Skip to main content
OpenTrials
Completed

NCT Number: NCT02763514

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

25 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3 g PronovaPure 150:500 EE EU

Dietary Supplement

3 g PronovaPure 500:200 EE EU

Dietary Supplement

3 g Placebo

Dietary Supplement

Primary outcomes

  1. 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

  2. Subjective fatigue

    Time frame: 26 weeks

    Subjective fatigue will be derived from the Fatigue subscale of the Profile of Mood States questionnaire

Secondary outcomes

  1. 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

  2. Subjective vigour

    Time frame: 26 weeks

    Subjective vigour will be derived from the Vigour subscale of the Profile of Mood States questionnaire

  3. Subjective confusion

    Time frame: 26 weeks

    Subjective confusion will be derived from the Confusion subscale of the Profile of Mood States questionnaire

  4. Subjective anger

    Time frame: 26 weeks

    Subjective anger will be derived from the Anger subscale of the Profile of Mood States questionnaire

  5. Subjective tension

    Time frame: 26 weeks

    Subjective tension will be derived from the Tension subscale of the Profile of Mood States questionnaire

  6. Subjective alertness

    Time frame: 26 weeks

    Subjective alertness will be derived from an Alertness visual analogue scale presented following cognitive task performance

  7. 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

  8. Numeric Working memory

    Time frame: 26 weeks

    Reaction time (ms)

  9. Numeric Working memory

    Time frame: 26 weeks

    Accuracy (%)

  10. Simple reaction time

    Time frame: 26 weeks

  11. Stroop task

    Time frame: 26 weeks

    Reaction time (ms)

  12. Stroop task

    Time frame: 26 weeks

    Accuracy (%)

  13. Rapid visual information processing

    Time frame: 26 weeks

    Reaction time (ms)

  14. Rapid visual information processing

    Time frame: 26 weeks

    Accuracy (%)

  15. Verbal fluency

    Time frame: 26 weeks

    Number correct

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Collaborators

  • Pronova BioPharma

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 5, 2016
Registry last updated
Jan 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.