Cognition - OtherNCT01856829
Effect of Omega-3 Phospholipids on Perceptual-cognitive Training
A study testing Omega-3 in people with Cognition - Other, run by Université de Montréal at 2 sites in Canada.
Trial summary
Omega 3 in the form of phospholipids are the main component of nerve cells and their oral intake is known to have a positive impact on behavior disorders such as depression or bipolar disorder. Their consumption would improve brain function while increasing the ability to concentrate. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition - Other
- What is being tested?
- Omega-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesCanada
- Study dates
- May 2013to May 2014
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 35 or from 60 to 75 years;
- binocular visual acuity greater or equal to 6/6 (Snellen), with or without correction;
- Stereoacuity greater than 40 second of arc measured by the Frisby Stereo acuity test; Visual Field without anomalies or constriction;
- Scores for the mini-mental-state-examination(elderly person only) greater than 24/30
- Good general health
Who cannot join
- If you are taking medication acting on vigilance and attention;
- If you suffer from any eye diseases (glaucoma, age-related macular degeneration, diabetic retinopathy);
- If you suffer from postural balance disorders.
- If you suffer from chronic or severe diseases, including neurological disorders (eg epilepsy).
- If you are an elite athlete.
- If you eat fish or seafood more than 2 times per week;
Show all 15Show fewer
- If you play at video games 3 hours or more per day / 5 days a week or more.
- If you suffer from allergy to fish or seafood
- If you consumed or have consumed in the previous 3 months, food supplements based on omega-3 (eg oil of fish or Krill Oil)
- If you have a blood coagulation disorder, or are receiving anticoagulant therapy.
- If you have participated in a clinical study in a period shorter than four weeks
- If you do not understand the constraints of the study.
- If you refuse to give your written consent.
- If you are pregnant or breastfeeding.
- If you got a speed threshold 40% higher than the group average, in the first session tracking targets.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Visual psychophysics and perception laboratory
Montreal, Quebec, H3T1P1
École d'optométrie, Université de Montréal
Montreal, Quebec, H3T1P1
About this study
Official title: Effect of Omega-3 Phospholipids on Attentional Abilities and Perceptual-cognitive Training
Omega 3 in the form of phospholipids are the main component of nerve cells and their oral intake is known to have a positive impact on behavior disorders such as depression or bipolar disorder. Their consumption would improve brain function while increasing the ability to concentrate. The study aims to determine the effect of an increase in Omega 3 in the form of phospholipids on the processing of visual information in the brain and in particular the attention and perceptual-cognitive learning in a three dimensions environment. Eighty subjects (40 young (18-35 years) and 40 older (60-75 years)) divided into four groups, two Omega-3 (20 young and 20 older) and two other placebo (20 young and 20 elderly ), will in this study, performing a complex perceptual-cognitive task such as the pursuit of moving objects in a 3D space. This stimulus was chosen because it is very similar to the situations of daily life, but also because it involves a mechanism of perceptual-cognitive level. The main objective is to demonstrate the positive effect of Omega-3 phospholipids on the perceptual-cognitive training.
Read the detailed description
Improve visual skills through training and perceptual-cognitive learning could be a method aimed to repair partial neurophysiological deficits or produce new brain networks. Studies suggest that the mechanisms of attention and cortical plasticity have a role to play in information retrieval. In addition, he has been shown that Omega 3 in the form of phospholipids are the main component of nerve cells and taken orally makes a positive impact on behavior disorders such as depression or bipolar disorder. Their consumption would also help improve brain function while increasing the ability to concentrate.
