Neurocognitive and Neurobiological Improvement in ADHD Children With High Protein Diet

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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ADD ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

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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

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Brain Proteins Supplements 2000 Kilo-calories without Fast Absorbing Carbohydrate

Eligibility Criteria

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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

Yes