Trial Outcomes & Findings for Neurocognitive and Neurobiological Improvement in ADHD Children by Modification of Dietary Protein (NCT NCT01856686)
NCT ID: NCT01856686
Last Updated: 2024-05-08
Results Overview
Reaction time during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
64 participants
Primary outcome timeframe
3 months
Results posted on
2024-05-08
Participant Flow
Participant milestones
| Measure |
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.
|
Low Carbohydrate Diet
This group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
33
|
|
Overall Study
COMPLETED
|
26
|
22
|
|
Overall Study
NOT COMPLETED
|
5
|
11
|
Reasons for withdrawal
| Measure |
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.
|
Low Carbohydrate Diet
This group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
11
|
Baseline Characteristics
Neurocognitive and Neurobiological Improvement in ADHD Children by Modification of Dietary Protein
Baseline characteristics by cohort
| Measure |
BP22042013
n=26 Participants
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.
|
Low Carbohydrate Diet
n=22 Participants
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
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.08 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
9.41 years
STANDARD_DEVIATION 1.87 • n=7 Participants
|
9.23 years
STANDARD_DEVIATION 1.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Reaction time
|
520.46 milliseconds
STANDARD_DEVIATION 93.27 • n=5 Participants
|
506.59 milliseconds
STANDARD_DEVIATION 65.74 • n=7 Participants
|
514.10 milliseconds
STANDARD_DEVIATION 81.28 • n=5 Participants
|
|
Omission errors
|
19.31 errors
STANDARD_DEVIATION 20.69 • n=5 Participants
|
18.00 errors
STANDARD_DEVIATION 15.39 • n=7 Participants
|
18.71 errors
STANDARD_DEVIATION 18.28 • n=5 Participants
|
|
Comission errors
|
4.58 errors
STANDARD_DEVIATION 6.30 • n=5 Participants
|
2.82 errors
STANDARD_DEVIATION 2.79 • n=7 Participants
|
3.77 errors
STANDARD_DEVIATION 5.04 • n=5 Participants
|
|
Occipital alpha waves-frequency
|
9.62 Hz
STANDARD_DEVIATION 1.02 • n=5 Participants
|
9.48 Hz
STANDARD_DEVIATION 0.99 • n=7 Participants
|
9.55 Hz
STANDARD_DEVIATION 1.00 • n=5 Participants
|
|
Occipital alpha waves-amplitude
|
15.75 microvolts
STANDARD_DEVIATION 10.45 • n=5 Participants
|
20.56 microvolts
STANDARD_DEVIATION 17.02 • n=7 Participants
|
17.95 microvolts
STANDARD_DEVIATION 13.90 • n=5 Participants
|
|
Parietal alpha waves-frequency
|
8.72 Hertz
STANDARD_DEVIATION 1.04 • n=5 Participants
|
9.12 Hertz
STANDARD_DEVIATION 0.94 • n=7 Participants
|
8.91 Hertz
STANDARD_DEVIATION 1.00 • n=5 Participants
|
|
Mu wave frequency
|
9.07 Hertz
STANDARD_DEVIATION 1.22 • n=5 Participants
|
9.09 Hertz
STANDARD_DEVIATION 1.06 • n=7 Participants
|
9.08 Hertz
STANDARD_DEVIATION 1.14 • n=5 Participants
|
|
Mu waves-amplitude
|
7.38 microvolts
STANDARD_DEVIATION 6.77 • n=5 Participants
|
7.87 microvolts
STANDARD_DEVIATION 8.09 • n=7 Participants
|
7.60 microvolts
STANDARD_DEVIATION 7.33 • n=5 Participants
|
|
Frontal midline theta activity- frequency
|
4.69 Hertz
STANDARD_DEVIATION 1.13 • n=5 Participants
|
4.88 Hertz
STANDARD_DEVIATION 1.40 • n=7 Participants
|
4.78 Hertz
STANDARD_DEVIATION 1.25 • n=5 Participants
|
|
Frontal midline theta activity- amplitude
|
8.08 microvolts
STANDARD_DEVIATION 5.87 • n=5 Participants
|
11.66 microvolts
STANDARD_DEVIATION 8.17 • n=7 Participants
|
9.72 microvolts
STANDARD_DEVIATION 7.17 • n=5 Participants
|
|
Monastra ratio
|
22.15 ratio
STANDARD_DEVIATION 8.75 • n=5 Participants
|
25.14 ratio
STANDARD_DEVIATION 9.72 • n=7 Participants
|
23.52 ratio
STANDARD_DEVIATION 9.23 • n=5 Participants
|
|
weight
|
30.09 Kilograms
STANDARD_DEVIATION 7.66 • n=5 Participants
|
38.15 Kilograms
STANDARD_DEVIATION 11.36 • n=7 Participants
|
33.78 Kilograms
STANDARD_DEVIATION 10.26 • n=5 Participants
|
|
Body mass index
|
16.16 kg/m2
STANDARD_DEVIATION 2.87 • n=5 Participants
|
18.77 kg/m2
STANDARD_DEVIATION 3.66 • n=7 Participants
|
17.36 kg/m2
STANDARD_DEVIATION 3.48 • n=5 Participants
