Behaviour Clinical Trial
Official title:
Effects of Omega-3 Fatty Acids Supplementation on Brain and Behaviour in Healthy Children.
Verified date | December 2015 |
Source | University of Nottingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Interventional |
Currently, there is considerable interest in the possibility that dietary supplementation with fatty acids, mostly omega-3 fatty acids, will have potential benefits for brain development. Epidemiological and clinical studies support the idea that relative disappearance of omega-3 diet from the diet in developed countries has been linked with increases in both physical and mental disorders. Omega-3 deficiency may lead to cognitive impairment, motor dysfunction and visual acuity problems. It is further known that families with lower socioeconomic status may have poorer diet and, consequently, may not realize their full potential regarding their cognitive abilities. The aim of this project is to evaluate effectiveness of a diet intervention rich in omega-3 acid in healthy children 9-to-12 years old from less well-off families.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 9 Years to 12 Years |
Eligibility |
Inclusion Criteria: - Child in target age (9-12 yrs) - Child native language English - Child is available for providing a blood sample - Child is available for MRI scan Exclusion Criteria: - 1) eating fatty fish/shellfish more than once a week; - 2) using ?-3 and/or ?-6 LC-PUFA supplements more than once a week; - 3) consuming products fortified with ?-3 LC-PUFA (EPA and/or DHA >100 mg/day) in the three months prior to study participation; - 4) positive history of alcohol abuse during pregnancy; - 5) positive history of malignancy and heart disease requiring heart surgery; - 6) Premature birth (< 35 weeks) and/or detached placenta - 7) Hyperbilirubinemia requiring transfusion - 8) severe mental illness (e.g. autism, schizophrenia) or mental retardation; - 9) MRI contraindications - 10) Type 1 diabetes - 11) Epilepsy - 12) Brain tumour - 13) Head trauma with loss of consciousness >30 minutes - 14) Muscular dystrophy, myotonic dystrophy - 15) Nutritional and metabolic diseases (e.g. failure to thrive, phenylketonuria) - 16) Hearing deficit (requiring hearing aid) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
Country | Name | City | State |
---|---|---|---|
United Kingdom | Brain and Body Centre, School of Psychology, University of Nottingham | Nottingham |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham | Unilever R&D |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Multi-modal Magnetic Resonance Imaging (MRI): Investigating the effects of three months of EPA&DHA supplementation on brain structure of healthy children 9-to-12 years old. | Change from baseline MRI measures (DTI, MTR, MRS) at 3 months | Yes | |
Secondary | Cognitive assessment as measured by neuropsychological testing | Neuropsychological testing: Intelligence Quotient (WISC-IV), Processing Speed (Trail Making Test), Selective & Sustained Attention (Ruff 2&7 Test), Working Memory (Self Ordered Pointing Test), Wisconsin Card Sorting Test | Change from baseline cognitive assessment at 3 months | No |
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