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临床试验/NCT03781557
NCT03781557Unknown4 期

Effect of Omega-3 in Cognition of Young Healthy Adult

Sulaiman AlRajhi Colleges0 个研究点目标入组 60 人开始时间: 2019年1月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
发起方
入组人数
60
主要终点
Attention

研究概览

简要总结

In this trial, the investigators are going to investigate the improvement of cognitive brain domains after ingestion of omega 3 products that have high concentrations of DHA, Docosahexaenoic acid, and EPA, Eicosapentaenoic acid, in comparison to control group young healthy adults. The study will assess the improvement by computerized testing by their reaction time before and after the intervention. The researchers will follow the scientific and ethical regulations prevent any harmful effect on recruited subjects.

详细描述

Research Question :

Research question: Will daily consumption of omega-3 fish oil improve brain cognitive domains?

Study Methodology Research Design:

A placebo-controlled, double-blinded, 3-armed randomized controlled trial.

Population and Sample :

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Young Adult (18-25)

排除标准

  • Diet rich in fish oil: subjects should not use a diet rich in omega 3 poly-unsaturated fatty acids, that is defined as more than one portion a week or more than 4 portions a month of the following food items
  • Salmon Sardines • Flaxseed oil or whole flaxseed Illicit drug use
  • Medications of mental illnesses or that affect brain functions
  • Fish Allergy

研究组 & 干预措施

Olive Oil

Placebo Comparator

Olive Oil softgels

干预措施: Olive oil (Dietary Supplement)

High-concentrated EPA

Experimental

High-concentrated EPA fish oil softgels

干预措施: Eicosapentaenoic acid (Dietary Supplement)

High-concentrated DHA

Experimental

High-concentrated DHA fish oil softgels

干预措施: Docosahexaenoic acid (Dietary Supplement)

结局指标

主要结局

Attention

时间窗: 5 minutes

it will be measured by Psytest (TAP 2.3.1) computerised test to assess the reaction time related to it by milliseconds

Working memory

时间窗: 5 minutes

Working memory can be looked at as a system that keeps the information essential for solving difficult dilemmas and processing multi-level tasks or aspects of a situation in order to bring about a final impression. it will be measured by Psytest (TAP 2.3.1) computerised test to assess the reaction time related to it by milliseconds.

Go/ No go

时间窗: 5 minutes

this test will measure the specific ability of the subject to suppress an inappropriate response and to react only on the appearance of some stimuli and not in the presence of others, which requires significant central intervention. it will be measured by Psytest (TAP 2.3.1) computerised test to assess the reaction time related to it by milliseconds.

Divided attention

时间窗: 10 minutes

In this test, an auditory and a visual task must be taken simultaneously, to measure the subject's ability to carry out more than one task at the same time. it will be measured by Psytest (TAP 2.3.1) computerised test to assess the reaction time related to it by milliseconds.

Sustained attention

时间窗: 15 minutes

it will be measured by Psytest (TAP 2.3.1) computerised test to assess the reaction time related to it by milliseconds.

stimulus-reaction incompatibility (Simon effect)

时间窗: 3 minutes

Incompatibility occurs in a conflict situation in which divergent stimulus information has to be processed in parallel, thus triggering different reaction tendencies. The Simon and the Stroop effects (in the Colour-Word Interference Test) are classic examples of this effect. The present procedure tests the interference tendency in terms of stimulus-reaction incompatibility (Simon effect) . For this test, arrows that are directed to the left or the right are presented on the left or the right of a fixation point. Depending on the direction of the arrow, the test person should respond with the right or left hand irrespective of the side on which the arrow is presented.

Alertness

时间窗: 5 minutes

In this test, we will measure the reaction time. Simple reaction time measurements will be done, in which a diamond appears on the screen at random intervals and to which the subject should respond as quickly as possible by pressing a button. it will be measured by Psytest (TAP 2.3.1) computerised test to assess the reaction time related to it by milliseconds.

次要结局

未报告次要终点

研究者

发起方
Sulaiman AlRajhi Colleges
申办方类型
Other
责任方
Sponsor

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