Neurocognitive and Neurobiological Improvement in ADHD Children With High Protein Diet
BrainProtein
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jun 2015
Shorter than P25 for early_phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2013
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedFirst Posted
Study publicly available on registry
November 25, 2015
CompletedApril 8, 2021
November 1, 2015
5 months
April 22, 2013
April 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Quantitative Electroencephalogram
3 months
Behavior
3 months
Other Outcomes (4)
Change in Weight
3 months
Change in body mass index
3 months
Change in body composition
3 months
- +1 more other outcomes
Study Arms (2)
BP22042013
EXPERIMENTALThis 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
EXPERIMENTALthe second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
Interventions
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.
the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Spanish Foundation for Neurometrics Developmentlead
- PronoKal Foundationcollaborator
- Child Health Foundationcollaborator
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2013
First Posted
November 25, 2015
Study Start
June 1, 2015
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
April 8, 2021
Record last verified: 2015-11