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

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Dietary Supplement: Omega 3; Other: Physical Training

• Registration Number: NCT01807299
• Lead Sponsor: Federal University of São Paulo

Brief Summary

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

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 Timeline

• Study Start: 2011-05
• Primary Completion: 2013-03
• Study First Submitted: 2013-03-07
• Study First Submitted QC: 2013-03-07
• Study First Posted: 2013-03-08
• Study Completion: 2015-05
• Results First Submitted: 2019-02-13
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-17
• Last Update Submitted: 2020-02-17
• Results First Posted: 2020-02-28
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sedentary	Omega 3	The sedentary group will be oriented not to make any type of physical training for three months.
Omega 3	Physical Training	The omega 3 group will receive 2g per day of fish oil during 90 days treatment
Placebo	Physical Training	The omega 3 group will receive 2g per day of mineral oil during 90 days treatment
Physical Training	Omega 3	The training group will make physical exercise for three months (three times a week).

Primary Outcome Measures

Name	Time	Method
Conners Scale	3 months	Scores on the Conners scale. Scores above 60 indicate ADHD. Minimum 0 and a maximum of 126.

Trial Locations

Locations (1)

Departamento de Psicobiologia; 🇧🇷 São Paulo, Brazil