Neurocognitive and Neurobiological Improvement in ADHD Children With High Protein Diet

Early Phase 1

Completed

• Conditions: ADD; ADHD
• Interventions: Dietary Supplement: Low carbohydrate diet; Drug: BP22042013

• Registration Number: NCT02614599
• Lead Sponsor: Spanish Foundation for Neurometrics Development

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.

Study Timeline

• Study First Submitted: 2013-04-22
• Study Start: 2015-06
• Status Verified: 2015-11
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Study First Submitted QC: 2015-11-21
• Study First Posted: 2015-11-25
• Last Update Submitted: 2021-04-07
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low carbohydrate Diet	Low carbohydrate diet	the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
BP22042013	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.

Primary Outcome Measures

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

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