The perceptual-cognitive ability is a very high level treatment of complex visual information. However, this ability only has our brain seems to be driven by the fact that the brain has great plasticity. This means that there is a neuronal reorganization in learning new capacity. 3D-MOT, or 3-Dimensional Multiple Object Tracking is a technique that allows the study of the visual system for tracking moving targets in 3D. It is a task of multifocal attentional pursuit which assesses the ability to keep the position of different moving targets from other similar objects. Performance is measured based on the number of objects that have been successfully followed. Previous studies have also shown that most young patients can typically take four objects simultaneously. In addition, this tracking capability, when speed is used as the dependent variable seems drivable. Therefore, Faubert and Sidebottom have shown that young people could significantly increase their speed thresholds. Legault and Faubert (2012) have demonstrated that training with the method of 3D-MOT generates significant improvements in visual-cognitive abilities as the perception of movement of the human body, a crucial index to avoid collisions when we navigate in a dense crowd for example.
The purpose of this project is to evaluate the impact of taking Omega-3 phospholipid form on perceptual-cognitive abilities, on the learning rate (curve) of young and older adults. The sample is composed of 40 young people (20 to 35) and 40 older adults (60-75) divided into two groups. The stimulus will be a task of multiple objects or 3D-MOT that consist to simultaneously track multiple moving objects among distractors, all will be presented on a 3D television screen . The performance of the observer (speed thresholds) will be evaluated based on three elements followed without error.
- Conditions
- Cognition - Other
- Being tested
- Omega-3, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Dietary supplement
Also called health Canada product number 80006416
The capsule will be take daily for 4 weeks before and for the duration of the tests of the perceptual-cognitive training protocol. The testing period will held at intervals of 3 to 7 days for 5 sessions (maximum of 5 weeks testing). Taking products will be made more specifically 30 minutes before the start of the sessions.
PlaceboOther
Also called vegetable oil
The capsule will be take daily for 4 weeks before and for the duration of the tests of the perceptual-cognitive training protocol. The testing period will held at intervals of 3 to 7 days for 5 sessions (maximum of 5 weeks testing). Taking products will be made more specifically 30 minutes before the start of the sessions.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Control participants will take placebo capsules daily for 4 weeks before and for the duration of the test. At week 4, participants will undergo a training protocol consists of a series of five sessions consecutively performed at intervals of 3 to 7 days. Taking products will be made more specifically 30 minutes before the start of the sessions. Receives: Other: Placebo |
| Omega-3 | Experimental | Omega-3 participants will take capsules daily for 4 weeks before and for the duration of the test. At week 4, participants will undergo a training protocol consists of a series of five sessions consecutively performed at intervals of 3 to 7 days. Taking products will be made more specifically 30 minutes before the start of the sessions. Receives: Dietary Supplement: Omega-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed-thresholds performance
We will measure speed thresholds performance on a perceptual-cognitive task while participants will take Omega-3 or a placebo. Products comply with applicable regulations by Health Canada (80033441). The participants will take capsule daily for 4 weeks before and for the duration of the perceptual-cognitive training protocol. Participant will not be inform on the nature of their capsule (Omega-3 or placebo). All participants will undergo a training protocol that consists of a series of five sessions performed at intervals of 3 to 7 days. The product will be taken 30 minutes before the start of the sessions. During the sessions, participants will perform a 3D-multiple object tracking task. The stimulus consists to simultaneously track multiple moving objects among distractors and we measured the maximum speed at which the objects could travel, for younger and older observers to complete the task with no errors.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cognition - OtherStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Neptune Technologies and Bioressources Inc.
- Responsible party
- Principal investigator, Jocelyn Faubert, Université de Montréal
- Investigators
- Jocelyn Faubert, PhD, Study chair, École d'optométrie, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856829
- Sponsor's protocol ID
- NKO-PC_01
- Status last verified
- May 2018
- First submitted
- 9 May 2013
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alvarez GA, Franconeri SL. How many objects can you track? Evidence for a resource-limited attentive tracking mechanism. J Vis. 2007 Oct 30;7(13):14.1-10. doi: 10.1167/7.13.14.
