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
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.
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
No
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 |
|---|---|---|
| Occipital Alpha Brainwaves Amplitudes at 3 Months | 3 months | occipital alpha waves amplitudes during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. |
| Frontal Midline Theta Activity- Amplitude at 3 Months | 3 months | Frontal midline theta activity- amplitude during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. |
| Mu Waves-amplitude at 3 Months | 3 months | Mu waves-amplitude during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. |
| Reaction Time at 3 Months | 3 months | Reaction time during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. |
| Omission Errors at 3 Months | 3 months | Omission errors during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. (Test duration: 22 minutes) |
| Comission Errors at 3 Months | 3 months | comission errors during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.(Test duration: 22 minutes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Behavior | 3 months | 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. |
| Impulsivity Score | 3 months | 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. |
| Inattention Score | 3 months | 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. |
| Hyperactivity Score | 3 months | 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. |
| Occipital Alpha Waves-frequency at 3 Months | 3 months | occipital alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. |
| Parietal Alpha Waves-frequency at 3 Months | 3 months | Parietal alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. |
| Mu Wave Frequency at 3 Months | 3 months | Mu wave frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. |
| Frontal Midline Theta Activity- Frequency at 3 Months | 3 months | Frontal midline theta activity- frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. |
| Monastra Ratio at 3 Months | 3 months | Monastra ratio during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Up to 8 months | Number of Participants with Adverse Events as a Measure of Safety and Tolerability of Brain Proteins Supplements |
| Body Mass Index at 3 Months | 3 months | Body mass index after 3 months of dietary approach. |
| Weight at 3 Months | 3 months | Weight after 3 months of dietary approach. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 26 |
| 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 | 22 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 11 |
Baseline characteristics
| Characteristic | Low Carbohydrate Diet | BP22042013 | Total |
|---|---|---|---|
| Age, Continuous | 9.41 years STANDARD_DEVIATION 1.87 | 9.08 years STANDARD_DEVIATION 1.9 | 9.23 years STANDARD_DEVIATION 1.87 |
| Behavior (clinical scale) | 16.55 units on a scale STANDARD_DEVIATION 5.76 | 15.88 units on a scale STANDARD_DEVIATION 4.95 | 16.19 units on a scale STANDARD_DEVIATION 5.29 |
| Body mass index | 18.77 kg/m2 STANDARD_DEVIATION 3.66 | 16.16 kg/m2 STANDARD_DEVIATION 2.87 | 17.36 kg/m2 STANDARD_DEVIATION 3.48 |
| Comission errors | 2.82 errors STANDARD_DEVIATION 2.79 | 4.58 errors STANDARD_DEVIATION 6.3 | 3.77 errors STANDARD_DEVIATION 5.04 |
| Frontal midline theta activity- amplitude | 11.66 microvolts STANDARD_DEVIATION 8.17 | 8.08 microvolts STANDARD_DEVIATION 5.87 | 9.72 microvolts STANDARD_DEVIATION 7.17 |
| Frontal midline theta activity- frequency | 4.88 Hertz STANDARD_DEVIATION 1.4 | 4.69 Hertz STANDARD_DEVIATION 1.13 | 4.78 Hertz STANDARD_DEVIATION 1.25 |
| Hyperactivity score (clinical scale) | 3.82 units on a scale STANDARD_DEVIATION 2.67 | 3.62 units on a scale STANDARD_DEVIATION 2.59 | 3.71 units on a scale STANDARD_DEVIATION 2.6 |
| Impulsivity score (clinical scale) | 4.82 units on a scale STANDARD_DEVIATION 2.74 | 4.58 units on a scale STANDARD_DEVIATION 2.42 | 4.69 units on a scale STANDARD_DEVIATION 2.54 |
| Inattention score (clinical score) | 7.91 units on a scale STANDARD_DEVIATION 1.6 | 7.69 units on a scale STANDARD_DEVIATION 1.52 | 7.79 units on a scale STANDARD_DEVIATION 1.54 |
| Monastra ratio | 25.14 ratio STANDARD_DEVIATION 9.72 | 22.15 ratio STANDARD_DEVIATION 8.75 | 23.52 ratio STANDARD_DEVIATION 9.23 |
| Mu wave frequency | 9.09 Hertz STANDARD_DEVIATION 1.06 | 9.07 Hertz STANDARD_DEVIATION 1.22 | 9.08 Hertz STANDARD_DEVIATION 1.14 |
| Mu waves-amplitude | 7.87 microvolts STANDARD_DEVIATION 8.09 | 7.38 microvolts STANDARD_DEVIATION 6.77 | 7.60 microvolts STANDARD_DEVIATION 7.33 |
| Occipital alpha waves-amplitude | 20.56 microvolts STANDARD_DEVIATION 17.02 | 15.75 microvolts STANDARD_DEVIATION 10.45 | 17.95 microvolts STANDARD_DEVIATION 13.9 |