|
|
Hyperactivity score (clinical scale)
|
3.62 units on a scale
STANDARD_DEVIATION 2.59 • n=5 Participants
|
3.82 units on a scale
STANDARD_DEVIATION 2.67 • n=7 Participants
|
3.71 units on a scale
STANDARD_DEVIATION 2.60 • n=5 Participants
|
|
Impulsivity score (clinical scale)
|
4.58 units on a scale
STANDARD_DEVIATION 2.42 • n=5 Participants
|
4.82 units on a scale
STANDARD_DEVIATION 2.74 • n=7 Participants
|
4.69 units on a scale
STANDARD_DEVIATION 2.54 • n=5 Participants
|
|
Inattention score (clinical score)
|
7.69 units on a scale
STANDARD_DEVIATION 1.52 • n=5 Participants
|
7.91 units on a scale
STANDARD_DEVIATION 1.60 • n=7 Participants
|
7.79 units on a scale
STANDARD_DEVIATION 1.54 • n=5 Participants
|
|
Behavior (clinical scale)
|
15.88 units on a scale
STANDARD_DEVIATION 4.95 • n=5 Participants
|
16.55 units on a scale
STANDARD_DEVIATION 5.76 • n=7 Participants
|
16.19 units on a scale
STANDARD_DEVIATION 5.29 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsReaction time during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Outcome measures
| Measure |
BP22042013
n=26 Participants
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.
|
Low Carbohydrate Diet
n=22 Participants
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
|
|---|---|---|
|
Reaction Time at 3 Months
|
506.58 milliseconds
Standard Deviation 108.72
|
510.59 milliseconds
Standard Deviation 99.05
|
PRIMARY outcome
Timeframe: 3 monthsOmission errors during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. (Test duration: 22 minutes)
Outcome measures
| Measure |
BP22042013
n=26 Participants
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.
|
Low Carbohydrate Diet
n=22 Participants
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
|
|---|---|---|
|
Omission Errors at 3 Months
|
17.15 errors
Standard Deviation 19.54
|
14.95 errors
Standard Deviation 13.43
|
PRIMARY outcome
Timeframe: 3 monthscomission errors during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.(Test duration: 22 minutes)
Outcome measures
| Measure |
BP22042013
n=26 Participants
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.
|
Low Carbohydrate Diet
n=22 Participants
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
|
|---|---|---|
|
Comission Errors at 3 Months
|
2.19 errors
Standard Deviation 3.38
|
2.82 errors
Standard Deviation 4.05
|
PRIMARY outcome
Timeframe: 3 monthsoccipital alpha waves amplitudes during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Outcome measures
| Measure |
BP22042013
n=26 Participants
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.
|
Low Carbohydrate Diet
n=22 Participants
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
|
|---|---|---|
|
Occipital Alpha Brainwaves Amplitudes at 3 Months
|
12.25 microvolts
Standard Deviation 9.89
|
11.99 microvolts
Standard Deviation 11.24
|
PRIMARY outcome
Timeframe: 3 monthsMu waves-amplitude during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Outcome measures
| Measure |
BP22042013
n=26 Participants
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.
|
Low Carbohydrate Diet
n=22 Participants
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
|
|---|---|---|
|
Mu Waves-amplitude at 3 Months
|
6.32 microvolts
Standard Deviation 6.38
|
6.05 microvolts
Standard Deviation 5.59
|
PRIMARY outcome
Timeframe: 3 monthsFrontal midline theta activity- amplitude during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Outcome measures
| Measure |
BP22042013
n=26 Participants
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.
|
Low Carbohydrate Diet
n=22 Participants
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
|
|---|---|---|
|
Frontal Midline Theta Activity- Amplitude at 3 Months
|
6.81 microvolts
Standard Deviation 3.62
|
9.13 microvolts
Standard Deviation 7.30
|
SECONDARY outcome
Timeframe: 3 monthsoccipital alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Outcome measures
| Measure |
BP22042013
n=26 Participants
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.
