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Clinical Trials/NCT01807299
NCT01807299CompletedNot Applicable

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

Federal University of São Paulo2 sites in 1 country68 target enrollmentStarted: May 1, 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
68
Locations
2
Primary Endpoint
Conners Scale

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
7 Years to 14 Years (Child)
Sex
Male
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Conners Scale

Time Frame: 3 months

Scores on the Conners scale. Scores above 60 indicate ADHD. Minimum 0 and a maximum of 126.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Federal University of São Paulo
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jose Carlos Fernandes Galduroz MD

Principal Investigator

Federal University of São Paulo

Study Sites (2)

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