The Effect of Physical Training and the Omega 3 Consumption on Attention Deficit Hyperactivity Disorder in Children (AOE)

The Effect of Physical Training and the Omega 3 Consumption on Attention Deficit

The attention deficit hyperactivity disorder (ADHD) usually occurs in preschool and may cause disabilities through whole life.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Dietary supplement: Omega 3; Other: Physical Training

Detailed Description

The attention deficit hyperactivity disorder (ADHD) usually occurs in preschool and may cause disabilities through whole life. The treatment of this disease is expensive and difficult. Moreover, physical exercise and omegas consumption may improve the cognitive functions and behavior, so it could be an interesting strategy to improve this disorder. The aim of the present study is to verify the effects of multiple components physical training and the consumption of omega 3 on behavior, cognitive functions and the serum levels of BDNF and IGF-1 in ADHD children. Thus, 68 ADHD children, between seven and fourteen years old will be selected. The volunteers will be randomly divided into four groups: Physical Training Group (PTG), Omega Group (OG), Omega and Physical Training Group (OPTG) and Control Group (CG). The protocol of the experiment will last three months in which the OPTG will make physical training and receive fish oil capsules, and the PTG will make only the physical training and receive a placebo of fish oil. The others groups will be oriented not to make any type of physical training, but the OG will receive fish oil capsule, and the CG will receive a placebo of fish oil. Behavioral and cognitive functions evaluations and blood analysis will be made at the beginning and at the end of the protocol.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04024002
    • Departamento de Psicobiologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Children with ADHD: male, between seven and fourteen years old, sedentary, studing in a regular school.

Exclusion Criteria:

• Taking psychoactive medications, taking omega supplement.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical Training; The training group will make physical exercise for three months (three times a week).	Dietary supplement: Omega 3; Capsules of omega 3, 1000mg / capsules. Administered 3 times a day.
Other: Sedentary; The sedentary group will be oriented not to make any type of physical training for three months.	Dietary supplement: Omega 3; Capsules of omega 3, 1000mg / capsules. Administered 3 times a day.
Placebo Comparator: Placebo; The omega 3 group will receive 2g per day of mineral oil during 90 days treatment	Other: Physical Training
Experimental: Omega 3; The omega 3 group will receive 2g per day of fish oil during 90 days treatment	Other: Physical Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conners Scale	Scores on the Conners scale. Scores above 60 indicate ADHD. Minimum 0 and a maximum of 126.	3 months

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Principal Investigator: José Carlos F Galduróz, Md PhD, Universidade Federal de São Paulo (UNIFESP)

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: March 7, 2013
• First Submitted That Met QC Criteria: March 7, 2013
• First Posted (Estimate): March 8, 2013

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 17, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Omega 3; Physical Training; ADHD-Attention deficit hyperactivity disorder
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: ADHD_Omega_Exercise