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

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.

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

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

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
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.	3 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weight	Change from Baseline in Weight after 3 months of nutritional intervention	3 months
Change in body mass index	Change in body mass index after 3 months of nutritional intervention.	3 months
Change in body composition	Change in body composition using bioelectrical impedance after 3 months of nutritional intervention.	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	From April to December 2013

Collaborators and Investigators

• Sponsor: Spanish Foundation for Neurometrics Development
• Collaborators: PronoKal Foundation; Child Health Foundation

Publications and helpful links

Helpful Links

• Neurometrics
• Brainmech Foundation
• Children Health Foundation
• Pronokal Foundation

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: April 22, 2013
• First Submitted That Met QC Criteria: November 21, 2015
• First Posted (Estimate): November 25, 2015

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: ADHD; Nutrition; Proteins; ADD; Dietary; ERP; QEEG; ICA
• Other Study ID Numbers: BrainProteins