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The attention deficit hyperactivity disorder (ADHD) usually occurs in preschool and may cause disabilities through whole life.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Training | Experimental | The training group will make physical exercise for three months (three times a week). |
|
| Sedentary | Other | The sedentary group will be oriented not to make any type of physical training for three months. |
|
| Placebo | Placebo Comparator | The omega 3 group will receive 2g per day of mineral oil during 90 days treatment |
|
| Omega 3 | Experimental | The omega 3 group will receive 2g per day of fish oil during 90 days treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega 3 | Dietary Supplement | Capsules of omega 3, 1000mg / capsules. Administered 3 times a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Conners Scale | Scores on the Conners scale. Scores above 60 indicate ADHD. Minimum 0 and a maximum of 126. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Carlos F Galduróz, Md PhD | Universidade Federal de São Paulo (UNIFESP) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departamento de Psicobiologia | São Paulo | 04024002 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37058600 | Derived | Gillies D, Leach MJ, Perez Algorta G. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD007986. doi: 10.1002/14651858.CD007986.pub3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Omega-3 | Take Omega-3 Only |
| FG001 | Sedentary (Control) | The sedentary group will be oriented not to make any type of physical training for three months. |
| FG002 | Placebo + Physical Training | The omega 3 group will receive 2g per day of mineral oil during 90 days treatment Physical Training |
| FG003 | Omega 3 + Physical Training | The omega 3 group will receive 2g per day of fish oil during 90 days treatment Physical Training |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omega-3 Only | Omega 3: Capsules of omega 3, 1000mg / capsules. Administered 3 times a day. |
| BG001 | Sedentary (Control) | The sedentary group will be oriented not to make any type of physical training for three months. Omega 3: Capsules of omega 3, 1000mg / capsules. Administered 3 times a day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Conners Scale | Scores on the Conners scale. Scores above 60 indicate ADHD. Minimum 0 and a maximum of 126. | Conners scale and the child stress scale (ESI) | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omega-3 Only | Omega 3: Capsules of omega 3, 1000mg / capsules. Administered 3 times a day. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PhD José Carlos F. Galduróz | Universidade Federal de São Paulo | galduroz@unifesp.br |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D064797 | Physical Conditioning, Human |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| Physical Training | Other |
|
| BG002 | Placebo + Phsycal Training | The omega 3 group will receive 2g per day of mineral oil during 90 days treatment Physical Training |
| BG003 | Omega 3 + Phsycal Training | The omega 3 group will receive 2g per day of fish oil during 90 days treatment Physical Training |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
The omega 3 group will receive 2g per day of mineral oil during 90 days treatment Physical Training |
| OG003 | Omega 3 + Phsycal Training | The omega 3 group will receive 2g per day of fish oil during 90 days treatment Physical Training |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Sedentary (Control) | The sedentary group will be oriented not to make any type of physical training for three months. | 0 | 14 | 0 | 14 |
| EG002 | Placebo + Phsycal Training | The omega 3 group will receive 2g per day of mineral oil during 90 days treatment Physical Training | 0 | 12 | 0 | 12 |
| EG003 | Omega 3 + Phsycal Training | The omega 3 group will receive 2g per day of fish oil during 90 days treatment Physical Training | 0 | 13 | 0 | 13 |
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| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |