Omega-3 Supplementation and Behavior Problems

NCT ID: NCT02334098

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 324 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-07-31

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.

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).

Conditions

Aggression; Antisocial Behavior; Antisocial Personality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Omega-3 supplemented drink

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

Group Type: EXPERIMENTAL

Omega-3 supplemented drink

Intervention Type: DIETARY_SUPPLEMENT

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 Drink

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

Group Type: PLACEBO_COMPARATOR

Smartfish

Intervention Type: DIETARY_SUPPLEMENT

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).

treatment-as-usual controls

No drinks are taken.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• children and adolescents between the age 8 and 18

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: collaborator

Brooklyn College of the City University of New York

OTHER

Sponsor Role: collaborator

Dr. Annis Fung

OTHER

Sponsor Role: lead

Responsible Party

Dr. Annis Fung

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Annis Fung, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

City University of Hong Kong

Locations

City University of Hong Kong

Hong Kong, , China

Countries

China

Other Identifiers

GRF-11402514

Identifier Type: -

Identifier Source: org_study_id