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

NCT01856686 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-05-08

Study results available
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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

Interventions

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.

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

Sponsors & Collaborators

  • PronoKal Foundation

    collaborator OTHER

  • Child Health Foundation

    collaborator OTHER

  • Spanish Foundation for Neurometrics Development

    lead OTHER

Principal Investigators

  • Moises Aguilar-Domingo, PhD · Spanish Foundation for Neurometrics Development

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-06-30
Completion
2014-07-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01856686 on ClinicalTrials.gov