Skip to main content
OpenTrials
Completed

NCT Number: NCT02614599

Neurocognitive and Neurobiological Improvement in ADHD Children With High Protein Diet

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.

Completed

Looking for future studies?

Notify Me

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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. 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

  1. Quantitative Electroencephalogram

    Time frame: 3 months

    Analysis frequencies and amplitudes of brainwaves and spectral independent components before and after 3 months of nutritional intervention

  2. Behavior

    Time frame: 3 months

    Evaluate Behavior with clinical scales (AMEN questionnaire) at the beginning and after 3 months of nutritional approach.

Other outcomes

  1. Change in Weight

    Time frame: 3 months

    Change from Baseline in Weight after 3 months of nutritional intervention

  2. Change in body mass index

    Time frame: 3 months

    Change in body mass index after 3 months of nutritional intervention.

  3. Change in body composition

    Time frame: 3 months

    Change in body composition using bioelectrical impedance after 3 months of nutritional intervention.

  4. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: From April to December 2013

    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

Official study title

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

Acronym: BrainProtein

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 25, 2015
Registry last updated
Apr 8, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.