ADDEarly Phase 1BrainProteinNCT02614599
Neurocognitive and Neurobiological Improvement in ADHD Children With High Protein Diet
A Early Phase 1 study testing BP22042013 and Low carbohydrate diet in people with ADD and ADHD, run by Spanish Foundation for Neurometrics Development.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- What is being tested?
- BP22042013 and Low carbohydrate diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Nov 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- eating disorders
- psychosis, bipolar disorder or depression
- kidney or liver failure
- diabetes
- diuretic or cortisone treatment
- haematological problems
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- suprarenal diseases
- cancer
- Brain injury
- Cardiovascular or arrhythmia problems
About this study
Official title: Neurocognitive and Neurobiological Improvement in ADHD Children by Modification of Dietary Protein
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.
Read the detailed description
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.
- Being tested
- BP22042013, Low carbohydrate diet
- Keywords
- ADD, ADHD, Proteins, Dietary, Nutrition, QEEG, ERP, ICA
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BP22042013Drug
Also called Brain Proteins Supplements
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 dietDietary supplement
Also called 2000 Kilo-calories without Fast Absorbing Carbohydrate
the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: BP22042013 |
| Low carbohydrate Diet | Experimental | the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements Receives: Dietary Supplement: Low carbohydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
Quantitative Electroencephalogram
Analysis frequencies and amplitudes of brainwaves and spectral independent components before and after 3 months of nutritional intervention
Measured: 3 months
Behavior
Evaluate Behavior with clinical scales (AMEN questionnaire) at the beginning and after 3 months of nutritional approach.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startJun 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spanish Foundation for Neurometrics Development
- Sponsor type
- University, hospital or other
- Collaborators
- PronoKal Foundation, Child Health Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614599
- Sponsor's protocol ID
- BrainProteins
- Acronym
- BrainProtein
- Status last verified
- Nov 2015
- First submitted
- 22 Apr 2013
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive and Neurobiological Improvement in ADHD Children by Modification of Dietary Protein
- ClinicalTrials.gov ID
- NCT02614599
- Acronym / sponsor ID
- BrainProtein / BrainProteins
- Keywords
- ADD, ADHD, Proteins, Dietary, Nutrition, QEEG, ERP, ICA
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Spanish Foundation for Neurometrics DevelopmentUniversity, hospital or other
- Collaborators
- PronoKal Foundation, Child Health Foundation
- Study start
- Jun 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BP22042013 | Experimental | Drug: BP22042013This 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 | Dietary Supplement: Low carbohydrate dietthe second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- eating disorders
- psychosis, bipolar disorder or depression
- kidney or liver failure
- diabetes
- diuretic or cortisone treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BP22042013Also: Brain Proteins SupplementsThis 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. | Drug | BP22042013 |
| Low carbohydrate dietAlso: 2000 Kilo-calories without Fast Absorbing Carbohydratethe second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements | Dietary supplement | Low carbohydrate Diet |
Primary outcome
Changes Related Potential Recording after 3 months of dietary approach
Time frame: 3 months
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.
2 secondary outcomes
Quantitative Electroencephalogram
Time frame: 3 months
Behavior
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Brainmech FoundationLink provided by the sponsor.
- NeurometricsLink provided by the sponsor.
- Children Health FoundationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BP22042013 and Low carbohydrate diet in people with ADD and ADHD, run by Spanish Foundation for Neurometrics Development.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes Related Potential Recording after 3 months of dietary approach (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.