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

Spanish Foundation for Neurometrics Development

Status and phase: Completed; Early Phase 1

Conditions: ADD; ADHD

Treatments: Drug: BP22042013; Dietary Supplement: Low carbohydrate diet

Study type: Interventional

Funder types: Other

Identifiers

NCT01856686

Brain Proteins

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 7 to 13 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

BP22042013

Experimental group

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.

Treatment:

Drug: BP22042013

Low carbohydrate Diet

Experimental group

Description:

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

Treatment:

Dietary Supplement: Low carbohydrate diet