- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01856829
Effect of Omega-3 Phospholipids on Perceptual-cognitive Training
Effect of Omega-3 Phospholipids on Attentional Abilities and Perceptual-cognitive Training
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Quebec
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Montreal, Quebec, Canada, H3T1P1
- Visual psychophysics and perception laboratory
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Montréal, Quebec, Canada, H3T1P1
- École d'optométrie, Université de Montréal
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
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.
|
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.
Other Names:
|
Experimental: Omega-3
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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6 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Jocelyn Faubert, PhD, École d'optométrie, Université de Montréal
Publications and helpful links
General Publications
- Mahncke 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.
- Sublette 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.
- Sabel 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.
- 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.
- Bloch 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.
- Draganski 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.
- Legault 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.
- Pylyshyn 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.
- Sarris 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.
- Faubert J, Sidebottom L. Perceptual-cognitive training of athletes. Journal of clinical sports psychology (6):85-102, 2012.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NKO-PC_01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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