Neurocognitive and Neurobiological Improvement in ADHD Children With High Protein Diet

ADHD Clinical Trial

— BrainProtein  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02614599
• Other study ID #: BrainProteins
• Status: Completed
• Phase: Early Phase 1
• Start date: June 2015
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Spanish Foundation for Neurometrics Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• ADD
• ADHD

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Spanish Foundation for Neurometrics Development	Child Health Foundation, PronoKal Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Weight	Change from Baseline in Weight after 3 months of nutritional intervention	3 months
Other	Change in body mass index	Change in body mass index after 3 months of nutritional intervention.	3 months
Other	Change in body composition	Change in body composition using bioelectrical impedance after 3 months of nutritional intervention.	3 months
Other	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
Primary	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	Quantitative Electroencephalogram	Analysis frequencies and amplitudes of brainwaves and spectral independent components before and after 3 months of nutritional intervention	3 months
Secondary	Behavior	Evaluate Behavior with clinical scales (AMEN questionnaire) at the beginning and after 3 months of nutritional approach.	3 months

External Links

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