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Neurocognitive and Neurobiological Improvement in ADHD Children With High Protein Diet (BrainProtein)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02614599
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : November 25, 2015
Sponsor:
Collaborators:
PronoKal Foundation
Child Health Foundation
Information provided by (Responsible Party):
Spanish Foundation for Neurometrics Development

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.

Condition or disease Intervention/treatment Phase
ADD ADHD Drug: BP22042013 Dietary Supplement: Low carbohydrate diet Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Neurocognitive and Neurobiological Improvement in ADHD Children by Modification of Dietary Protein
Study Start Date : June 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Quantitative Electroencephalogram [ Time Frame: 3 months ]
    Analysis frequencies and amplitudes of brainwaves and spectral independent components before and after 3 months of nutritional intervention

  2. Behavior [ Time Frame: 3 months ]
    Evaluate Behavior with clinical scales (AMEN questionnaire) at the beginning and after 3 months of nutritional approach.


Other Outcome Measures:
  1. Change in Weight [ Time Frame: 3 months ]
    Change from Baseline in Weight after 3 months of nutritional intervention

  2. Change in body mass index [ Time Frame: 3 months ]
    Change in body mass index after 3 months of nutritional intervention.

  3. Change in body composition [ Time Frame: 3 months ]
    Change in body composition using bioelectrical impedance after 3 months of nutritional intervention.

  4. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: From April to December 2013 ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability of Brain Proteins Supplements



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Ages Eligible for Study:   7 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614599


Locations
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Spain
Pronokal Foundation
Barcelona, Spain, 08009
Sponsors and Collaborators
Spanish Foundation for Neurometrics Development
PronoKal Foundation
Child Health Foundation
Investigators
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Principal Investigator: Moises Aguilar-Domingo, PhD Spanish Foundation for Neurometrics Development
Additional Information:
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Responsible Party: Spanish Foundation for Neurometrics Development
ClinicalTrials.gov Identifier: NCT02614599    
Other Study ID Numbers: BrainProteins
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: November 25, 2015
Last Verified: November 2015
Keywords provided by Spanish Foundation for Neurometrics Development:
ADD
ADHD
Proteins
Dietary
Nutrition
QEEG
ERP
ICA