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

Early Phase 1CompletedNCT01856686

Spanish Foundation for Neurometrics Development64 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

ADD ADHD

Interventions

BP22042013DRUG

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.

Low carbohydrate dietDIETARY_SUPPLEMENT

the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements

Eligibility

Sex: ALLMin age: 7 YearsMax age: 13 Years

Medical Language ↔ Plain English

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

Locations (1)

New Remedies

Liverpool, Merseyside, United Kingdom

Outcomes

Primary Outcomes

Reaction Time at 3 Months

Reaction time during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.

Time frame: 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)

Time frame: 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)

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 3 months

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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