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Neurocognitive and Neurobiological Improvement in ADHD Children With High Protein Diet (BrainProtein)

Primary Purpose

ADD, ADHD

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
BP22042013
Low carbohydrate diet
Sponsored by
Spanish Foundation for Neurometrics Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for ADD focused on measuring ADD, ADHD, Proteins, Dietary, Nutrition, QEEG, ERP, ICA

Eligibility Criteria

7 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    BP22042013

    Low carbohydrate Diet

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    Changes Related Potential Recording after 3 months of dietary approach
    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 Outcome Measures

    Quantitative Electroencephalogram
    Analysis frequencies and amplitudes of brainwaves and spectral independent components before and after 3 months of nutritional intervention
    Behavior
    Evaluate Behavior with clinical scales (AMEN questionnaire) at the beginning and after 3 months of nutritional approach.

    Full Information

    First Posted
    April 22, 2013
    Last Updated
    April 7, 2021
    Sponsor
    Spanish Foundation for Neurometrics Development
    Collaborators
    PronoKal Foundation, Child Health Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02614599
    Brief Title
    Neurocognitive and Neurobiological Improvement in ADHD Children With High Protein Diet
    Acronym
    BrainProtein
    Official Title
    Neurocognitive and Neurobiological Improvement in ADHD Children by Modification of Dietary Protein
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Spanish Foundation for Neurometrics Development
    Collaborators
    PronoKal Foundation, Child Health Foundation

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ADD, ADHD
    Keywords
    ADD, ADHD, Proteins, Dietary, Nutrition, QEEG, ERP, ICA

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    BP22042013
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Low carbohydrate Diet
    Arm Type
    Experimental
    Arm Description
    the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
    Intervention Type
    Drug
    Intervention Name(s)
    BP22042013
    Other Intervention Name(s)
    Brain Proteins Supplements
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Low carbohydrate diet
    Other Intervention Name(s)
    2000 Kilo-calories without Fast Absorbing Carbohydrate
    Intervention Description
    the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements
    Primary Outcome Measure Information:
    Title
    Changes Related Potential Recording after 3 months of dietary approach
    Description
    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.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Quantitative Electroencephalogram
    Description
    Analysis frequencies and amplitudes of brainwaves and spectral independent components before and after 3 months of nutritional intervention
    Time Frame
    3 months
    Title
    Behavior
    Description
    Evaluate Behavior with clinical scales (AMEN questionnaire) at the beginning and after 3 months of nutritional approach.
    Time Frame
    3 months
    Other Pre-specified Outcome Measures:
    Title
    Change in Weight
    Description
    Change from Baseline in Weight after 3 months of nutritional intervention
    Time Frame
    3 months
    Title
    Change in body mass index
    Description
    Change in body mass index after 3 months of nutritional intervention.
    Time Frame
    3 months
    Title
    Change in body composition
    Description
    Change in body composition using bioelectrical impedance after 3 months of nutritional intervention.
    Time Frame
    3 months
    Title
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability
    Description
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability of Brain Proteins Supplements
    Time Frame
    From April to December 2013

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Links:
    URL
    http://www.brainmech.org
    Description
    Brainmech Foundation
    URL
    http://www.qeeg.es
    Description
    Neurometrics
    URL
    http://www.fundacionsaludinfantil.org
    Description
    Children Health Foundation
    URL
    http://www.fundacionpronokal.org/
    Description
    Pronokal Foundation

    Learn more about this trial

    Neurocognitive and Neurobiological Improvement in ADHD Children With High Protein Diet

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