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

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ClinicalTrials.gov Identifier: NCT01807299
Recruitment Status : Completed
First Posted : March 8, 2013
Results First Posted : February 28, 2020
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Jose Carlos Fernandes Galduroz MD, Federal University of São Paulo

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

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Dietary Supplement: Omega 3 Other: Physical Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Physical Training and the Omega 3 Consumption on Attention Deficit
Study Start Date : May 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : May 2015


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.

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



Primary Outcome Measures :
  1. Conners Scale [ Time Frame: 3 months ]
    Scores on the Conners scale. Scores above 60 indicate ADHD. Minimum 0 and a maximum of 126.



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Ages Eligible for Study:   7 Years to 14 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01807299


Locations
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Brazil
Departamento de Psicobiologia
São Paulo, Brazil, 04024002
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Principal Investigator: José Carlos F Galduróz, Md PhD Universidade Federal de São Paulo (UNIFESP)
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Responsible Party: Jose Carlos Fernandes Galduroz MD, Principal Investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01807299    
Other Study ID Numbers: ADHD_Omega_Exercise
First Posted: March 8, 2013    Key Record Dates
Results First Posted: February 28, 2020
Last Update Posted: February 28, 2020
Last Verified: February 2020
Keywords provided by Jose Carlos Fernandes Galduroz MD, Federal University of São Paulo:
Physical Training
ADHD-Attention deficit hyperactivity disorder
Omega 3
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms