NCT02763514

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
337

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

January 24, 2019

Status Verified

January 1, 2019

Enrollment Period

2.2 years

First QC Date

April 20, 2016

Last Update Submit

January 22, 2019

Conditions

Cognitive Function

Outcome Measures

Primary Outcomes (2)

  • Episodic memory

    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

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

    26 weeks

Secondary Outcomes (15)

  • Subjective overall mood disturbance

    26 weeks

  • Subjective vigour

    26 weeks

  • Subjective confusion

    26 weeks

  • Subjective anger

    26 weeks

  • Subjective tension

    26 weeks

  • +10 more secondary outcomes

Other Outcomes (1)

  • Omega-3 index

    26 weeks

Study Arms (3)

DHA-enriched oil

ACTIVE COMPARATOR

3 g PronovaPure 150:500 EE EU

Dietary Supplement: 3 g PronovaPure 150:500 EE EU

EPA-enriched oil

ACTIVE COMPARATOR

3 g PronovaPure 500:200 EE EU

Dietary Supplement: 3 g PronovaPure 500:200 EE EU

Placebo

PLACEBO COMPARATOR

3 g Olive oil

Dietary Supplement: 3 g Placebo

Interventions

3 g PronovaPure 150:500 EE EUDIETARY_SUPPLEMENT
DHA-enriched oil
3 g PronovaPure 500:200 EE EUDIETARY_SUPPLEMENT
EPA-enriched oil
3 g PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age25 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

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

Location

Related Publications (1)

  • Patan MJ, Kennedy DO, Husberg C, Hustvedt SO, Calder PC, Khan J, Forster J, Jackson PA. Supplementation with oil rich in eicosapentaenoic acid, but not in docosahexaenoic acid, improves global cognitive function in healthy, young adults: results from randomized controlled trials. Am J Clin Nutr. 2021 Sep 1;114(3):914-924. doi: 10.1093/ajcn/nqab174.

    PMID: 34113957DERIVED

Study Officials

  • Philippa Jackson, PhD

    Northumbria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 20, 2016

First Posted

May 5, 2016

Study Start

October 1, 2016

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

January 24, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)