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

Primary Purpose

ADD, ADHD

Status
Completed
Phase
Early Phase 1
Locations
United Kingdom
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 SexesDoes not accept 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

  • Moises Aguilar Domingo

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

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

Secondary Outcome Measures

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

Full Information

First Posted
May 14, 2013
Last Updated
July 30, 2023
Sponsor
Spanish Foundation for Neurometrics Development
Collaborators
PronoKal Foundation, Child Health Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01856686
Brief Title
Neurocognitive and Neurobiological Improvement in ADHD Children by Modification of Dietary Protein
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
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 2014 (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
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.

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
64 (Actual)

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
Reaction Time at 3 Months
Description
Reaction time during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Time Frame
3 months
Title
Omission Errors at 3 Months
Description
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
Title
Comission Errors at 3 Months
Description
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
Title
Occipital Alpha Brainwaves Amplitudes at 3 Months
Description
occipital alpha waves amplitudes during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Time Frame
3 months
Title
Mu Waves-amplitude at 3 Months
Description
Mu waves-amplitude during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Time Frame
3 months
Title
Frontal Midline Theta Activity- Amplitude at 3 Months
Description
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 Outcome Measure Information:
Title
Occipital Alpha Waves-frequency at 3 Months
Description
occipital alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Time Frame
3 months
Title
Parietal Alpha Waves-frequency at 3 Months
Description
Parietal alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Time Frame
3 months
Title
Mu Wave Frequency at 3 Months
Description
Mu wave frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Time Frame
3 months
Title
Frontal Midline Theta Activity- Frequency at 3 Months
Description
Frontal midline theta activity- frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Time Frame
3 months
Title
Monastra Ratio at 3 Months
Description
Monastra ratio during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Time Frame
3 months
Title
Behavior
Description
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.
Time Frame
3 months
Title
Hyperactivity Score
Description
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.
Time Frame
3 months
Title
Impulsivity Score
Description
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.
Time Frame
3 months
Title
Inattention Score
Description
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.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Weight at 3 Months
Description
Weight after 3 months of dietary approach.
Time Frame
3 months
Title
Body Mass Index at 3 Months
Description
Body mass index after 3 months of dietary approach.
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
Up to 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moises Aguilar-Domingo, PhD
Organizational Affiliation
Spanish Foundation for Neurometrics Development
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moises Aguilar Domingo
City
Liverpool
State/Province
Spain
ZIP/Postal Code
L4 5QL
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.deepbrain.uk
Description
Brainmech Foundation
URL
http://www.fundacionsaludinfantil.org
Description
Children Health Foundation
URL
http://www.fundacionpronokal.org/
Description
Pronokal Foundation

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

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