NCT01075919

Brief Summary

To date, only a small handful of studies have assessed the effects of omega-3 polyunsaturated fatty acids (n-3 PUFAs) on cognitive function in healthy adults. The results from these studies are mixed, and have differed greatly in terms of methodology as regards sample size, treatment formulation and duration of the intervention. In order to address these issues, the present study aims to assess the effects of two different formulations of fish oil in parallel, and at doses consistent with the current recommended daily intake of oily fish, across a range of cognitive domains. The aim of the present investigation is therefore to specifically evaluate the effects of 12 weeks supplementation of DHA-rich fish oil and EPA-rich fish oil dietary supplements on cognitive function in healthy young adults maintaining a regular diet containing oily fish not more than once a week. Self-report mood assessments will form the secondary part of this investigation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2007

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

Study Start

First participant enrolled

December 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2010

Completed
Last Updated

February 25, 2010

Status Verified

February 1, 2010

Enrollment Period

1 year

First QC Date

February 24, 2010

Last Update Submit

February 24, 2010

Conditions

Keywords

n-3 PUFAsCognitive functionHealthy young adultsFish oilMood

Outcome Measures

Primary Outcomes (1)

  • Cognitive performance

    Performance is assessed using the COMPASS (Computerised Mental Performance Assessment) system, which presents a battery of standard cognitive tasks assessing aspects of attention, memory and executive function. The Cognitive Demand Battery (30 minutes)will also be administered and assesses cognitive performance under mental fatigue.

    12 weeks

Secondary Outcomes (1)

  • Mood

    12 weeks

Study Arms (3)

DHA-rich fish oil

ACTIVE COMPARATOR

1 g DHA-rich fish oil containing 450 mg DHA + 90 mg EPA

Dietary Supplement: n-3 PUFAs

EPA-rich fish oil

ACTIVE COMPARATOR

1 g EPA-rich fish oil containing 300 mg EPA + 200 mg DHA

Dietary Supplement: n-3 PUFAs

Placebo

PLACEBO COMPARATOR

1 g Olive oil

Dietary Supplement: Placebo

Interventions

n-3 PUFAsDIETARY_SUPPLEMENT

1 g DHA-rich fish oil taken daily for 12 weeks

DHA-rich fish oil
PlaceboDIETARY_SUPPLEMENT

1 g olive oil taken daily for 12 weeks

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male/Female
  • years
  • Healthy
  • No herbal supplements/prescription medications (excl. contraceptive pill)
  • Non smoker
  • Native English speaker

You may not qualify if:

  • Consumes ≥ 1 portion oily fish/week
  • takes omega-3 supplement
  • Food allergies to treatment ingredients

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 Links

Study Officials

  • Philippa A Jackson

    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

Study Record Dates

First Submitted

February 24, 2010

First Posted

February 25, 2010

Study Start

December 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

February 25, 2010

Record last verified: 2010-02

Locations