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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.
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.
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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 |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Parietal Alpha Waves-frequency at 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight at 3 Months | Weight after 3 months of dietary approach. | 3 months |
| Body Mass Index at 3 Months | Body mass index after 3 months of dietary approach. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moises Aguilar-Domingo, PhD | Spanish Foundation for Neurometrics Development | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Remedies | Liverpool | Merseyside | L1 0AH | United Kingdom |
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| Label | URL |
|---|---|
| Brainmech Foundation | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | BP22042013 | 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. |
| FG001 | Low Carbohydrate Diet | This group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All patients without Electroencephalogram recordings at 3 months were excluded from statistical analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | BP22042013 | 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. 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reaction Time at 3 Months | Reaction time during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. | Posted | Mean | Standard Deviation | milliseconds | 3 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BP22042013 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Moises Aguilar Domingo | Spanish Foundation for Neurometrics Development | +441615312645 | moises@bigdata4brain.co.uk |
| 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 |
|
|
Parietal alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
| 3 months |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | Up to 8 months |
| Low Carbohydrate Diet |
the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Reaction time | Reaction time during visual continuous performance task from 19 channels EEG recordings | Mean | Standard Deviation | milliseconds |
|
| Omission errors | omission errors during visual continuous performance task from 19 channels EEG recordings (test duration 22 minutes) | Mean | Standard Deviation | errors |
|
| Comission errors | Comission errors during visual continuous performance task from 19 channels EEG recordings (test duration 22 minutes) | Mean | Standard Deviation | errors |
|
| Occipital alpha waves-frequency | Frequency Occipital alpha waves during visual continuous performance task | Mean | Standard Deviation | Hz |
|
| Occipital alpha waves-amplitude | Amplitude of occipital alpha waves during visual continuous performance task | Mean | Standard Deviation | microvolts |
|
| Parietal alpha waves-frequency | Frequency of Parietal alpha waves during visual continuous performance task | Mean | Standard Deviation | Hertz |
|
| Mu wave frequency | Frequency mu waves during visual continuous performance task | Mean | Standard Deviation | Hertz |
|
| Mu waves-amplitude | Amplitude of mu waves during visual continuous performance task | Mean | Standard Deviation | microvolts |
|
| Frontal midline theta activity- frequency | Mean | Standard Deviation | Hertz |
|
| Frontal midline theta activity- amplitude | Mean | Standard Deviation | microvolts |
|
| Monastra ratio | Theta wave/ Beta wave ratio | Mean | Standard Deviation | ratio |
|
| weight | Mean | Standard Deviation | Kilograms |
|
| Body mass index | Mean | Standard Deviation | kg/m2 |
|
| Hyperactivity score (clinical scale) | Hyperactivity score from clinical questionnaire. Range: minimum value: 0 and maximum value: 8. Higher values represent a worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Impulsivity score (clinical scale) | Impulsivity score from clinical questionnaire. Range: minimum value: 0 and maximum value: 8. Higher values represent a worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Inattention score (clinical score) | Inattention score from clinical questionnaire. Range: minimum value: 0 and maximum value: 9. Higher values represent a worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Behavior (clinical scale) | Behavior assessed by total score of clinical questionnaire (sum of Hyperactivity, Impulsivity and Inattention scores). Range: minimum value: 0 and maximum value: 25. Higher values represent a worse outcome. | Mean | Standard Deviation | units on a scale |
|
|
|
|
| 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) | Posted | Mean | Standard Deviation | errors | 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) | Posted | Mean | Standard Deviation | errors | 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. | Posted | Mean | Standard Deviation | Hz | 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. | Posted | Mean | Standard Deviation | microvolts | 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. | Posted | Mean | Standard Deviation | Hz | 3 months |
|
|
|
|
| Other Pre-specified | Weight at 3 Months | Weight after 3 months of dietary approach. | Posted | Mean | Standard Deviation | kilograms | 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. | Posted | Mean | Standard Deviation | Hz | 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. | Posted | Mean | Standard Deviation | Hz | 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. | Posted | Mean | Standard Deviation | microvolts | 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. | Posted | Mean | Standard Deviation | ratio | 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. | Posted | Mean | Standard Deviation | microvolts | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
|
| Other Pre-specified | Body Mass Index at 3 Months | Body mass index after 3 months of dietary approach. | Posted | Mean | Standard Deviation | kg/m2 | 3 months |
|
|
|
|
| Other Pre-specified | 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 | Posted | Number | participants | Up to 8 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. | Posted | Mean | Standard Deviation | units on a scale | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Low Carbohydrate Diet | the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements | 0 | 22 | 0 | 22 |
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| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| 0.27795 |
| Superiority or Other (legacy) |
| Within-group comparisons between the baseline and 3 month data | Paired t-test | 0.47616 | Superiority or Other (legacy) |
| 0.00820 |
| Superiority or Other (legacy) |
| Within-group comparisons between the baseline and 3 month data | Paired t-test | 1.00000 | Superiority or Other (legacy) |
| 0.50704 |
| Superiority or Other (legacy) |
| Within-group comparisons between the baseline and 3 month data | Paired t-test | 0.42314 | Superiority or Other (legacy) |
| 0.27795 |
| Superiority or Other (legacy) |
| Within-group comparisons between the baseline and 3 month data | Paired t-test | 0.01090 | Superiority or Other (legacy) |
| 0.07965 |
| Superiority or Other (legacy) |
| Within-group comparisons between the baseline and 3 month data | Paired t-test | 0.61613 | Superiority or Other (legacy) |
| 0.00013 |
| Superiority or Other (legacy) |
| Within-group comparisons between the baseline and 3 month data | Paired t-test | 0.28019 | Superiority or Other (legacy) |
| 0.94574 |
| Superiority or Other (legacy) |
| Within-group comparisons between the baseline and 3 month data | Paired t-test | 0.85428 | Superiority or Other (legacy) |
| 0.97213 |
| Superiority or Other (legacy) |
| Within-group comparisons between the baseline and 3 month data | Paired t-test | 0.58323 | Superiority or Other (legacy) |
| 0.94574 |
| Superiority or Other (legacy) |
| Within-group comparisons between the baseline and 3 month data | Paired t-test | 0.09331 | Superiority or Other (legacy) |
| 0.00092 |
| Superiority or Other (legacy) |
| Within-group comparisons between the baseline and 3 month data | Paired t-test | 0.15544 | Superiority or Other (legacy) |
| 0.27945 |
| Superiority or Other (legacy) |
| Within-group comparisons between the baseline and 3 month data | Paired t-test | 0.19739 | Superiority or Other (legacy) |
| 0.00710 |
| Superiority or Other (legacy) |
| Within-group comparisons between the baseline and 3 month data | Paired t-test | 0.00595 | Superiority or Other (legacy) |
| 0.08739 |
| Superiority or Other (legacy) |
| Within-group comparisons between the baseline and 3 month data | Paired t-test | 0.37046 | Superiority or Other (legacy) |
| 0.17374 |
| Superiority or Other (legacy) |
| Within-group comparisons between the baseline and 3 month data | Paired t-test | 0.07548 | Superiority or Other (legacy) |
| 0.08812 |
| Superiority or Other (legacy) |
| Within-group comparisons between the baseline and 3 month data | Pairedt-test | 0.00776 | Superiority or Other (legacy) |
| 0.00413 |
| Superiority or Other (legacy) |
| Within-group comparisons between the baseline and 3 month data | Paired t-test | 0.00775 | Superiority or Other (legacy) |