NCT01075932

Brief Summary

DHA has previously been shown to increase regional cerebral blood flow response to tactile stimulation in aged monkeys; modulation of cerebral blood flow in humans has yet to be demonstrated. Given that the brain relies on a constant supply of blood-borne metabolic substrates (e.g. glucose, oxygen), increasing regional cerebral blood flow may also have an impact on cognitive function. The current study aims to investigate the effects of two doses of DHA-rich fish oil on task-related cerebral hemodynamic response and cognitive performance in healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2009

Shorter than P25 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

Study Start

First participant enrolled

April 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
7 months 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 month

First QC Date

February 24, 2010

Last Update Submit

February 24, 2010

Conditions

Keywords

cerebral blood flowNIRSn-3 PUFAsfish oilcognitive function

Outcome Measures

Primary Outcomes (1)

  • Cerebral blood flow

    Cerebral blood flow will be assessed using Near Infrared Spectroscopy while participants complete a series of cognitive tasks.

    12 weeks

Secondary Outcomes (1)

  • Cognitive function

    12 weeks

Study Arms (3)

1 g DHA-rich fish oil

ACTIVE COMPARATOR

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

Dietary Supplement: DHA-rich fish oil

2 g DHA-rich fish oil

ACTIVE COMPARATOR

2 g DHA-rich fish oil containing 900 mg DHA + 180 mg EPA

Dietary Supplement: DHA-rich fish oil

Placebo

PLACEBO COMPARATOR

2 g olive oil

Dietary Supplement: Placebo

Interventions

DHA-rich fish oilDIETARY_SUPPLEMENT

Either 1 g or 2 g DHA-rich fish oil taken daily for 12 weeks. Participants in the 1 g group will also consume 1 g olive oil placebo capsules per day to maintain double blind.

1 g DHA-rich fish oil2 g DHA-rich fish oil
PlaceboDIETARY_SUPPLEMENT

2 g placebo (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 oily fish
  • 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 Publications (1)

  • Jackson PA, Reay JL, Scholey AB, Kennedy DO. Docosahexaenoic acid-rich fish oil modulates the cerebral hemodynamic response to cognitive tasks in healthy young adults. Biol Psychol. 2012 Jan;89(1):183-90. doi: 10.1016/j.biopsycho.2011.10.006. Epub 2011 Oct 19.

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

April 1, 2009

Primary Completion

May 1, 2009

Study Completion

August 1, 2009

Last Updated

February 25, 2010

Record last verified: 2010-02

Locations