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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01856686
Other study ID # Brain Proteins
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
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
Health authority
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

Study Design


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
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