Effects of Omega-3 Fatty Acids Supplementation on Brain and Behaviour in Healthy Children.

NCT02346773 | Completed

• 1 other identifier: UNottingham
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Behaviour

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Cognitive assessment as measured by neuropsychological testing

  Change from baseline cognitive assessment at 3 months

Study Arms (2)

ω-3 LC-PUFA group

ACTIVE COMPARATOR

The intervention product was a full fat (80%) margarine. The active intervention product contained 590 mg docosahexaenoic acid (DHA) and 650 mg eicosapentaenoic acid (EPA) per 10-g daily serving.

Dietary Supplement: ω-3 LC-PUFA

Placebo group

PLACEBO COMPARATOR

The placebo product was a similar margarine with the same sensory properties, but with monounsaturated fatty acids (MUFA; refined plant oils) replacing EPA and DHA; total saturated fatty acids (SAFA) and ω-6 long chain polyunsaturated fatty acids (LC-PUFA) content were similar between the active and placebo products.

Other: Placebo

Interventions

ω-3 LC-PUFA DIETARY_SUPPLEMENT

The intervention product was a full fat (80%) margarine.Participants were provided with one-month supply of the intervention product (including reserve products) at the onset of the intervention and received a new supply monthly. The intervention products were provided in neutral serving-sized cups, each containing 10 grams of margarine.The child's parents were instructed to have their child consume one complete portion pack (10 g) of margarine per day. The margarine had to be consumed as spread on sandwiches, crackers or bread rolls.The intervention product could be consumed on various periods over the day or all at one occasion. Every day a new portion pack had to be used, even if there was margarine left in the package of the previous day.

ω-3 LC-PUFA group

Placebo OTHER

The placebo product was a similar margarine with the same sensory properties, but with monounsaturated fatty acids (MUFA; refined plant oils) replacing EPA and DHA; total saturated fatty acids (SAFA) and ω-6 long chain polyunsaturated fatty acids (LC-PUFA) content were similar between the active and placebo products.

Placebo group

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \) eating fatty fish/shellfish more than once a week;
• \) using ω-3 and/or ω-6 LC-PUFA supplements more than once a week;
• \) consuming products fortified with ω-3 LC-PUFA (EPA and/or DHA \>100 mg/day) in the three months prior to study participation;
• \) positive history of alcohol abuse during pregnancy;
• \) positive history of malignancy and heart disease requiring heart surgery;
• \) Premature birth (\< 35 weeks) and/or detached placenta
• \) Hyperbilirubinemia requiring transfusion
• \) severe mental illness (e.g. autism, schizophrenia) or mental retardation;
• \) MRI contraindications
• \) Type 1 diabetes
• \) Epilepsy
• \) Brain tumour
• \) Head trauma with loss of consciousness \>30 minutes
• \) Muscular dystrophy, myotonic dystrophy
• \) Nutritional and metabolic diseases (e.g. failure to thrive, phenylketonuria)

Sponsors & Collaborators

• University of Nottingham: lead
• Unilever R&D: collaborator

Study Sites (1)

Brain and Body Centre, School of Psychology, University of Nottingham

Nottingham, NG7 2RD, United Kingdom

Location

MeSH Terms

Conditions

Behavior

Study Officials

• Tomáš Paus, M.D., Ph.D.

  Rotman Research Institute, University of Toronto, Toronto, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: January 27, 2015
• Study Start: November 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 9, 2015

Record last verified: 2015-12

Locations

GB (1)