| Occipital alpha waves-frequency | 9.48 Hz STANDARD_DEVIATION 0.99 | 9.62 Hz STANDARD_DEVIATION 1.02 | 9.55 Hz STANDARD_DEVIATION 1 |
| Omission errors | 18.00 errors STANDARD_DEVIATION 15.39 | 19.31 errors STANDARD_DEVIATION 20.69 | 18.71 errors STANDARD_DEVIATION 18.28 |
| Parietal alpha waves-frequency | 9.12 Hertz STANDARD_DEVIATION 0.94 | 8.72 Hertz STANDARD_DEVIATION 1.04 | 8.91 Hertz STANDARD_DEVIATION 1 |
| Reaction time | 506.59 milliseconds STANDARD_DEVIATION 65.74 | 520.46 milliseconds STANDARD_DEVIATION 93.27 | 514.10 milliseconds STANDARD_DEVIATION 81.28 |
| Sex: Female, Male Female | 8 Participants | 10 Participants | 18 Participants |
| Sex: Female, Male Male | 14 Participants | 16 Participants | 30 Participants |
| weight | 38.15 Kilograms STANDARD_DEVIATION 11.36 | 30.09 Kilograms STANDARD_DEVIATION 7.66 | 33.78 Kilograms STANDARD_DEVIATION 10.26 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 22 |
| serious Total, serious adverse events | 0 / 26 | 0 / 22 |
Outcome results
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)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BP22042013 | Comission Errors at 3 Months | 2.19 errors | Standard Deviation 3.38 |
| Low Carbohydrate Diet | Comission Errors at 3 Months | 2.82 errors | Standard Deviation 4.05 |
Comparison: Between-Group Comparisonp-value: 0.10036ANCOVA
Comparison: Within-group changesp-value: 0.0082Paired t-test
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 1Paired t-test
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BP22042013 | Frontal Midline Theta Activity- Amplitude at 3 Months | 6.81 microvolts | Standard Deviation 3.62 |
| Low Carbohydrate Diet | Frontal Midline Theta Activity- Amplitude at 3 Months | 9.13 microvolts | Standard Deviation 7.3 |
Comparison: Between-Group Comparisonp-value: 0.39707ANCOVA
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.27945Paired t-test
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.19739Paired t-test
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BP22042013 | Mu Waves-amplitude at 3 Months | 6.32 microvolts | Standard Deviation 6.38 |
| Low Carbohydrate Diet | Mu Waves-amplitude at 3 Months | 6.05 microvolts | Standard Deviation 5.59 |
Comparison: Between-Group Comparisonp-value: 0.05158ANCOVA
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.94574Paired t-test
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.09331Paired t-test
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BP22042013 | Occipital Alpha Brainwaves Amplitudes at 3 Months | 12.25 microvolts | Standard Deviation 9.89 |
| Low Carbohydrate Diet | Occipital Alpha Brainwaves Amplitudes at 3 Months | 11.99 microvolts | Standard Deviation 11.24 |
Comparison: Between-Group Comparisonp-value: 0.08946ANCOVA
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.27795Paired t-test
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.0109Paired t-test
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)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BP22042013 | Omission Errors at 3 Months | 17.15 errors | Standard Deviation 19.54 |
| Low Carbohydrate Diet | Omission Errors at 3 Months | 14.95 errors | Standard Deviation 13.43 |
Comparison: Between-Group Comparisonp-value: 0.71152ANCOVA
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.27795Paired t-test
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.47616Paired t-test
Primary
Reaction Time at 3 Months
Reaction time during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BP22042013 | Reaction Time at 3 Months | 506.58 milliseconds | Standard Deviation 108.72 |
| Low Carbohydrate Diet | Reaction Time at 3 Months | 510.59 milliseconds | Standard Deviation 99.05 |
Comparison: Between-Group Comparisonp-value: 0.56593ANCOVA
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.44929Paired t-test
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.81844Paired t-test
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BP22042013 | Behavior | 13.08 units on a scale | Standard Deviation 5.11 |
| Low Carbohydrate Diet | Behavior | 12.45 units on a scale | Standard Deviation 5.87 |
Comparison: Between-Group Comparisonp-value: 0.50964ANCOVA
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.0071Paired t-test
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.00595Paired t-test
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BP22042013 | Frontal Midline Theta Activity- Frequency at 3 Months | 4.70 Hz | Standard Deviation 1.38 |
| Low Carbohydrate Diet | Frontal Midline Theta Activity- Frequency at 3 Months | 4.76 Hz | Standard Deviation 1.3 |
