NCT01856829

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 17, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

7 months

First QC Date

May 9, 2013

Last Update Submit

May 8, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks

Study Arms (2)

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.

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.

Dietary Supplement: Omega-3

Interventions

Omega-3DIETARY_SUPPLEMENT

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.

Also known as: health Canada product number 80006416
Omega-3
PlaceboOTHER

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.

Also known as: vegetable oil
Control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Visual psychophysics and perception laboratory

Montreal, Quebec, H3T1P1, Canada

Location

École d'optométrie, Université de Montréal

Montreal, Quebec, H3T1P1, Canada

Location

Related Publications (10)

  • 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.

    PMID: 17997642BACKGROUND
  • 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.

    PMID: 21961774BACKGROUND
  • 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.

    PMID: 18378330BACKGROUND
  • 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.

    PMID: 22495038BACKGROUND
  • 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.

    PMID: 2752706BACKGROUND
  • 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.

    PMID: 21763527BACKGROUND
  • 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.

    PMID: 21903025BACKGROUND
  • 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.

    PMID: 21939614BACKGROUND
  • 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.

    PMID: 16888038BACKGROUND
  • Faubert J, Sidebottom L. Perceptual-cognitive training of athletes. Journal of clinical sports psychology (6):85-102, 2012.

    BACKGROUND

MeSH Terms

Interventions

Docosahexaenoic AcidsPlant Oils

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Jocelyn Faubert, PhD

    École d'optométrie, Université de Montréal

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professeur

Study Record Dates

First Submitted

May 9, 2013

First Posted

May 17, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2013

Study Completion

May 1, 2014

Last Updated

May 9, 2018

Record last verified: 2018-05

Locations