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

• ClinicalTrials.gov Identifier: NCT02614599
• Recruitment Status: Completed
• First Posted: November 25, 2015
• Last Update Posted: April 8, 2021
• Sponsor: Spanish Foundation for Neurometrics Development
• Collaborators: PronoKal Foundation; Child Health Foundation
• Information provided by (Responsible Party): Spanish Foundation for Neurometrics Development

Tracking Information

• First Submitted Date: April 22, 2013
• First Posted Date: November 25, 2015
• Last Update Posted Date: April 8, 2021
• Study Start Date: June 2015
• Actual Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 21, 2015)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 21, 2015)

• Quantitative Electroencephalogram [ Time Frame: 3 months ]
  Analysis frequencies and amplitudes of brainwaves and spectral independent components before and after 3 months of nutritional intervention
• Behavior [ Time Frame: 3 months ]
  Evaluate Behavior with clinical scales (AMEN questionnaire) at the beginning and after 3 months of nutritional approach.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: November 21, 2015)

• Change in Weight [ Time Frame: 3 months ]
  Change from Baseline in Weight after 3 months of nutritional intervention
• Change in body mass index [ Time Frame: 3 months ]
  Change in body mass index after 3 months of nutritional intervention.
• Change in body composition [ Time Frame: 3 months ]
  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: From April to December 2013 ]
  Number of Participants with Adverse Events as a Measure of Safety and Tolerability of Brain Proteins Supplements

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Neurocognitive and Neurobiological Improvement in ADHD Children With High Protein Diet
• Official Title: Neurocognitive and Neurobiological Improvement in ADHD Children by Modification of Dietary Protein
• 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.
• 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 Type: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Supportive Care

Condition

• ADD
• ADHD

Intervention

• 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
• 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

Study Arms

• 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.
  Intervention: Drug: BP22042013
• Experimental: Low carbohydrate Diet
  the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
  Intervention: Dietary Supplement: Low carbohydrate diet

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: November 21, 2015): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 2015
• Actual Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 7 Years to 13 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: Spain

Administrative Information

• NCT Number: NCT02614599
• Other Study ID Numbers: BrainProteins
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Spanish Foundation for Neurometrics Development
• Original Responsible Party: Same as current
• Current Study Sponsor: Spanish Foundation for Neurometrics Development
• Original Study Sponsor: Same as current

Collaborators

• PronoKal Foundation
• Child Health Foundation

• Investigators: Not Provided
• PRS Account: Spanish Foundation for Neurometrics Development
• Verification Date: November 2015