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

This study has been completed.
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: August 30, 2014
Last verified: August 2014
  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:
  • Reaction Time at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Frontal midline theta activity- amplitude during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.


Secondary Outcome Measures:
  • Occipital Alpha Waves-frequency at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    occipital alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.

  • Parietal Alpha Waves-frequency at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Parietal alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.

  • Mu Wave Frequency at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Mu wave frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.

  • Frontal Midline Theta Activity- Frequency at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Frontal midline theta activity- frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.

  • Monastra Ratio at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Monastra ratio during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.

  • Behavior [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

    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.


  • Hyperactivity Score [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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.

  • Impulsivity Score [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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.

  • Inattention Score [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • Weight at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Weight after 3 months of dietary approach.

  • Body Mass Index at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Body mass index after 3 months of dietary approach.

  • 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


Enrollment: 64
Study Start Date: December 2013
Study Completion Date: July 2014
Primary Completion Date: June 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:   No
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

Locations
Spain
Pronokal Foundation
Barcelona, Spain, 08009
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
Results First Received: July 21, 2014
Last Updated: August 30, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 28, 2014