PubMed 17997642Bloch MH, Qawasmi A. Omega-3 fatty acid supplementation for the treatment of children with attention-deficit/hyperactivity disorder symptomatology: systematic review and meta-analysis. J Am Acad Child Adolesc Psychiatry. 2011 Oct;50(10):991-1000. doi: 10.1016/j.jaac.2011.06.008. Epub 2011 Aug 12.
PubMed 21961774Draganski B, May A. Training-induced structural changes in the adult human brain. Behav Brain Res. 2008 Sep 1;192(1):137-42. doi: 10.1016/j.bbr.2008.02.015. Epub 2008 Feb 17.
PubMed 18378330Legault I, Faubert J. Perceptual-cognitive training improves biological motion perception: evidence for transferability of training in healthy aging. Neuroreport. 2012 May 30;23(8):469-73. doi: 10.1097/WNR.0b013e328353e48a.
PubMed 22495038Pylyshyn Z. The role of location indexes in spatial perception: a sketch of the FINST spatial-index model. Cognition. 1989 Jun;32(1):65-97. doi: 10.1016/0010-0277(89)90014-0.
PubMed 2752706Sabel BA, Henrich-Noack P, Fedorov A, Gall C. Vision restoration after brain and retina damage: the "residual vision activation theory". Prog Brain Res. 2011;192:199-262. doi: 10.1016/B978-0-444-53355-5.00013-0.
PubMed 21763527Sarris J, Mischoulon D, Schweitzer I. Omega-3 for bipolar disorder: meta-analyses of use in mania and bipolar depression. J Clin Psychiatry. 2012 Jan;73(1):81-6. doi: 10.4088/JCP.10r06710. Epub 2011 Aug 9.
PubMed 21903025Sublette ME, Ellis SP, Geant AL, Mann JJ. Meta-analysis of the effects of eicosapentaenoic acid (EPA) in clinical trials in depression. J Clin Psychiatry. 2011 Dec;72(12):1577-84. doi: 10.4088/JCP.10m06634. Epub 2011 Sep 6.
PubMed 21939614Mahncke HW, Connor BB, Appelman J, Ahsanuddin ON, Hardy JL, Wood RA, Joyce NM, Boniske T, Atkins SM, Merzenich MM. Memory enhancement in healthy older adults using a brain plasticity-based training program: a randomized, controlled study. Proc Natl Acad Sci U S A. 2006 Aug 15;103(33):12523-8. doi: 10.1073/pnas.0605194103. Epub 2006 Aug 3.
PubMed 16888038Faubert J, Sidebottom L. Perceptual-cognitive training of athletes. Journal of clinical sports psychology (6):85-102, 2012.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Omega-3 Phospholipids on Attentional Abilities and Perceptual-cognitive Training
- ClinicalTrials.gov ID
- NCT01856829
- Acronym / sponsor ID
- NKO-PC_01
- Conditions
- Cognition - Other
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- Neptune Technologies and Bioressources Inc.
- Study start
- May 2013 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 May 2013 (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.
Omega 3 in the form of phospholipids are the main component of nerve cells and their oral intake is known to have a positive impact on behavior disorders such as depression or bipolar disorder. Their consumption would improve brain function while increasing the ability to concentrate. The study aims to determine the effect of an increase in Omega 3 in the form of phospholipids on the processing of visual information in the brain and in particular the attention and perceptual-cognitive learning in a three dimensions environment. Eighty subjects (40 young (18-35 years) and 40 older (60-75 years)) divided into four groups, two Omega-3 (20 young and 20 older) and two other placebo (20 young and 20 elderly ), will in this study, performing a complex perceptual-cognitive task such as the pursuit of moving objects in a 3D space. This stimulus was chosen because it is very similar to the situations of daily life, but also because it involves a mechanism of perceptual-cognitive level. The main objective is to demonstrate the positive effect of Omega-3 phospholipids on the perceptual-cognitive training.
