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Effects of Docosahexaenoic Acid (DHA)-Rich Fish Oil on Cerebral Haemodynamics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01075932
Recruitment Status : Completed
First Posted : February 25, 2010
Last Update Posted : February 25, 2010
Sponsor:
Collaborator:
Ginsana SA
Information provided by:
Northumbria University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cerebral Blood Flow Cognitive Function Dietary Supplement: DHA-rich fish oil Dietary Supplement: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Cognitive And Cerebral Hemodynamic Effects Of DHA-Rich Fish Oil: A Dose-Ranging Study
Study Start Date : April 2009
Actual Primary Completion Date : May 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1 g DHA-rich fish oil
1 g DHA-rich fish oil containing 450 mg DHA + 90 mg EPA plus 1 g olive oil
 Dietary Supplement: DHA-rich fish oil
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.
Active Comparator: 2 g DHA-rich fish oil
2 g DHA-rich fish oil containing 900 mg DHA + 180 mg EPA
 Dietary Supplement: DHA-rich fish oil
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.
Placebo Comparator: Placebo
2 g olive oil
 Dietary Supplement: Placebo
2 g placebo (olive oil) taken daily for 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Cerebral blood flow [ Time Frame: 12 weeks ]
    Cerebral blood flow will be assessed using Near Infrared Spectroscopy while participants complete a series of cognitive tasks.


Secondary Outcome Measures :
  1. Cognitive function [ Time Frame: 12 weeks ]
    Cognitive function will be assessed using a series of tasks that evaluate working memory, attention and executive function.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male/Female
  • 18-35 years
  • Healthy
  • No herbal supplements/prescription medications (excl. contraceptive pill)
  • Non smoker
  • Native English speaker

Exclusion Criteria:

  • consumes oily fish
  • takes omega-3 supplement
  • food allergies to treatment ingredients
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075932


Locations
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United Kingdom
Northumbria University
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
Sponsors and Collaborators
Northumbria University
Ginsana SA
Investigators
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Principal Investigator: Philippa A Jackson Northumbria University
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Philippa Jackson, Northumbria University
ClinicalTrials.gov Identifier: NCT01075932    
Other Study ID Numbers: 16N2
First Posted: February 25, 2010    Key Record Dates
Last Update Posted: February 25, 2010
Last Verified: February 2010
Keywords provided by Northumbria University:
cerebral blood flow
NIRS
n-3 PUFAs
fish oil
cognitive function