ADD, ADHD
Conditions
Keywords
ADD, ADHD, Proteins, Dietary, Nutrition, QEEG, ERP, ICA
Brief 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
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.
Interventions
DRUGBP22042013
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_SUPPLEMENTLow carbohydrate diet
the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements
Sponsors
PronoKal Foundation
Child Health Foundation
Spanish Foundation for Neurometrics Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
7 Years to 13 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes Related Potential Recording after 3 months of dietary approach | 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
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Electroencephalogram | 3 months | Analysis frequencies and amplitudes of brainwaves and spectral independent components before and after 3 months of nutritional intervention |
| Behavior | 3 months | Evaluate Behavior with clinical scales (AMEN questionnaire) at the beginning and after 3 months of nutritional approach. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight | 3 months | Change from Baseline in Weight after 3 months of nutritional intervention |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | From April to December 2013 | Number of Participants with Adverse Events as a Measure of Safety and Tolerability of Brain Proteins Supplements |
| Change in body mass index | 3 months | Change in body mass index after 3 months of nutritional intervention. |
| Change in body composition | 3 months | Change in body composition using bioelectrical impedance after 3 months of nutritional intervention. |
Outcome results
None listed