Detailed description
Improve visual skills through training and perceptual-cognitive learning could be a method aimed to repair partial neurophysiological deficits or produce new brain networks. Studies suggest that the mechanisms of attention and cortical plasticity have a role to play in information retrieval. In addition, he has been shown that Omega 3 in the form of phospholipids are the main component of nerve cells and taken orally makes a positive impact on behavior disorders such as depression or bipolar disorder. Their consumption would also help improve brain function while increasing the ability to concentrate.
The perceptual-cognitive ability is a very high level treatment of complex visual information. However, this ability only has our brain seems to be driven by the fact that the brain has great plasticity. This means that there is a neuronal reorganization in learning new capacity. 3D-MOT, or 3-Dimensional Multiple Object Tracking is a technique that allows the study of the visual system for tracking moving targets in 3D. It is a task of multifocal attentional pursuit which assesses the ability to keep the position of different moving targets from other similar objects. Performance is measured based on the number of objects that have been successfully followed. Previous studies have also shown that most young patients can typically take four objects simultaneously. In addition, this tracking capability, when speed is used as the dependent variable seems drivable. Therefore, Faubert and Sidebottom have shown that young people could significantly increase their speed thresholds. Legault and Faubert (2012) have demonstrated that training with the method of 3D-MOT generates significant improvements in visual-cognitive abilities as the perception of movement of the human body, a crucial index to avoid collisions when we navigate in a dense crowd for example.
The purpose of this project is to evaluate the impact of taking Omega-3 phospholipid form on perceptual-cognitive abilities, on the learning rate (curve) of young and older adults. The sample is composed of 40 young people (20 to 35) and 40 older adults (60-75) divided into two groups. The stimulus will be a task of multiple objects or 3D-MOT that consist to simultaneously track multiple moving objects among distractors, all will be presented on a 3D television screen . The performance of the observer (speed thresholds) will be evaluated based on three elements followed without error.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: PlaceboControl participants will take placebo capsules daily for 4 weeks before and for the duration of the test. At week 4, participants will undergo a training protocol consists of a series of five sessions consecutively performed at intervals of 3 to 7 days. Taking products will be made more specifically 30 minutes before the start of the sessions. |
| Omega-3 | Experimental | Dietary Supplement: Omega-3Omega-3 participants will take capsules daily for 4 weeks before and for the duration of the test. At week 4, participants will undergo a training protocol consists of a series of five sessions consecutively performed at intervals of 3 to 7 days. Taking products will be made more specifically 30 minutes before the start of the sessions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 35 or from 60 to 75 years;
- binocular visual acuity greater or equal to 6/6 (Snellen), with or without correction;
- Stereoacuity greater than 40 second of arc measured by the Frisby Stereo acuity test; Visual Field without anomalies or constriction;
- Scores for the mini-mental-state-examination(elderly person only) greater than 24/30
- Good general health
Key exclusion criteria (15 listed)
- If you are taking medication acting on vigilance and attention;
- If you suffer from any eye diseases (glaucoma, age-related macular degeneration, diabetic retinopathy);
- If you suffer from postural balance disorders.
- If you suffer from chronic or severe diseases, including neurological disorders (eg epilepsy).
- If you are an elite athlete.
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-3Also: health Canada product number 80006416The capsule will be take daily for 4 weeks before and for the duration of the tests of the perceptual-cognitive training protocol. The testing period will held at intervals of 3 to 7 days for 5 sessions (maximum of 5 weeks testing). Taking products will be made more specifically 30 minutes before the start of the sessions. | Dietary supplement | Omega-3 |
| PlaceboAlso: vegetable oilThe capsule will be take daily for 4 weeks before and for the duration of the tests of the perceptual-cognitive training protocol. The testing period will held at intervals of 3 to 7 days for 5 sessions (maximum of 5 weeks testing). Taking products will be made more specifically 30 minutes before the start of the sessions. | Other | Control |
Primary outcome
Speed-thresholds performance
Time frame: 6 weeks
We will measure speed thresholds performance on a perceptual-cognitive task while participants will take Omega-3 or a placebo. Products comply with applicable regulations by Health Canada (80033441). The participants will take capsule daily for 4 weeks before and for the duration of the perceptual-cognitive training protocol. Participant will not be inform on the nature of their capsule (Omega-3 or placebo). All participants will undergo a training protocol that consists of a series of five sessions performed at intervals of 3 to 7 days. The product will be taken 30 minutes before the start of the sessions. During the sessions, participants will perform a 3D-multiple object tracking task. The stimulus consists to simultaneously track multiple moving objects among distractors and we measured the maximum speed at which the objects could travel, for younger and older observers to complete the task with no errors.
