ADDEarly Phase 1BrainProteinNCT01856686

Neurocognitive and Neurobiological Improvement in ADHD Children by Modification of Dietary Protein

A Early Phase 1 study testing BP22042013 and Low carbohydrate diet in people with ADD and ADHD, run by Spanish Foundation for Neurometrics Development at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 years
Conditions the study is for: ADD, ADHD
What is being tested?: BP22042013 and Low carbohydrate diet
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteUnited Kingdom
Study dates: Dec 2013to Jul 2014
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
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

Show all 10Show fewer

suprarenal diseases
cancer
Brain injury
Cardiovascular or arrhythmia problems

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

New Remedies
Liverpool, Merseyside, L1 0AH

Other trials in United Kingdom

About this study

Read the 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.

Conditions: ADD, ADHD
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 groups in NCT01856686
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.

Reaction Time at 3 Months
Reaction time during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months

Secondary outcomes (9)

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.
Measured: 3 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2013Jul 2014

First posted17 May 2013 (estimated)
Study startDec 2013
Primary completionJun 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01856686
Sponsor's protocol ID: Brain Proteins
Acronym: BrainProtein
Status last verified: May 2024
First submitted: 14 May 2013
Last updated: 8 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All ADD trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2024. 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: NCT01856686
Acronym / sponsor ID: BrainProtein / Brain Proteins
Conditions: ADD, ADHD
Keywords: ADD, ADHD, Proteins, Dietary, Nutrition, QEEG, ERP, ICA
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Spanish Foundation for Neurometrics DevelopmentUniversity, hospital or other
Collaborators: PronoKal Foundation, Child Health Foundation
Study start: Dec 2013
Primary completion: Jun 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 17 May 2013 (estimated)
Results: Posted 10 Sep 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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: Not 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

Reaction Time at 3 Months
Time frame: 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
Time frame: 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
Time frame: 3 months
comission errors during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.(Test duration: 22 minutes)
Occipital Alpha Brainwaves Amplitudes at 3 Months
Time frame: 3 months
occipital alpha waves amplitudes during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Mu Waves-amplitude at 3 Months
Time frame: 3 months
Mu waves-amplitude during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.
Frontal Midline Theta Activity- Amplitude at 3 Months
Time frame: 3 months
Frontal midline theta activity- amplitude during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.

9 secondary outcomes

Occipital Alpha Waves-frequency at 3 Months
Time frame: 3 months
Parietal Alpha Waves-frequency at 3 Months
Time frame: 3 months
Mu Wave Frequency at 3 Months
Time frame: 3 months
Frontal Midline Theta Activity- Frequency at 3 Months
Time frame: 3 months
Monastra Ratio at 3 Months
Time frame: 3 months
Behavior
Time frame: 3 months
Hyperactivity Score
Time frame: 3 months
Impulsivity Score
Time frame: 3 months
Inattention Score
Time frame: 3 months

Results and safety

Results posted to the registry on 10 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BP22042013	31	26
Low Carbohydrate Diet	33	22

Primary outcome: Reaction Time at 3 Months

Time frame: 3 months. Mean (Standard Deviation). Unit: milliseconds

Measure	BP22042013 n = 26	Low Carbohydrate Diet n = 22
Value	506.58 (108.72)	510.59 (99.05)

BP22042013 vs Low Carbohydrate Diet: p = 0.56593, ANCOVA
BP22042013: p = 0.44929, Paired t-test
Low Carbohydrate Diet: p = 0.81844, Paired t-test

Primary outcome: Omission Errors at 3 Months

Time frame: 3 months. Mean (Standard Deviation). Unit: errors

Measure	BP22042013 n = 26	Low Carbohydrate Diet n = 22
Value	17.15 (19.54)	14.95 (13.43)

BP22042013 vs Low Carbohydrate Diet: p = 0.71152, ANCOVA
BP22042013: p = 0.27795, Paired t-test
Low Carbohydrate Diet: p = 0.47616, Paired t-test

Primary outcome: Comission Errors at 3 Months

Time frame: 3 months. Mean (Standard Deviation). Unit: errors

Measure	BP22042013 n = 26	Low Carbohydrate Diet n = 22
Value	2.19 (3.38)	2.82 (4.05)

BP22042013 vs Low Carbohydrate Diet: p = 0.10036, ANCOVA
BP22042013: p = 0.00820, Paired t-test
Low Carbohydrate Diet: p = 1.00000, Paired t-test

Primary outcome: Occipital Alpha Brainwaves Amplitudes at 3 Months

Time frame: 3 months. Mean (Standard Deviation). Unit: microvolts

Measure	BP22042013 n = 26	Low Carbohydrate Diet n = 22
Value	12.25 (9.89)	11.99 (11.24)

BP22042013 vs Low Carbohydrate Diet: p = 0.08946, ANCOVA
BP22042013: p = 0.27795, Paired t-test
Low Carbohydrate Diet: p = 0.01090, Paired t-test

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BP22042013	0 of 26 (0%)	0 of 26 (0%)	Not reported
Low Carbohydrate Diet	0 of 22 (0%)	0 of 22 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Brainmech FoundationLink provided by the sponsor.

Related trials for ADD

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RecruitingPhase 2
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Multiple Sclerosis
Recruiting
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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.

Moises Aguilar-Domingo, PhD principal investigator

Spanish Foundation for Neurometrics Development

1 site in 1 country: see every site and its status.

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 at 1 site in United Kingdom.

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 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 10 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Reaction Time at 3 Months (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01856686.

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 May 2024.