Omega-3 Supplementation and Behavior Problems
|ClinicalTrials.gov Identifier: NCT02334098|
Recruitment Status : Unknown
Verified June 2015 by Dr. Annis Fung, City University of Hong Kong.
Recruitment status was: Recruiting
First Posted : January 8, 2015
Last Update Posted : June 9, 2015
The objectives of this project are as follows:
- To assess whether omega-3 dietary supplementation for six months can reduce externalizing behavior problems (antisocial and aggressive behavior) in schoolchildren aged 8 to 18, both at the end of treatment and six months post-treatment
- To assess whether omega-3 supplementation can enhance cognitive and brain functioning as measured both by neurocognitive and psychophysiological measures
- To assess whether any improvements in cognitive and brain functioning can help account for any improvements in behavior.
|Condition or disease||Intervention/treatment||Phase|
|Aggression Antisocial Behavior Attention Problems Anxiety||Dietary Supplement: Omega-3 supplemented drink Dietary Supplement: Smartfish||Phase 2 Phase 3|
Externalizing behavior problems (aggressive and antisocial behaviors) are widely recognized as predisposing to significant mental health problems and violence among adolescents in secondary schools. These in turn result in enormous economic and social costs to schools as well as to society. These costs include mental illness, crime, and violence. Similarly, violence is widely recognized as a major public health problem which has also largely defied successful intervention and prevention. Because an increasing body of research is documenting health and neurobiological risk factors for aggression and violence, part of this prevention failure may be due to intervention efforts ignoring biological contributory factors which include impaired neurocognitive and psychophysiological functioning. One benign biological intervention that may help attenuate behavior problems in children consists of omega-3 supplementation of the diet, a long-chain fatty acid critical for brain structure and function.
The overarching aim of this study is to assess whether omega-3 supplementation can reduce the base level of externalizing behavior problems in children and adolescents. Secondary but important aims are to assess whether any behavioral improvement is due to enhanced neurocognitive and psychophysiological functioning produced by omega-3 supplementation, and also whether there are changes in internalizing behavior problems..
The specific aims are as follows:
- To assess the effectiveness of omega-3 dietary supplementation in reducing externalizing behaviors in adolescents.
- To assess whether omega-3 supplementation can enhance childhood neurocognitive and psychophysiological functioning.
- To assess whether any such enhanced neurocognitive functioning mediates the relationship between omega-3 enhancement and reductions in externalizing behavior.
Hypotheses will be tested in a placebo-controlled, double-blind, randomized trial involving 8 to18 year-old adolescents drawn from primary and secondary schools in Hong Kong. Omega-3 supplementation will be in the form of a Norwegian fruit juice drink. 300 adolescents will be randomly assigned into: (1) omega-3 supplemented drink, (2) placebo drink, (3) treatment-as-usual controls. Behavioral, neurocognitive, and psychophysiological measures will be assessed at baseline (0 months), end of treatment (6 months), and 6 months post-treatment (12 months).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Omega-3 Supplementation and Behavior Problems in Children and Adolescents|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Omega-3 supplemented drink
A 200 ml. drink product with 1.1 grams of omega-3 from Smartfish (Smartfish: Forsiden in Norway).
Dietary Supplement: Omega-3 supplemented drink
The drink has apple/ pear/ pomegranate taste which is well accepted by children and adolescents, is rich in natural antioxidants to help prevent oxidation of omega-3. The drink can be taken at any time during the day.
1/3 of the participants will be assigned to the omega-3 group after randomization. They are going to take the treatment for 6 months. They will be assessed at baseline, end of treatment and 6 months post-treatment.
Placebo Comparator: Placebo Drink
exactly the same fruit drink contained in the same packaging, but will contain no omega-3.
Dietary Supplement: Smartfish
Treatment duration is 6 months. They will be assessed at baseline (0 months), end of treatment (6 months) and 6 months post-treatment (12 months).
No Intervention: treatment-as-usual controls
No drinks are taken.
- Externalizing and internalizing behavior problems [ Time Frame: up to 12 months after initiation of trial: assessement at 0 months, 6 months (end of treatment) and 12 months (6 months post-tretament) ]
The following instruments will be administered to both caregivers and the children to assess child behavior behavior problems (externalizing and internalizing)
Adolescent self-reported measures include Reactive-Proactive Aggression Questionnaire (RPQ), Antisocial Personality Screening Device (APSD), Conduct and Oppositional Defiant Disorder Questionnaire (COD) and Child Behavior Checklist (CBCL - Attention and Anxiety/Depressed subscales only).
- Neurocognitive functioning [ Time Frame: up to 12 months ]Neurocognitive functioning is assessed by the Tower of London. The Tower of London is an assessment tool to examine the functional anatomy of planning. It assesses high-order problem solving, specifically, executive planning abilities.
- Psychophysiological functioning [ Time Frame: up to 12 months ]Psychophysiological (attentional) functioning is assessed using EEG (P300 oddball task).
- Emotional empathy [ Time Frame: up to 12 months ]measured by a 10-items self-report instrument (CASES)
- Grit [ Time Frame: up to 12 months ]measured by an 8-item self-report instruments (GRIT)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334098
|Contact: Annis Fung, Ph.D.||(852)firstname.lastname@example.org|
|Contact: Adrian Raine, D.Phil.||email@example.com|
|City University of Hong Kong||Recruiting|
|Hong Kong, China|
|Contact: Annis Fung, Ph.D. (852)34422923 firstname.lastname@example.org|
|Contact: Chris Sin, BA (852)34422923 email@example.com|
|Principal Investigator:||Annis Fung, Ph.D.||City University of Hong Kong|