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| Name | Class |
|---|---|
| PronoKal Foundation | OTHER |
| Child Health Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BP22042013 | Experimental | 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. |
|
| Low carbohydrate Diet | Experimental | the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BP22042013 | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative Electroencephalogram | Analysis frequencies and amplitudes of brainwaves and spectral independent components before and after 3 months of nutritional intervention | 3 months |
| Behavior |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | Change from Baseline in Weight after 3 months of nutritional intervention | 3 months |
| Change in body mass index | Change in body mass index after 3 months of nutritional intervention. |
Inclusion Criteria:
Exclusion Criteria:
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| Label | URL |
|---|---|
| Brainmech Foundation | View source |
| Neurometrics | View source |
| Children Health Foundation | View source |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Low carbohydrate diet | Dietary Supplement | the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements |
|
|
Evaluate Behavior with clinical scales (AMEN questionnaire) at the beginning and after 3 months of nutritional approach.
| 3 months |
| 3 months |
| Change in body composition | Change in body composition using bioelectrical impedance after 3 months of nutritional intervention. | 3 months |
| 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 |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |