Effects of Omega-3 Fatty Acids Supplement in Cognition of Young Healthy Adults and in Their Reaction Time of Computerized Test After 3 Months of Taking High-concentrated DHA and EPA Fish Softgels

NCT03781557 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: SulimanAC-Omega-3
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cognition; Brain; Neuroscience

Keywords

Omega-3; DHA fatty acids; EPA fatty acids; Cognition; Brain; Healthy Adult; Fish Oil; Human

Outcome Measures

Primary Outcomes (7)

• Attention

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

  5 minutes

• Working memory

  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.

  5 minutes

• Sustained attention

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

  15 minutes

• stimulus-reaction incompatibility (Simon effect)

  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.

  3 minutes

• Go/ No go

  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.

  5 minutes

• Divided attention

  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.

  10 minutes

• Alertness

  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.

  5 minutes

Study Arms (3)

High-concentrated DHA

EXPERIMENTAL

High-concentrated DHA fish oil softgels

Dietary Supplement: Docosahexaenoic acid

High-concentrated EPA

EXPERIMENTAL

High-concentrated EPA fish oil softgels

Dietary Supplement: Eicosapentaenoic acid

Olive Oil

PLACEBO COMPARATOR

Olive Oil softgels

Dietary Supplement: Olive oil

Interventions

Docosahexaenoic acid DIETARY_SUPPLEMENT

High-concentrated DHA

Also known as: MadreLabs, DHA 700 Fish Oil

High-concentrated DHA

Eicosapentaenoic acid DIETARY_SUPPLEMENT

High-concentrated EPA

Also known as: Sports Research, Omega-3 Fish Oil, Triple Strength

High-concentrated EPA

Olive oil DIETARY_SUPPLEMENT

Olive Oil softgels

Olive Oil

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy
• Young Adult (18-25)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sulaiman AlRajhi Colleges: lead

MeSH Terms

Interventions

Docosahexaenoic Acids; Eicosapentaenoic Acid; Fish Oils; Olive Oil

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils; Eicosanoids; Fats, Unsaturated; Plant Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

WESAM ALKASSAS, MBBS

CONTACT

+966538975400; 13110021@srcolleges.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 20, 2018
• Study Start: January 1, 2019
• Primary Completion: April 1, 2019
• Study Completion: May 29, 2019
• Last Updated: December 20, 2018

Record last verified: 2018-12