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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Neurocognitive and Neurobiological Improvement in ADHD Children With High Protein Diet

NCT02614599

ADD ADHD

COMPLETED EARLY_PHASE1

Biomarker Research in ADHD: the Impact of Nutrition

NCT03440346

Attention Deficit-Hyperactivity Disorder

COMPLETED NA

Low-dose vs. Normal-dose Psychostimulants on Executive Functions in Individuals With ADHD

NCT02167048

Attention Deficit Hyperactivity Disorders

ACTIVE_NOT_RECRUITING PHASE1/PHASE2

Identification of Biomarkers of Attention Deficit Disorder With or Without Hyperactivity (ADHD) by a Metabolomic Approach in Children

NCT03436017

Adhd

COMPLETED

Evaluating Clinical Outcomes of Treatment Effectiveness for Children and Adults With ADHD

NCT00307268

Attention-Deficit/Hyperactivity Disorder (ADHD)

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ADD ADHD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

BP22042013

Intervention Type 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.

Low carbohydrate Diet

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

Group Type EXPERIMENTAL

Low carbohydrate diet

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Low carbohydrate diet

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Brain Proteins Supplements 2000 Kilo-calories without Fast Absorbing Carbohydrate

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

7 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No