- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01075932
Effects of Docosahexaenoic Acid (DHA)-Rich Fish Oil on Cerebral Haemodynamics
February 24, 2010 updated by: Northumbria University
The Cognitive And Cerebral Hemodynamic Effects Of DHA-Rich Fish Oil: A Dose-Ranging Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tyne and Wear
-
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
- Northumbria University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / 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
|
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
|
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
|
2 g placebo (olive oil) taken daily for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive function
Time Frame: 12 weeks
|
Cognitive function will be assessed using a series of tasks that evaluate working memory, attention and executive function.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (ACTUAL)
May 1, 2009
Study Completion (ACTUAL)
August 1, 2009
Study Registration Dates
First Submitted
February 24, 2010
First Submitted That Met QC Criteria
February 24, 2010
First Posted (ESTIMATE)
February 25, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
February 25, 2010
Last Update Submitted That Met QC Criteria
February 24, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- 16N2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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