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

Attention Deficit Hyperactivity Disorder Clinical Trial

— AOE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807299
• Other study ID #: ADHD_Omega_Exercise
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: May 2015

Study information

• Verified date: February 2020
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 2015
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 7 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Dietary Supplement:
• Omega 3
Capsules of omega 3, 1000mg / capsules. Administered 3 times a day.

Other:
• Physical Training

Locations

Country	Name	City	State
Brazil	Departamento de Psicobiologia	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conners Scale	Scores on the Conners scale. Scores above 60 indicate ADHD. Minimum 0 and a maximum of 126.	3 months