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

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.

Study Overview

• Status: Completed
• Conditions: ADHD; ADD
• Intervention / Treatment: Drug: BP22042013; Dietary supplement: Low carbohydrate diet

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Spain
    • Liverpool, Spain, United Kingdom, L4 5QL
      • Moises Aguilar Domingo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BP22042013; 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.	Drug: BP22042013; 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
Experimental: Low carbohydrate Diet; the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements	Dietary supplement: Low carbohydrate diet; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight at 3 Months	Weight after 3 months of dietary approach.	3 months
Body Mass Index at 3 Months	Body mass index after 3 months of dietary approach.	3 months
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	Number of Participants with Adverse Events as a Measure of Safety and Tolerability of Brain Proteins Supplements	Up to 8 months

Collaborators and Investigators

• Sponsor: Spanish Foundation for Neurometrics Development
• Collaborators: PronoKal Foundation; Child Health Foundation
• Investigators: Principal Investigator: Moises Aguilar-Domingo, PhD, Spanish Foundation for Neurometrics Development

Publications and helpful links

Helpful Links

• Children Health Foundation
• Pronokal Foundation
• Brainmech Foundation

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: May 14, 2013
• First Submitted That Met QC Criteria: May 16, 2013
• First Posted (Estimated): May 17, 2013

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: July 30, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: ADHD; Nutrition; Proteins; ADD; Dietary; ERP; QEEG; ICA
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: Brain Proteins