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

This study has been completed.
Sponsor:
Collaborator:
Ginsana SA
Information provided by:
Northumbria University
ClinicalTrials.gov Identifier:
NCT01075932
First received: February 24, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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 Intervention
Cerebral Blood Flow
Cognitive Function
Dietary Supplement: DHA-rich fish oil
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Cognitive And Cerebral Hemodynamic Effects Of DHA-Rich Fish Oil: A Dose-Ranging Study

Resource links provided by NLM:


Further study details as provided by Northumbria University:

Primary Outcome Measures:
  • Cerebral blood flow [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Cerebral blood flow will be assessed using Near Infrared Spectroscopy while participants complete a series of cognitive tasks.


Secondary Outcome Measures:
  • Cognitive function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Cognitive function will be assessed using a series of tasks that evaluate working memory, attention and executive function.


Enrollment: 65
Study Start Date: April 2009
Study Completion Date: August 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075932

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

Additional Information:
No publications provided by Northumbria University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Philippa Jackson, Northumbria University
ClinicalTrials.gov Identifier: NCT01075932     History of Changes
Other Study ID Numbers: 16N2
Study First Received: February 24, 2010
Last Updated: February 24, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Northumbria University:
cerebral blood flow
NIRS
n-3 PUFAs
fish oil
cognitive function

ClinicalTrials.gov processed this record on November 27, 2014