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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Spanish Foundation for Neurometrics Development
Sponsor:
Collaborators:
Pronokal Foundation
Children Healtdh Foundation
Information provided by (Responsible Party):
Spanish Foundation for Neurometrics Development
ClinicalTrials.gov Identifier:
NCT01856686
First received: May 14, 2013
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
ADD
ADHD
Drug: BP22042013
Dietary Supplement: Low carbohydrate diet
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Neurocognitive and Neurobiological Improvement in ADHD Children by Modification of Dietary Protein

Resource links provided by NLM:


Further study details as provided by Spanish Foundation for Neurometrics Development:

Primary Outcome Measures:
  • Changes from Baseline in reaction time at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Evaluate changes in reaction time during visual continuous performance task from 19 channels EEG recordings, before begin nutritional measures and after 3 months of dietary approach.

  • Changes from Baseline in omission errors at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Evaluate changes in omission errors during visual continuous performance task from 19 channels EEG recordings, before begin nutritional measures and after 3 months of dietary approach.

  • Changes from Baseline in comission errors at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Evaluate changes in comission errors during visual continuous performance task from 19 channels EEG recordings, before begin nutritional measures and after 3 months of dietary approach.

  • Changes from Baseline in latencies at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Evaluate changes in latencies during visual continuous performance task from 19 channels EEG recordings, before begin nutritional measures and after 3 months of dietary approach.

  • Changes from Baseline in amplitudes in brainwaves at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Evaluate changes in amplitudes in brainwaves during visual continuous performance task from 19 channels EEG recordings, before begin nutritional measures and after 3 months of dietary approach.


Secondary Outcome Measures:
  • Quantitative Electroencephalogram [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Analysis frequencies and amplitudes of brainwaves and spectral independent components before and after 3 months of nutritional intervention

  • Behavior [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Evaluate Behavior with clinical scales (AMEN questionnaire) at the beginning and after 3 months of nutritional approach.


Other Outcome Measures:
  • Change in Weight [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Change from Baseline in Weight after 3 months of nutritional intervention

  • Change in body mass index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Change in body mass index after 3 months of nutritional intervention.

  • Change in body composition [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Change in body composition using bioelectrical impedance after 3 months of nutritional intervention.

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 8 months ] [ Designated as safety issue: Yes ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability of Brain Proteins Supplements


Estimated Enrollment: 100
Study Start Date: December 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.
Other Name: Brain Proteins Supplements
Experimental: Low carbohydrate Diet
the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
Dietary Supplement: Low carbohydrate diet
the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements
Other Name: 2000 Kilo-calories without Fast Absorbing Carbohydrate

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.

  Eligibility

Ages Eligible for Study:   7 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01856686

Contacts
Contact: Moises Aguilar-Domingo, PhD +34 634 541 729 moises.aguilar@gmail.com
Contact: Fernando Vargas-Torcal, PhD +34 966 661 529 patronato@fundacionsaludinfantil.org

Locations
Spain
Pronokal Foundation Recruiting
Barcelona, Spain, 08009
Contact: Moises Aguilar-Domingo, PhD    +34 634 541 729    moises.aguilar@gmail.com   
Contact: Fernando Vargas-Torcal, PhD    +34 966 661 529    patronato@fundacionsaludinfantil.org   
Principal Investigator: Moises Aguilar-Domingo, PhD         
Sub-Investigator: Fernando Vargas-Torcal, PhD         
Sponsors and Collaborators
Spanish Foundation for Neurometrics Development
Pronokal Foundation
Children Healtdh Foundation
Investigators
Principal Investigator: Moises Aguilar-Domingo, PhD Spanish Foundation for Neurometrics Development
  More Information

Additional Information:
No publications provided

Responsible Party: Spanish Foundation for Neurometrics Development
ClinicalTrials.gov Identifier: NCT01856686     History of Changes
Other Study ID Numbers: Brain Proteins
Study First Received: May 14, 2013
Last Updated: December 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Spanish Foundation for Neurometrics Development:
ADD
ADHD
Proteins
Dietary
Nutrition
QEEG
ERP
ICA

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014