- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01856829
Effect of Omega-3 Phospholipids on Perceptual-cognitive Training
Effect of Omega-3 Phospholipids on Attentional Abilities and Perceptual-cognitive Training
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Quebec
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Montreal, Quebec, 캐나다, H3T1P1
- Visual psychophysics and perception laboratory
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Montréal, Quebec, 캐나다, H3T1P1
- École d'optométrie, Université de Montréal
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: 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.
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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.
다른 이름들:
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실험적: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Speed-thresholds performance
기간: 6 weeks
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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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공동 작업자 및 조사자
수사관
- 연구 의자: Jocelyn Faubert, PhD, École d'optométrie, Université de Montréal
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- NKO-PC_01
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Placebo에 대한 임상 시험
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Newish Biotech (Wuxi) Co., Ltd.아직 모집하지 않음
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Nature's Sunshine Products, Inc.아직 모집하지 않음
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Yale UniversityHartford HealthCare아직 모집하지 않음
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Acesion Pharma모병심방세동(AF)헝가리, 폴란드, 불가리아, 덴마크, 독일, 네덜란드, 이탈리아, 세르비아
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Shanghai Lanyi Therapeutics Co., Ltd.완전한
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University of Texas Southwestern Medical Center아직 모집하지 않음
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Universidad Autonoma de Zacatecas모집하지 않고 적극적으로