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Completed

NCT Number: NCT01856686

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

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.

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Key information

Conditions

ADD ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

7 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

New Remedies

Liverpool, Merseyside, L1 0AH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BP22042013

Drug

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.

Other names: Brain Proteins Supplements

Low Carbohydrate Diet

Dietary Supplement

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

Other names: 2000 Kilo-calories without Fast Absorbing Carbohydrate

Primary outcomes

  1. 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.

  2. 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)

  3. 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)

  4. 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.

  5. 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.

  6. 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

  1. Occipital Alpha Waves-frequency at 3 Months

    Time frame: 3 months

    occipital alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.

  2. Parietal Alpha Waves-frequency at 3 Months

    Time frame: 3 months

    Parietal alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.

  3. Mu Wave Frequency at 3 Months

    Time frame: 3 months

    Mu wave frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.

  4. Frontal Midline Theta Activity- Frequency at 3 Months

    Time frame: 3 months

    Frontal midline theta activity- frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.

  5. Monastra Ratio at 3 Months

    Time frame: 3 months

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

  6. Behavior

    Time frame: 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.

  7. Hyperactivity Score

    Time frame: 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.

  8. Impulsivity Score

    Time frame: 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.

  9. Inattention Score

    Time frame: 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.

Other outcomes

  1. Weight at 3 Months

    Time frame: 3 months

    Weight after 3 months of dietary approach.

  2. Body Mass Index at 3 Months

    Time frame: 3 months

    Body mass index after 3 months of dietary approach.

  3. Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    Time frame: Up to 8 months

    Number of Participants with Adverse Events as a Measure of Safety and Tolerability of Brain Proteins Supplements

Sponsors and collaborators

Lead sponsor

Spanish Foundation for Neurometrics Development

Other

Collaborators

  • Child Health Foundation
  • PronoKal Foundation

Registry information

Acronym: BrainProtein

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 17, 2013
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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