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

Overview

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

Full Title of Study: “The Effect of Physical Training and the Omega 3 Consumption on Attention Deficit”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: March 2013

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.

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 7 Years

Maximum Age: 14 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Federal University of São Paulo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jose Carlos Fernandes Galduroz MD, Principal Investigator – Federal University of São Paulo
  • Overall Official(s)
    • José Carlos F Galduróz, Md PhD, Principal Investigator, Universidade Federal de São Paulo (UNIFESP)

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