|
Low Carbohydrate Diet
n=22 Participants
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
|
|---|---|---|
|
Occipital Alpha Waves-frequency at 3 Months
|
9.71 Hz
Standard Deviation 1.13
|
9.60 Hz
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: 3 monthsParietal alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Outcome measures
| Measure |
BP22042013
n=26 Participants
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.
|
Low Carbohydrate Diet
n=22 Participants
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
|
|---|---|---|
|
Parietal Alpha Waves-frequency at 3 Months
|
8.96 Hz
Standard Deviation 1.09
|
9.21 Hz
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: 3 monthsMu wave frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Outcome measures
| Measure |
BP22042013
n=26 Participants
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.
|
Low Carbohydrate Diet
n=22 Participants
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
|
|---|---|---|
|
Mu Wave Frequency at 3 Months
|
9.06 Hz
Standard Deviation 1.13
|
9.07 Hz
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: 3 monthsFrontal midline theta activity- frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Outcome measures
| Measure |
BP22042013
n=26 Participants
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.
|
Low Carbohydrate Diet
n=22 Participants
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
|
|---|---|---|
|
Frontal Midline Theta Activity- Frequency at 3 Months
|
4.70 Hz
Standard Deviation 1.38
|
4.76 Hz
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: 3 monthsMonastra ratio during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Outcome measures
| Measure |
BP22042013
n=26 Participants
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.
|
Low Carbohydrate Diet
n=22 Participants
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
|
|---|---|---|
|
Monastra Ratio at 3 Months
|
16.88 ratio
Standard Deviation 9.84
|
22.36 ratio
Standard Deviation 11.27
|
SECONDARY outcome
Timeframe: 3 monthsBehavior 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.
Outcome measures
| Measure |
BP22042013
n=26 Participants
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.
|
Low Carbohydrate Diet
n=22 Participants
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
|
|---|---|---|
|
Behavior
|
13.08 units on a scale
Standard Deviation 5.11
|
12.45 units on a scale
Standard Deviation 5.87
|
SECONDARY outcome
Timeframe: 3 monthsHyperactivity assessed by clinical questionnaire after 3 months of nutritional approach. Range: minimum value: 0 and maximum value: 8. Higher values represent a worse outcome.
Outcome measures
| Measure |
BP22042013
n=26 Participants
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.
|
Low Carbohydrate Diet
n=22 Participants
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
|
|---|---|---|
|
Hyperactivity Score
|
3.04 units on a scale
Standard Deviation 2.39
|
2.68 units on a scale
Standard Deviation 2.25
|
SECONDARY outcome
Timeframe: 3 monthsImpulsivity assessed by clinical questionnaire after 3 months of nutritional approach. Range: minimum value: 0 and maximum value: 8. Higher values represent a worse outcome.
Outcome measures
| Measure |
BP22042013
n=26 Participants
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.
|
Low Carbohydrate Diet
n=22 Participants
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
|
|---|---|---|
|
Impulsivity Score
|
3.96 units on a scale
Standard Deviation 2.16
|
3.55 units on a scale
Standard Deviation 2.22
|
SECONDARY outcome
Timeframe: 3 monthsInattention assessed by clinical questionnaire after 3 months of nutritional approach. Range: minimum value: 0 and maximum value: 9. Higher values represent a worse outcome.
Outcome measures
| Measure |
BP22042013
n=26 Participants
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.
|
Low Carbohydrate Diet
n=22 Participants
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
|
|---|---|---|
|
Inattention Score
|
6.08 units on a scale
Standard Deviation 2.50
|
6.23 units on a scale
Standard Deviation 2.43
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsWeight after 3 months of dietary approach.
Outcome measures
| Measure |
BP22042013
n=26 Participants
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.
|
Low Carbohydrate Diet
n=22 Participants
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
|
|---|---|---|
|
Weight at 3 Months
|
31.59 kilograms
Standard Deviation 7.28
|
38.67 kilograms
Standard Deviation 11.18
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsBody mass index after 3 months of dietary approach.
Outcome measures
| Measure |
BP22042013
n=26 Participants
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.
|
Low Carbohydrate Diet
n=22 Participants
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
|
|---|---|---|
|
Body Mass Index at 3 Months
|
16.50 kg/m2
Standard Deviation 2.54
|
18.55 kg/m2
Standard Deviation 3.43
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 8 monthsNumber of Participants with Adverse Events as a Measure of Safety and Tolerability of Brain Proteins Supplements
Outcome measures
| Measure |
BP22042013
n=26 Participants
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.
|
Low Carbohydrate Diet
n=22 Participants
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
|
|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
|
0 participants
|
0 participants
|
Adverse Events
BP22042013
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Carbohydrate Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Moises Aguilar Domingo
Spanish Foundation for Neurometrics Development
Phone: +441615312645
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place