The Effects of DHA- and EPA-enriched Oils on Cognitive Function and Mood

January 22, 2019 updated by: Philippa Jackson, Northumbria University

Efficacy Evaluation of 26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Cognitive Function and Mood in Healthy Adults

The purpose of this study is to investigate the effects of EPA- and DHA-enriched omega-3 polyunsaturated fatty acid dietary supplements on cognitive function (episodic memory, attention, working memory, executive function), subjective mood, alertness and mental fatigue after 26 weeks daily supplementation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
337

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Tyne And Wear
      • Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE1 8ST
        • Northumbria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 49 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 25 to 49 years inclusive
  • Males and females
  • Self-report of good health

Exclusion Criteria:

  • English is not first language (some of the cognitive tasks have only been validated in native English speakers)
  • Habitual consumption of oily fish exceeds one fish meal per week
  • Habitual consumption of omega-3 dietary supplements in the previous 6 months
  • Habitual use of dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total; some supplements that do not impact upon cognitive function e.g. garlic, protein, calcium are allowed. Please check with the research team if you are unsure)
  • Are a smoker or consume any nicotine replacement products (e.g. chewing gum, e-cigarettes)
  • Food allergies or sensitivities to any of the ingredients contained in the investigational product or any other foodstuff
  • Pregnant, trying to get pregnant or breast feeding
  • Body Mass Index outside of the range 18-35 kg/m2
  • High blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
  • Currently taking blood pressure medication
  • Currently taking blood thinning medication (e.g. aspirin, warfarin, heparin)
  • Have a respiratory disorder that requires regular medication (Note: participants with asthma who only take their medication occasionally/as required are eligible for this study)
  • Have frequent migraines that require medication (more than or equal to 1 per month)
  • History or current diagnosis of drug/alcohol abuse
  • History of kidney or liver disease, or other severe diseases of the gastrointestinal tract (e.g. iron accumulation, iron utilization disorders, hypercalcaemia, hypercalcaemia), that are likely to interfere with metabolism/absorption/secretion of the product under investigation
  • History of neurological or psychiatric illness (excluding depressive illness and anxiety)
  • History of head trauma
  • Sleep disturbances and/or are taking sleep aid medication
  • Blood disorders (e.g. anaemia, haemophilia, thrombocytosis)
  • Diagnosis of type I or type II diabetes
  • Heart disorder, or vascular illness
  • Current diagnosis of depression and/or anxiety
  • Over- or under-active thyroid
  • Chronic gastrointestinal problems (e.g. Inflammatory Bowel Disease, Irritable Bowel Syndrome, celiac disease)
  • Any known active infections
  • Diagnosed with or may be at risk of having syphilis, hepatitis, the Human T - lymphotropic virus or the Human Immunodeficiency Virus
  • Current or past breast cancer diagnosis and/or a mastectomy
  • Health condition that would prevent fulfilment of the study requirements
  • Currently participating in or in the past 4 weeks participated in other clinical or nutrition intervention studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: DHA-enriched oil
3 g PronovaPure 150:500 EE EU
Dietary supplement: 3 g PronovaPure 150:500 EE EU
ACTIVE_COMPARATOR: EPA-enriched oil
3 g PronovaPure 500:200 EE EU
Dietary supplement: 3 g PronovaPure 500:200 EE EU
PLACEBO_COMPARATOR: Placebo
3 g Olive oil
Dietary supplement: 3 g Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Episodic memory
Time Frame: 26 weeks
An overall score for Episodic memory will be derived by calculating the average score from 6 separate standardised task outcomes (Zimmediate word recall accuracy + Zdelayed word recall accuracy + Zword recognition accuracy + Zpicture recognition accuracy - Zimmediate word recall errors - Zdelayed word recall errors)/6
26 weeks
Subjective fatigue
Time Frame: 26 weeks
Subjective fatigue will be derived from the Fatigue subscale of the Profile of Mood States questionnaire
26 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subjective overall mood disturbance
Time Frame: 26 weeks
Subjective overall mood disturbance is derived from the overall score of the Profile of Mood States questionnaire
26 weeks
Subjective vigour
Time Frame: 26 weeks
Subjective vigour will be derived from the Vigour subscale of the Profile of Mood States questionnaire
26 weeks
Subjective confusion
Time Frame: 26 weeks
Subjective confusion will be derived from the Confusion subscale of the Profile of Mood States questionnaire
26 weeks
Subjective anger
Time Frame: 26 weeks
Subjective anger will be derived from the Anger subscale of the Profile of Mood States questionnaire
26 weeks
Subjective tension
Time Frame: 26 weeks
Subjective tension will be derived from the Tension subscale of the Profile of Mood States questionnaire
26 weeks
Subjective alertness
Time Frame: 26 weeks
Subjective alertness will be derived from an Alertness visual analogue scale presented following cognitive task performance
26 weeks
Subjective mental fatigue
Time Frame: 26 weeks
Subjective mental fatigue will be derived from a Mental Fatigue visual analogue scale presented following cognitive task performance
26 weeks
Numeric Working memory
Time Frame: 26 weeks
Reaction time (ms)
26 weeks
Numeric Working memory
Time Frame: 26 weeks
Accuracy (%)
26 weeks
Simple reaction time
Time Frame: 26 weeks
26 weeks
Stroop task
Time Frame: 26 weeks
Reaction time (ms)
26 weeks
Stroop task
Time Frame: 26 weeks
Accuracy (%)
26 weeks
Rapid visual information processing
Time Frame: 26 weeks
Reaction time (ms)
26 weeks
Rapid visual information processing
Time Frame: 26 weeks
Accuracy (%)
26 weeks
Verbal fluency
Time Frame: 26 weeks
Number correct
26 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Omega-3 index
Time Frame: 26 weeks
Omega-3 index is expressed as the sum of EPA and DHA as a percentage of total red blood cell fatty acids
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northumbria University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pronova BioPharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 44N3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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