sponsor: Spanish Foundation for Neurometrics Development

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 64

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low carbohydrate Diet	Low carbohydrate diet	the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
BP22042013	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.

Primary Outcome Measures

Name	Time	Method
Comission Errors at 3 Months	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	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	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	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	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	3 months	Frontal midline theta activity- amplitude during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.

Secondary Outcome Measures

Name	Time	Method
Mu Wave Frequency at 3 Months	3 months	Mu wave frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Hyperactivity Score	3 months	Hyperactivity assessed by clinical questionnaire after 3 months of nutritional approach. Range: minimum value: 0 and maximum value: 8. Higher values represent a worse outcome.
Occipital Alpha Waves-frequency at 3 Months	3 months	occipital alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Parietal Alpha Waves-frequency at 3 Months	3 months	Parietal alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Monastra Ratio at 3 Months	3 months	Monastra ratio during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Inattention Score	3 months	Inattention assessed by clinical questionnaire after 3 months of nutritional approach. Range: minimum value: 0 and maximum value: 9. Higher values represent a worse outcome.
Behavior	3 months	Behavior assessed by total score of clinical questionnaire (sum of Hyperactivity, Impulsivity and Inattention scores), after 3 months of nutritional approach. Range: minimum value: 0 and maximum value: 25. Higher values represent a worse outcome.
Impulsivity Score	3 months	Impulsivity assessed by clinical questionnaire after 3 months of nutritional approach. Range: minimum value: 0 and maximum value: 8. Higher values represent a worse outcome.
Frontal Midline Theta Activity- Frequency at 3 Months	3 months	Frontal midline theta activity- frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.