Comparison: Between-Group Comparisonp-value: 0.83929ANCOVA
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.97213Paired t-test
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.58323Paired t-test
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BP22042013 | Hyperactivity Score | 3.04 units on a scale | Standard Deviation 2.39 |
| Low Carbohydrate Diet | Hyperactivity Score | 2.68 units on a scale | Standard Deviation 2.25 |
Comparison: Between-Group Comparisonp-value: 0.45013ANCOVA
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.17374Paired t-test
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.07548Paired t-test
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BP22042013 | Impulsivity Score | 3.96 units on a scale | Standard Deviation 2.16 |
| Low Carbohydrate Diet | Impulsivity Score | 3.55 units on a scale | Standard Deviation 2.22 |
Comparison: Between-Group Comparisonp-value: 0.23226ANCOVA
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.08812Paired t-test
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.00776Pairedt-test
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BP22042013 | Inattention Score | 6.08 units on a scale | Standard Deviation 2.5 |
| Low Carbohydrate Diet | Inattention Score | 6.23 units on a scale | Standard Deviation 2.43 |
Comparison: Between-Group Comparisonp-value: 0.90843ANCOVA
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.00413Paired t-test
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.00775Paired t-test
Secondary
Monastra Ratio at 3 Months
Monastra ratio during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BP22042013 | Monastra Ratio at 3 Months | 16.88 ratio | Standard Deviation 9.84 |
| Low Carbohydrate Diet | Monastra Ratio at 3 Months | 22.36 ratio | Standard Deviation 11.27 |
Comparison: Between-Group Comparisonp-value: 0.17383ANCOVA
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.00092Paired t-test
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.15544Paired t-test
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BP22042013 | Mu Wave Frequency at 3 Months | 9.06 Hz | Standard Deviation 1.13 |
| Low Carbohydrate Diet | Mu Wave Frequency at 3 Months | 9.07 Hz | Standard Deviation 1.17 |
Comparison: Between-Group Comparisonp-value: 0.94449ANCOVA
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.94574Paired t-test
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.85428Paired t-test
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BP22042013 | Occipital Alpha Waves-frequency at 3 Months | 9.71 Hz | Standard Deviation 1.13 |
| Low Carbohydrate Diet | Occipital Alpha Waves-frequency at 3 Months | 9.60 Hz | Standard Deviation 1.24 |
Comparison: Between-Group Comparisonp-value: 0.92193ANCOVA
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.50704Paired t-test
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.42314Paired t-test
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BP22042013 | Parietal Alpha Waves-frequency at 3 Months | 8.96 Hz | Standard Deviation 1.09 |
| Low Carbohydrate Diet | Parietal Alpha Waves-frequency at 3 Months | 9.21 Hz | Standard Deviation 1.07 |
Comparison: Between-Group Comparisonp-value: 0.73209ANCOVA
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.07965Paired t-test
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.61613Paired t-test
Other Pre-specified
Body Mass Index at 3 Months
Body mass index after 3 months of dietary approach.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BP22042013 | Body Mass Index at 3 Months | 16.50 kg/m2 | Standard Deviation 2.54 |
| Low Carbohydrate Diet | Body Mass Index at 3 Months | 18.55 kg/m2 | Standard Deviation 3.43 |
Comparison: Between-Group Comparisonp-value: 0.48336ANCOVA
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.08739Paired t-test
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.37046Paired t-test
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
Time frame: Up to 8 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BP22042013 | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 0 participants |
| Low Carbohydrate Diet | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 0 participants |
Other Pre-specified
Weight at 3 Months
Weight after 3 months of dietary approach.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BP22042013 | Weight at 3 Months | 31.59 kilograms | Standard Deviation 7.28 |
| Low Carbohydrate Diet | Weight at 3 Months | 38.67 kilograms | Standard Deviation 11.18 |
Comparison: Between-Group Comparisonp-value: 0.33027ANCOVA
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.00013Paired t-test
Comparison: Within-group comparisons between the baseline and 3 month datap-value: 0.28019Paired t-test