NCT01856686

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Spanish Foundation for Neurometrics Development · Academic / Other
• Sex: All
• Age: 7 Years – 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ADD
• ADHD

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-06-01
• Completion: 2014-07-01
• First posted: 2013-05-17
• Last updated: 2024-05-08
• Results posted: 2014-09-10

Locations

1 site across 1 country: United Kingdom