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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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ADD, ADHD

Intervention / Treatment
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* Drug: BP22042013
* Dietary Supplement: Low carbohydrate diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BP22042013<br>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. | Drug: BP22042013<br>* This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.<br>* Other names: Brain Proteins Supplements;|
| Experimental: Low carbohydrate Diet<br>the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements | Dietary Supplement: Low carbohydrate diet<br>* the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements<br>* Other names: 2000 Kilo-calories without Fast Absorbing Carbohydrate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaction Time at 3 Months | Reaction time during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. | 3 months | 
| Omission Errors at 3 Months | Omission errors during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. (Test duration: 22 minutes) | 3 months | 
| Comission Errors at 3 Months | comission errors during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.(Test duration: 22 minutes) | 3 months | 
| Occipital Alpha Brainwaves Amplitudes at 3 Months | occipital alpha waves amplitudes during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. | 3 months | 
| Mu Waves-amplitude at 3 Months | Mu waves-amplitude during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. | 3 months | 
| Frontal Midline Theta Activity- Amplitude at 3 Months | Frontal midline theta activity- amplitude during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occipital Alpha Waves-frequency at 3 Months | occipital alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. | 3 months | 
| Parietal Alpha Waves-frequency at 3 Months | Parietal alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. | 3 months | 
| Mu Wave Frequency at 3 Months | Mu wave frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. | 3 months | 
| Frontal Midline Theta Activity- Frequency at 3 Months | Frontal midline theta activity- frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. | 3 months | 
| Monastra Ratio at 3 Months | Monastra ratio during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. | 3 months | 
| Behavior | 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. | 3 months | 
| Hyperactivity Score | 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. | 3 months | 
| Impulsivity Score | 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. | 3 months | 
| Inattention Score | 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADD, ADHD, Proteins, Dietary, Nutrition, QEEG, ERP, ICA