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

NCT01856686 | Completed Early Phase 1 Results DMC

• 1 other identifier: Brain Proteins
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

ADD; ADHD

Keywords

ADD; ADHD; Proteins; Dietary; Nutrition; QEEG; ERP; ICA

Outcome Measures

Primary Outcomes (6)

• Reaction Time at 3 Months

  Reaction time during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.

  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)

  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)

  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.

  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.

  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.

  3 months

Secondary Outcomes (9)

• Occipital Alpha Waves-frequency at 3 Months

  3 months

• Parietal Alpha Waves-frequency at 3 Months

  3 months

• Mu Wave Frequency at 3 Months

  3 months

• Frontal Midline Theta Activity- Frequency at 3 Months

  3 months

• Monastra Ratio at 3 Months

  3 months

Other Outcomes (3)

• Weight at 3 Months

  3 months

• Body Mass Index at 3 Months

  3 months

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  Up to 8 months

Study Arms (2)

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.

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

Dietary Supplement: Low carbohydrate diet

Interventions

BP22042013 DRUG

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.

Also known as: Brain Proteins Supplements

BP22042013

Low carbohydrate diet DIETARY_SUPPLEMENT

the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements

Also known as: 2000 Kilo-calories without Fast Absorbing Carbohydrate

Low carbohydrate Diet

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spanish Foundation for Neurometrics Development: lead
• PronoKal Foundation: collaborator
• Child Health Foundation: collaborator

Study Sites (1)

New Remedies

Liverpool, Merseyside, L1 0AH, United Kingdom

Location

Related Links

• Brainmech Foundation

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Dr. Moises Aguilar Domingo
• Organization: Spanish Foundation for Neurometrics Development

moises@bigdata4brain.co.uk

+441615312645

Study Officials

• Moises Aguilar-Domingo, PhD

  Spanish Foundation for Neurometrics Development

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 17, 2013
• Study Start: December 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: May 8, 2024
• Results First Posted: September 10, 2014

Record last verified: 2024-05

Locations

GB (1)