BehaviourNCT02346773
Effects of Omega-3 Fatty Acids Supplementation on Brain and Behaviour in Healthy Children.
A study testing ω-3 LC-PUFA in people with Behaviour, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Currently, there is considerable interest in the possibility that dietary supplementation with fatty acids, mostly omega-3 fatty acids, will have potential benefits for brain development. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Behaviour
- What is being tested?
- ω-3 LC-PUFA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2008to Dec 2009
- Phase
- Interventional
- 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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child in target age (9-12 yrs)
- Child native language English
- Child is available for providing a blood sample
- Child is available for MRI scan
Who cannot join
- 1) eating fatty fish/shellfish more than once a week;
- 2) using ω-3 and/or ω-6 LC-PUFA supplements more than once a week;
- 3) consuming products fortified with ω-3 LC-PUFA (EPA and/or DHA >100 mg/day) in the three months prior to study participation;
- 4) positive history of alcohol abuse during pregnancy;
- 5) positive history of malignancy and heart disease requiring heart surgery;
- 6) Premature birth (< 35 weeks) and/or detached placenta
Show all 16Show fewer
- 7) Hyperbilirubinemia requiring transfusion
- 8) severe mental illness (e.g. autism, schizophrenia) or mental retardation;
- 9) MRI contraindications
- 10) Type 1 diabetes
- 11) Epilepsy
- 12) Brain tumour
- 13) Head trauma with loss of consciousness >30 minutes
- 14) Muscular dystrophy, myotonic dystrophy
- 15) Nutritional and metabolic diseases (e.g. failure to thrive, phenylketonuria)
- 16) Hearing deficit (requiring hearing aid)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brain and Body Centre, School of Psychology, University of Nottingham
Nottingham, NG7 2RD
About this study
Currently, there is considerable interest in the possibility that dietary supplementation with fatty acids, mostly omega-3 fatty acids, will have potential benefits for brain development. Epidemiological and clinical studies support the idea that relative disappearance of omega-3 diet from the diet in developed countries has been linked with increases in both physical and mental disorders. Omega-3 deficiency may lead to cognitive impairment, motor dysfunction and visual acuity problems. It is further known that families with lower socioeconomic status may have poorer diet and, consequently, may not realize their full potential regarding their cognitive abilities. The aim of this project is to evaluate effectiveness of a diet intervention rich in omega-3 acid in healthy children 9-to-12 years old from less well-off families.
Read the detailed description
Background It has been established that a safe environment, adequate stimulation, and parental care play a major role in brain development. An adequate diet is also critically important for brain development in growing children. It has been suggested that omega-3 fatty acids are essential to human health as well as cognitive development. Omega-3 acid is important during prenatal human brain development, especially for synaptogenesis. Levels of omega-3 amino acids in during prenatal and early postnatal (breastfeeding) periods depend on their levels in maternal circulation. Later on, omega-3 must be present in the child's diet. It seems that omega-3 deficiency may associated with impaired visual acuity, cognition, cerebellar dysfunction and other neurological disorders (Haag, 2003; Review). Thus, omega-3 supplementation may be beneficial in children with poor diet, often associated with a lower socioeconomic level (Northstone et al. 2008).
Aims and Design We assessed effects of Omega-3 supplementation on brain and behaviour of 40 healthy children 9-to-12 years old. Since diet supplementation may be beneficial in particular to children with poor diet, we recruited children in less well-off neighbourhoods, as determined by the Index of Multiple Deprivation 2007. Our aim was to examine differences on cognitive performance pre and post diet supplementation.
The brain structure was assessed using magnetic resonance imaging (MRI). Cognitive abilities as well as behavioural problems were assessed using a comprehensive battery of tests and questionnaires. To evaluate the effectiveness of the supplementation, we collected a blood sample to investigate the fatty acids level in the blood. The above assessments were carried out twice: before and after a 3-month dietary intervention.
The dietary intervention included a daily use, for a period of three months, of margarine enriched (Experimental group) or not (placebo group) with Omega-3 fatty acids. We hypothesized that this intervention will improve some cognitive deficits (such as attention, processing speed) and behavioural symptoms (e.g. depression, aggressiveness, impulsivity) together with an impact on brain structure (e.g. white-matter properties related to myelination).
Experimental Protocol Each participant participated in two phases: a clinical assessment phase (to assure exclusion and inclusion criteria) and an experimental phase. The experimental phase consisted of the baseline (pre-intervention) assessment, the diet intervention (3 months) and the post-intervention assessment.
At baseline, both groups (enriched diet and placebo) underwent a cognitive assessment and MRI. Parents were asked to complete a questionnaire about the child's behaviour and some demographical data such as number of children, education etc. Children were also asked to provide a blood sample, which was taken by a fully trained and licensed team member.
