Neurocognitive and Neurobiological Improvement in ADHD Children With High Protein Diet (BrainProtein)
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|ClinicalTrials.gov Identifier: NCT02614599|
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : April 8, 2021
Spanish Foundation for Neurometrics Development
Child Health Foundation
Information provided by (Responsible Party):
Spanish Foundation for Neurometrics Development
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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.
|Condition or disease||Intervention/treatment||Phase|
|ADD ADHD||Drug: BP22042013 Dietary Supplement: Low carbohydrate diet||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Neurocognitive and Neurobiological Improvement in ADHD Children by Modification of Dietary Protein|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
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.
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.
Other Name: Brain Proteins Supplements
Experimental: Low carbohydrate Diet
the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
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
Other Name: 2000 Kilo-calories without Fast Absorbing Carbohydrate
Primary Outcome Measures :
- Changes Related Potential Recording after 3 months of dietary approach [ Time Frame: 3 months ]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.
Secondary Outcome Measures :
- Quantitative Electroencephalogram [ Time Frame: 3 months ]Analysis frequencies and amplitudes of brainwaves and spectral independent components before and after 3 months of nutritional intervention
- Behavior [ Time Frame: 3 months ]Evaluate Behavior with clinical scales (AMEN questionnaire) at the beginning and after 3 months of nutritional approach.
Other Outcome Measures:
- Change in Weight [ Time Frame: 3 months ]Change from Baseline in Weight after 3 months of nutritional intervention
- Change in body mass index [ Time Frame: 3 months ]Change in body mass index after 3 months of nutritional intervention.
- Change in body composition [ Time Frame: 3 months ]Change in body composition using bioelectrical impedance after 3 months of nutritional intervention.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: From April to December 2013 ]Number of Participants with Adverse Events as a Measure of Safety and Tolerability of Brain Proteins Supplements
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|Ages Eligible for Study:||7 Years to 13 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
- eating disorders
- psychosis, bipolar disorder or depression
- kidney or liver failure
- diuretic or cortisone treatment
- haematological problems
- suprarenal diseases
- Brain injury
- Cardiovascular or arrhythmia problems
No Contacts or Locations Provided
|Responsible Party:||Spanish Foundation for Neurometrics Development|
|Other Study ID Numbers:||
|First Posted:||November 25, 2015 Key Record Dates|
|Last Update Posted:||April 8, 2021|
|Last Verified:||November 2015|
Keywords provided by Spanish Foundation for Neurometrics Development: