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Omega-3 Supplementation and Behavior Problems

Primary Purpose

Aggression, Antisocial Behavior, Antisocial Personality

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Omega-3 supplemented drink
Smartfish
Sponsored by
Dr. Annis Fung
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aggression focused on measuring Aggression, Omega-3 supplementation, Neurocognition, Attention, Antisocial

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • children and adolescents between the age 8 and 18
  • participants who does not fit in any of the following exclusion criteria

Exclusion Criteria:

  • unwilling to participate in a randomized, double-blind, placebo controlled trial,
  • unable to give written, informed parental consent and assent from children,
  • on medication that may modify lipid metabolism in the past 3 months
  • significant use of omega-3 supplements in the past 6 months
  • seafood allergies
  • mental retardation
  • epilepsy

Sites / Locations

  • City University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Omega-3 supplemented drink

Placebo Drink

treatment-as-usual controls

Arm Description

A 200 ml. drink product with 1.1 grams of omega-3 from Smartfish (Smartfish: Forsiden in Norway).

exactly the same fruit drink contained in the same packaging, but will contain no omega-3.

No drinks are taken.

Outcomes

Primary Outcome Measures

Externalizing and internalizing behavior problems
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).

Secondary Outcome Measures

Neurocognitive functioning
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
Psychophysiological (attentional) functioning is assessed using EEG (P300 oddball task).
Emotional empathy
measured by a 10-items self-report instrument (CASES)
Grit
measured by an 8-item self-report instruments (GRIT)

Full Information

First Posted
December 29, 2014
Last Updated
July 17, 2018
Sponsor
Dr. Annis Fung
Collaborators
University of Pennsylvania, The University of Hong Kong, Brooklyn College of the City University of New York
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1. Study Identification

Unique Protocol Identification Number
NCT02334098
Brief Title
Omega-3 Supplementation and Behavior Problems
Official Title
Omega-3 Supplementation and Behavior Problems in Children and Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Annis Fung
Collaborators
University of Pennsylvania, The University of Hong Kong, Brooklyn College of the City University of New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 is more effective in children with more psychopathic-like traits.
Detailed Description
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. A secondary but important aim is to assess whether any behavioral improvement may be greater in more psychopathic children. 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 leads to greater improvement in children with psychopathic-like traits. 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 measures will be assessed at baseline (0 months), end of treatment (6 months), and 6 months post-treatment (12 months).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggression, Antisocial Behavior, Antisocial Personality
Keywords
Aggression, Omega-3 supplementation, Neurocognition, Attention, Antisocial

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
3 parallel groups: (1) omega-3 + fruit juice (2) fruit juice only (3) controls (no drink).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
all participants and research assistants are blind to condition for the two fruit juice groups
Allocation
Randomized
Enrollment
324 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omega-3 supplemented drink
Arm Type
Experimental
Arm Description
A 200 ml. drink product with 1.1 grams of omega-3 from Smartfish (Smartfish: Forsiden in Norway).
Arm Title
Placebo Drink
Arm Type
Placebo Comparator
Arm Description
exactly the same fruit drink contained in the same packaging, but will contain no omega-3.
Arm Title
treatment-as-usual controls
Arm Type
No Intervention
Arm Description
No drinks are taken.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 supplemented drink
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Smartfish
Intervention Description
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).
Primary Outcome Measure Information:
Title
Externalizing and internalizing behavior problems
Description
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).
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)
Secondary Outcome Measure Information:
Title
Neurocognitive functioning
Description
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.
Time Frame
up to 12 months
Title
Psychophysiological functioning
Description
Psychophysiological (attentional) functioning is assessed using EEG (P300 oddball task).
Time Frame
up to 12 months
Title
Emotional empathy
Description
measured by a 10-items self-report instrument (CASES)
Time Frame
up to 12 months
Title
Grit
Description
measured by an 8-item self-report instruments (GRIT)
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: children and adolescents between the age 8 and 18 participants who does not fit in any of the following exclusion criteria Exclusion Criteria: unwilling to participate in a randomized, double-blind, placebo controlled trial, unable to give written, informed parental consent and assent from children, on medication that may modify lipid metabolism in the past 3 months significant use of omega-3 supplements in the past 6 months seafood allergies mental retardation epilepsy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annis Fung, Ph.D.
Organizational Affiliation
City University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
City University of Hong Kong
City
Hong Kong
Country
China

12. IPD Sharing Statement

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Omega-3 Supplementation and Behavior Problems

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