ClinicalTrials.gov
ClinicalTrials.gov Menu

Omega-3 Supplementation and Behavior Problems

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02334098
Recruitment Status : Completed
First Posted : January 8, 2015
Last Update Posted : July 18, 2018
Sponsor:
Collaborators:
University of Pennsylvania
The University of Hong Kong
Brooklyn College of the City University of New York
Information provided by (Responsible Party):
Dr. Annis Fung, City University of Hong Kong

Brief Summary:

The objectives of this project are as follows:

  1. 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
  2. To assess whether omega-3 supplementation is more effective in children with more psychopathic-like traits.

Condition or disease Intervention/treatment Phase
Aggression Antisocial Behavior Antisocial Personality Dietary Supplement: Omega-3 supplemented drink Dietary Supplement: Smartfish Phase 2 Phase 3

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:

  1. To assess the effectiveness of omega-3 dietary supplementation in reducing externalizing behaviors in adolescents.
  2. 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).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3 parallel groups: (1) omega-3 + fruit juice (2) fruit juice only (3) controls (no drink).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: all participants and research assistants are blind to condition for the two fruit juice groups
Primary Purpose: Prevention
Official Title: Omega-3 Supplementation and Behavior Problems in Children and Adolescents
Actual Study Start Date : February 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. 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.

  2. Psychophysiological functioning [ Time Frame: up to 12 months ]
    Psychophysiological (attentional) functioning is assessed using EEG (P300 oddball task).

  3. Emotional empathy [ Time Frame: up to 12 months ]
    measured by a 10-items self-report instrument (CASES)

  4. Grit [ Time Frame: up to 12 months ]
    measured by an 8-item self-report instruments (GRIT)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334098


Locations
China
City University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
Dr. Annis Fung
University of Pennsylvania
The University of Hong Kong
Brooklyn College of the City University of New York
Investigators
Principal Investigator: Annis Fung, Ph.D. City University of Hong Kong

Responsible Party: Dr. Annis Fung, Associate Professor, City University of Hong Kong
ClinicalTrials.gov Identifier: NCT02334098     History of Changes
Other Study ID Numbers: GRF-11402514
First Posted: January 8, 2015    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Annis Fung, City University of Hong Kong:
Aggression
Omega-3 supplementation
Neurocognition
Attention
Antisocial

Additional relevant MeSH terms:
Aggression
Problem Behavior
Antisocial Personality Disorder
Behavioral Symptoms
Personality Disorders
Mental Disorders