Effect of Omega-3 Phospholipids on Perceptual-cognitive Training

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Université de Montréal
Sponsor:
Collaborator:
Neptune Technologies and Bioressources Inc.
Information provided by (Responsible Party):
Jocelyn Faubert, Université de Montréal
ClinicalTrials.gov Identifier:
NCT01856829
First received: May 9, 2013
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Cognition - Other
Dietary Supplement: Omega-3
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effect of Omega-3 Phospholipids on Attentional Abilities and Perceptual-cognitive Training

Resource links provided by NLM:


Further study details as provided by Université de Montréal:

Primary Outcome Measures:
  • Speed-thresholds performance [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 80
Study Start Date: May 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Placebo
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 Name: vegetable oil
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.
Dietary Supplement: Omega-3
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 Name: health Canada product number 80006416

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01856829

Contacts
Contact: Isabelle Legault, PhD 514-343-6111 ext 8764 isabelle.legault.3@umontreal.ca
Contact: Jocelyn Faubert, PhD 514-343-7289 jocelyn.faubert@umontreal.ca

Locations
Canada, Quebec
Visual psychophysics and perception laboratory Recruiting
Montreal, Quebec, Canada, H3T1P1
Contact: Isabelle Legault, PhD    514-343-6111 ext 8764    isabelle.legault.3@umontreal.ca   
Contact: Jocelyn Faubert, PhD    514-343-7289    jocelyn.faubert@umontreal.ca   
Principal Investigator: Jocelyn Faubert, PhD         
École d'optométrie, Université de Montréal Recruiting
Montréal, Quebec, Canada, H3T1P1
Contact: Isabelle Legault, PhD    514-343-6111 ext 8764    isabelle.legault.3@umontreal.ca   
Sponsors and Collaborators
Université de Montréal
Neptune Technologies and Bioressources Inc.
Investigators
Study Chair: Jocelyn Faubert, PhD École d'optométrie, Université de Montréal
  More Information

Publications:

Responsible Party: Jocelyn Faubert, Full Professeur, Université de Montréal
ClinicalTrials.gov Identifier: NCT01856829     History of Changes
Other Study ID Numbers: NKO-PC_01
Study First Received: May 9, 2013
Last Updated: May 28, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

ClinicalTrials.gov processed this record on September 16, 2014