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 May 2018.
- Background: PubMed 17997642Alvarez GA, Franconeri SL. How many objects can you track? Evidence for a resource-limited attentive tracking mechanism. J Vis. 2007 Oct 30;7(13):14.1-10. doi: 10.1167/7.13.14.
- Background: PubMed 21961774Bloch MH, Qawasmi A. Omega-3 fatty acid supplementation for the treatment of children with attention-deficit/hyperactivity disorder symptomatology: systematic review and meta-analysis. J Am Acad Child Adolesc Psychiatry. 2011 Oct;50(10):991-1000. doi: 10.1016/j.jaac.2011.06.008. Epub 2011 Aug 12.
- Background: PubMed 18378330Draganski B, May A. Training-induced structural changes in the adult human brain. Behav Brain Res. 2008 Sep 1;192(1):137-42. doi: 10.1016/j.bbr.2008.02.015. Epub 2008 Feb 17.
- Background: PubMed 22495038Legault I, Faubert J. Perceptual-cognitive training improves biological motion perception: evidence for transferability of training in healthy aging. Neuroreport. 2012 May 30;23(8):469-73. doi: 10.1097/WNR.0b013e328353e48a.
- Background: PubMed 2752706Pylyshyn Z. The role of location indexes in spatial perception: a sketch of the FINST spatial-index model. Cognition. 1989 Jun;32(1):65-97. doi: 10.1016/0010-0277(89)90014-0.
- Background: PubMed 21763527Sabel BA, Henrich-Noack P, Fedorov A, Gall C. Vision restoration after brain and retina damage: the "residual vision activation theory". Prog Brain Res. 2011;192:199-262. doi: 10.1016/B978-0-444-53355-5.00013-0.
- Background: PubMed 21903025Sarris J, Mischoulon D, Schweitzer I. Omega-3 for bipolar disorder: meta-analyses of use in mania and bipolar depression. J Clin Psychiatry. 2012 Jan;73(1):81-6. doi: 10.4088/JCP.10r06710. Epub 2011 Aug 9.
- Background: PubMed 21939614Sublette ME, Ellis SP, Geant AL, Mann JJ. Meta-analysis of the effects of eicosapentaenoic acid (EPA) in clinical trials in depression. J Clin Psychiatry. 2011 Dec;72(12):1577-84. doi: 10.4088/JCP.10m06634. Epub 2011 Sep 6.
- Background: PubMed 16888038Mahncke HW, Connor BB, Appelman J, Ahsanuddin ON, Hardy JL, Wood RA, Joyce NM, Boniske T, Atkins SM, Merzenich MM. Memory enhancement in healthy older adults using a brain plasticity-based training program: a randomized, controlled study. Proc Natl Acad Sci U S A. 2006 Aug 15;103(33):12523-8. doi: 10.1073/pnas.0605194103. Epub 2006 Aug 3.
- BackgroundFaubert J, Sidebottom L. Perceptual-cognitive training of athletes. Journal of clinical sports psychology (6):85-102, 2012.
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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.
Jocelyn Faubert, PhD study chair
École d'optométrie, Université de Montréal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 in people with Cognition - Other, run by Université de Montréal at 2 sites in Canada.
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 5 inclusion and 15 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 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Speed-thresholds performance (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01856829, which also lists 10 linked publications.
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 May 2018.