AggressionPhase 2/3NCT02334098
Omega-3 Supplementation and Behavior Problems
A Phase 2/3 study testing Omega-3 supplemented drink and Smartfish in people with Aggression and Antisocial Behavior, run by Dr. Annis Fung at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Aggression, Antisocial Behavior, Antisocial Personality
- What is being tested?
- Omega-3 supplemented drink and Smartfish
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- 1 siteChina
- Study dates
- Feb 2015to Jul 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- children and adolescents between the age 8 and 18
- participants who does not fit in any of the following exclusion criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Omega-3 Supplementation and Behavior Problems in Children and Adolescents
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.
Read the 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).
- Conditions
- Aggression, Antisocial Behavior, Antisocial Personality
- Being tested
- Omega-3 supplemented drink, Smartfish
- Keywords
- Aggression, Omega-3 supplementation, Neurocognition, Attention, Antisocial
- Medical subject headings
- Aggression, Antisocial Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 supplemented drinkDietary 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.
SmartfishDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 supplemented drink | Experimental | A 200 ml. drink product with 1.1 grams of omega-3 from Smartfish (Smartfish: Forsiden in Norway). Receives: Dietary Supplement: Omega-3 supplemented drink |
| Placebo Drink | Placebo comparator | exactly the same fruit drink contained in the same packaging, but will contain no omega-3. Receives: Dietary Supplement: Smartfish |
| treatment-as-usual controls | No intervention | No drinks are taken. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 outcomes (4)
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.
Measured: up to 12 months
Psychophysiological functioning
Psychophysiological (attentional) functioning is assessed using EEG (P300 oddball task).
Measured: up to 12 months
Emotional empathy
measured by a 10-items self-report instrument (CASES)
Measured: up to 12 months
Grit
measured by an 8-item self-report instruments (GRIT)
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AggressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 parallel groups: (1) omega-3 + fruit juice (2) fruit juice only (3) controls (no drink).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Annis Fung
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, The University of Hong Kong, Brooklyn College of the City University of New York
- Responsible party
- Sponsor-investigator, Dr. Annis Fung, City University of Hong Kong
- Investigators
- Annis Fung, Ph.D., Principal investigator, City University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334098
- Sponsor's protocol ID
- GRF-11402514
- Status last verified
- Jul 2018
- First submitted
- 29 Dec 2014
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Supplementation and Behavior Problems in Children and Adolescents
- ClinicalTrials.gov ID
- NCT02334098
- Acronym / sponsor ID
- GRF-11402514
- Conditions
- Aggression, Antisocial Behavior, Antisocial Personality
- Keywords
- Aggression, Omega-3 supplementation, Neurocognition, Attention, Antisocial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Dr. Annis FungUniversity, hospital or other
- Collaborators
- University of Pennsylvania, The University of Hong Kong, Brooklyn College of the City University of New York
- Study start
- Feb 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 8 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 3 parallel groups: (1) omega-3 + fruit juice (2) fruit juice only (3) controls (no drink).
| Arm | Type | Receives |
|---|---|---|
| Omega-3 supplemented drink | Experimental | Dietary Supplement: Omega-3 supplemented drinkA 200 ml. drink product with 1.1 grams of omega-3 from Smartfish (Smartfish: Forsiden in Norway). |
| Placebo Drink | Placebo comparator | Dietary Supplement: Smartfishexactly the same fruit drink contained in the same packaging, but will contain no omega-3. |
| treatment-as-usual controls | No intervention | –No drinks are taken. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- children and adolescents between the age 8 and 18
- participants who does not fit in any of the following exclusion criteria
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 supplemented drinkThe 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. | Dietary supplement | Omega-3 supplemented drink |
| SmartfishTreatment duration is 6 months. They will be assessed at baseline (0 months), end of treatment (6 months) and 6 months post-treatment (12 months). | Dietary supplement | Placebo Drink |
Primary outcome
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).
4 secondary outcomes
Neurocognitive functioning
Time frame: up to 12 months
Psychophysiological functioning
Time frame: up to 12 months
Emotional empathy
Time frame: up to 12 months
Grit
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
Related trials for Aggression
Not yet recruiting
Virtual Reality to Advance Dementia Care and Quality of Life
Dementia, Agitation
Active, not recruitingPhase 2
Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas
ALK-Positive Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma Activated B-Cell Type
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
Recruiting
Virtual Reality Intervention (VR-GINSO) for Reducing Aggression in Young Offenders
Aggression
Recruiting
Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma
Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annis Fung, Ph.D. principal investigator
City University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Omega-3 supplemented drink and Smartfish in people with Aggression and Antisocial Behavior, run by Dr. Annis Fung at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.