After the baseline assessment, experimental group (n=20) and control group (n=20) followed a diet supplementation with omega-3 fatty acids or placebo diet respectively. The intervention lasted for three months and then the tests were re-administered for both groups (cases and controls). Parents were also asked to complete a brief questionnaire to measure children's behaviour.
- Conditions
- Behaviour
- Being tested
- ω-3 LC-PUFA, Placebo
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ω-3 LC-PUFADietary supplement
The intervention product was a full fat (80%) margarine.Participants were provided with one-month supply of the intervention product (including reserve products) at the onset of the intervention and received a new supply monthly. The intervention products were provided in neutral serving-sized cups, each containing 10 grams of margarine.The child's parents were instructed to have their child consume one complete portion pack (10 g) of margarine per day. The margarine had to be consumed as spread on sandwiches, crackers or bread rolls.The intervention product could be consumed on various periods over the day or all at one occasion. Every day a new portion pack had to be used, even if there was margarine left in the package of the previous day.
PlaceboOther
The placebo product was a similar margarine with the same sensory properties, but with monounsaturated fatty acids (MUFA; refined plant oils) replacing EPA and DHA; total saturated fatty acids (SAFA) and ω-6 long chain polyunsaturated fatty acids (LC-PUFA) content were similar between the active and placebo products.
| Study group | Role | What they receive |
|---|---|---|
| ω-3 LC-PUFA group | Active comparator | The intervention product was a full fat (80%) margarine. The active intervention product contained 590 mg docosahexaenoic acid (DHA) and 650 mg eicosapentaenoic acid (EPA) per 10-g daily serving. Receives: Dietary Supplement: ω-3 LC-PUFA |
| Placebo group | Placebo comparator | The placebo product was a similar margarine with the same sensory properties, but with monounsaturated fatty acids (MUFA; refined plant oils) replacing EPA and DHA; total saturated fatty acids (SAFA) and ω-6 long chain polyunsaturated fatty acids (LC-PUFA) content were similar between the active and placebo products. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multi-modal Magnetic Resonance Imaging (MRI): Investigating the effects of three months of EPA&DHA supplementation on brain structure of healthy children 9-to-12 years old.
Measured: Change from baseline MRI measures (DTI, MTR, MRS) at 3 months
Secondary outcomes (1)
Cognitive assessment as measured by neuropsychological testing
Neuropsychological testing: Intelligence Quotient (WISC-IV), Processing Speed (Trail Making Test), Selective \& Sustained Attention (Ruff 2\&7 Test), Working Memory (Self Ordered Pointing Test), Wisconsin Card Sorting Test
Measured: Change from baseline cognitive assessment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startNov 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BehaviourStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever R&D
- Responsible party
- Sponsor
- Investigators
- Tomáš Paus, M.D., Ph.D., Principal investigator, Rotman Research Institute, University of Toronto, Toronto, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346773
- Sponsor's protocol ID
- UNottingham
- Status last verified
- Dec 2015
- First submitted
- 22 Dec 2014
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Omega-3 Fatty Acids Supplementation on Brain and Behaviour in Healthy Children.
- ClinicalTrials.gov ID
- NCT02346773
- Acronym / sponsor ID
- UNottingham
- Conditions
- Behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Unilever R&D
- Study start
- Nov 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 27 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.
Currently, there is considerable interest in the possibility that dietary supplementation with fatty acids, mostly omega-3 fatty acids, will have potential benefits for brain development. Epidemiological and clinical studies support the idea that relative disappearance of omega-3 diet from the diet in developed countries has been linked with increases in both physical and mental disorders. Omega-3 deficiency may lead to cognitive impairment, motor dysfunction and visual acuity problems. It is further known that families with lower socioeconomic status may have poorer diet and, consequently, may not realize their full potential regarding their cognitive abilities. The aim of this project is to evaluate effectiveness of a diet intervention rich in omega-3 acid in healthy children 9-to-12 years old from less well-off families.
Detailed description
Background It has been established that a safe environment, adequate stimulation, and parental care play a major role in brain development. An adequate diet is also critically important for brain development in growing children. It has been suggested that omega-3 fatty acids are essential to human health as well as cognitive development. Omega-3 acid is important during prenatal human brain development, especially for synaptogenesis. Levels of omega-3 amino acids in during prenatal and early postnatal (breastfeeding) periods depend on their levels in maternal circulation. Later on, omega-3 must be present in the child's diet. It seems that omega-3 deficiency may associated with impaired visual acuity, cognition, cerebellar dysfunction and other neurological disorders (Haag, 2003; Review). Thus, omega-3 supplementation may be beneficial in children with poor diet, often associated with a lower socioeconomic level (Northstone et al. 2008).
Aims and Design We assessed effects of Omega-3 supplementation on brain and behaviour of 40 healthy children 9-to-12 years old. Since diet supplementation may be beneficial in particular to children with poor diet, we recruited children in less well-off neighbourhoods, as determined by the Index of Multiple Deprivation 2007. Our aim was to examine differences on cognitive performance pre and post diet supplementation.
