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

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: NCT01856686
• Other study ID #: Brain Proteins
• Status: Completed
• Phase: Early Phase 1
• Start date: December 2013
• Est. completion date: July 2014

Study information

• Verified date: May 2024
• 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• 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
• Attention Deficit Disorder with Hyperactivity

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
United Kingdom	New Remedies	Liverpool	Merseyside

Sponsors (3)

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight at 3 Months	Weight after 3 months of dietary approach.	3 months
Other	Body Mass Index at 3 Months	Body mass index after 3 months of dietary approach.	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	Up to 8 months
Primary	Reaction Time at 3 Months	Reaction time during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.	3 months
Primary	Omission Errors at 3 Months	Omission errors during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. (Test duration: 22 minutes)	3 months
Primary	Comission Errors at 3 Months	comission errors during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.(Test duration: 22 minutes)	3 months
Primary	Occipital Alpha Brainwaves Amplitudes at 3 Months	occipital alpha waves amplitudes during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.	3 months
Primary	Mu Waves-amplitude at 3 Months	Mu waves-amplitude during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.	3 months
Primary	Frontal Midline Theta Activity- Amplitude at 3 Months	Frontal midline theta activity- amplitude during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.	3 months
Secondary	Occipital Alpha Waves-frequency at 3 Months	occipital alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.	3 months
Secondary	Parietal Alpha Waves-frequency at 3 Months	Parietal alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.	3 months
Secondary	Mu Wave Frequency at 3 Months	Mu wave frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.	3 months
Secondary	Frontal Midline Theta Activity- Frequency at 3 Months	Frontal midline theta activity- frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.	3 months
Secondary	Monastra Ratio at 3 Months	Monastra ratio during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.	3 months
Secondary	Behavior	Behavior assessed by total score of clinical questionnaire (sum of Hyperactivity, Impulsivity and Inattention scores), after 3 months of nutritional approach.; Range: minimum value: 0 and maximum value: 25. Higher values represent a worse outcome.	3 months
Secondary	Hyperactivity Score	Hyperactivity assessed by clinical questionnaire after 3 months of nutritional approach. Range: minimum value: 0 and maximum value: 8. Higher values represent a worse outcome.	3 months
Secondary	Impulsivity Score	Impulsivity assessed by clinical questionnaire after 3 months of nutritional approach. Range: minimum value: 0 and maximum value: 8. Higher values represent a worse outcome.	3 months
Secondary	Inattention Score	Inattention assessed by clinical questionnaire after 3 months of nutritional approach. Range: minimum value: 0 and maximum value: 9. Higher values represent a worse outcome.	3 months

External Links

•   Brainmech Foundation
•   Pronokal Foundation