The brain structure was assessed using magnetic resonance imaging (MRI). Cognitive abilities as well as behavioural problems were assessed using a comprehensive battery of tests and questionnaires. To evaluate the effectiveness of the supplementation, we collected a blood sample to investigate the fatty acids level in the blood. The above assessments were carried out twice: before and after a 3-month dietary intervention.
The dietary intervention included a daily use, for a period of three months, of margarine enriched (Experimental group) or not (placebo group) with Omega-3 fatty acids. We hypothesized that this intervention will improve some cognitive deficits (such as attention, processing speed) and behavioural symptoms (e.g. depression, aggressiveness, impulsivity) together with an impact on brain structure (e.g. white-matter properties related to myelination).
Experimental Protocol Each participant participated in two phases: a clinical assessment phase (to assure exclusion and inclusion criteria) and an experimental phase. The experimental phase consisted of the baseline (pre-intervention) assessment, the diet intervention (3 months) and the post-intervention assessment.
At baseline, both groups (enriched diet and placebo) underwent a cognitive assessment and MRI. Parents were asked to complete a questionnaire about the child's behaviour and some demographical data such as number of children, education etc. Children were also asked to provide a blood sample, which was taken by a fully trained and licensed team member.
After the baseline assessment, experimental group (n=20) and control group (n=20) followed a diet supplementation with omega-3 fatty acids or placebo diet respectively. The intervention lasted for three months and then the tests were re-administered for both groups (cases and controls). Parents were also asked to complete a brief questionnaire to measure children's behaviour.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ω-3 LC-PUFA group | Active comparator | Dietary Supplement: ω-3 LC-PUFAThe intervention product was a full fat (80%) margarine. The active intervention product contained 590 mg docosahexaenoic acid (DHA) and 650 mg eicosapentaenoic acid (EPA) per 10-g daily serving. |
| Placebo group | Placebo comparator | Other: PlaceboThe placebo product was a similar margarine with the same sensory properties, but with monounsaturated fatty acids (MUFA; refined plant oils) replacing EPA and DHA; total saturated fatty acids (SAFA) and ω-6 long chain polyunsaturated fatty acids (LC-PUFA) content were similar between the active and placebo products. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child in target age (9-12 yrs)
- Child native language English
- Child is available for providing a blood sample
- Child is available for MRI scan
Key exclusion criteria (16 listed)
- 1) eating fatty fish/shellfish more than once a week;
- 2) using ω-3 and/or ω-6 LC-PUFA supplements more than once a week;
- 3) consuming products fortified with ω-3 LC-PUFA (EPA and/or DHA >100 mg/day) in the three months prior to study participation;
- 4) positive history of alcohol abuse during pregnancy;
- 5) positive history of malignancy and heart disease requiring heart surgery;
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 |
|---|---|---|
| ω-3 LC-PUFAThe intervention product was a full fat (80%) margarine.Participants were provided with one-month supply of the intervention product (including reserve products) at the onset of the intervention and received a new supply monthly. The intervention products were provided in neutral serving-sized cups, each containing 10 grams of margarine.The child's parents were instructed to have their child consume one complete portion pack (10 g) of margarine per day. The margarine had to be consumed as spread on sandwiches, crackers or bread rolls.The intervention product could be consumed on various periods over the day or all at one occasion. Every day a new portion pack had to be used, even if there was margarine left in the package of the previous day. | Dietary supplement | ω-3 LC-PUFA group |
| PlaceboThe placebo product was a similar margarine with the same sensory properties, but with monounsaturated fatty acids (MUFA; refined plant oils) replacing EPA and DHA; total saturated fatty acids (SAFA) and ω-6 long chain polyunsaturated fatty acids (LC-PUFA) content were similar between the active and placebo products. | Other | Placebo group |
Primary outcome
Multi-modal Magnetic Resonance Imaging (MRI): Investigating the effects of three months of EPA&DHA supplementation on brain structure of healthy children 9-to-12 years old.
Time frame: Change from baseline MRI measures (DTI, MTR, MRS) at 3 months
1 secondary outcome
Cognitive assessment as measured by neuropsychological testing
Time frame: Change from baseline cognitive assessment at 3 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 9 Dec 2015.
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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.
Tomáš Paus, M.D., Ph.D. principal investigator
Rotman Research Institute, University of Toronto, Toronto, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ω-3 LC-PUFA in people with Behaviour, run by University of Nottingham at 1 site in United Kingdom.
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 4 inclusion and 16 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 9 Dec 2015. 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 United Kingdom. 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.
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?
Multi-modal Magnetic Resonance Imaging (MRI): Investigating the effects of three months of EPA&DHA supplementation on brain structure of healthy children 9-to-12 years old. (time frame: Change from baseline MRI measures (DTI, MTR, MRS) at 3 months). 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 9 Dec 2015.