Cerebral Blood FlowNCT01075932
Effects of Docosahexaenoic Acid (DHA)-Rich Fish Oil on Cerebral Haemodynamics
A study testing DHA-rich fish oil in people with Cerebral Blood Flow and Cognitive Function, run by Northumbria University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Blood Flow, Cognitive Function
- What is being tested?
- DHA-rich fish oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2009to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male/Female
- 18-35 years
- Healthy
- No herbal supplements/prescription medications (excl. contraceptive pill)
- Non smoker
- Native English speaker
Who cannot join
- consumes oily fish
- takes omega-3 supplement
- food allergies to treatment ingredients
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
About this study
Official title: 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.
- Conditions
- Cerebral Blood Flow, Cognitive Function
- Being tested
- DHA-rich fish oil, Placebo
- Keywords
- cerebral blood flow, NIRS, n-3 PUFAs, fish oil, cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDietary supplement
2 g placebo (olive oil) taken daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: DHA-rich fish oil |
| Placebo | Placebo comparator | 2 g olive oil Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow
Cerebral blood flow will be assessed using Near Infrared Spectroscopy while participants complete a series of cognitive tasks.
Measured: 12 weeks
Secondary outcomes (1)
Cognitive function
Cognitive function will be assessed using a series of tasks that evaluate working memory, attention and executive function.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startApr 2009
- Primary completionMay 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Blood FlowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Ginsana SA
- Investigators
- Philippa A Jackson, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075932
- Sponsor's protocol ID
- 16N2
- Status last verified
- Feb 2010
- First submitted
- 24 Feb 2010
- Last updated
- 25 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22020134
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cognitive And Cerebral Hemodynamic Effects Of DHA-Rich Fish Oil: A Dose-Ranging Study
- ClinicalTrials.gov ID
- NCT01075932
- Acronym / sponsor ID
- 16N2
- Conditions
- Cerebral Blood Flow, Cognitive Function
- Keywords
- cerebral blood flow, NIRS, n-3 PUFAs, fish oil, cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Ginsana SA
- Study start
- Apr 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 25 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 g DHA-rich fish oil | Active comparator | Dietary Supplement: DHA-rich fish oil1 g DHA-rich fish oil containing 450 mg DHA + 90 mg EPA plus 1 g olive oil |
| 2 g DHA-rich fish oil | Active comparator | Dietary Supplement: DHA-rich fish oil2 g DHA-rich fish oil containing 900 mg DHA + 180 mg EPA |
| Placebo | Placebo comparator | Dietary Supplement: Placebo2 g olive oil |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male/Female
- 18-35 years
- Healthy
- No herbal supplements/prescription medications (excl. contraceptive pill)
- Non smoker
Key exclusion criteria (3 listed)
- consumes oily fish
- takes omega-3 supplement
- food allergies to treatment ingredients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHA-rich fish oilEither 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. | Dietary supplement | 1 g DHA-rich fish oil, 2 g DHA-rich fish oil |
| Placebo2 g placebo (olive oil) taken daily for 12 weeks | Dietary supplement | Placebo |
Primary outcome
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.
1 secondary outcome
Cognitive function
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2010.
- Derived from this study: PubMed 22020134Jackson 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.
- Brain, Performance and Nutrition Research Centre, Northumbria UniversityLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippa A Jackson principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DHA-rich fish oil in people with Cerebral Blood Flow and Cognitive Function, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral blood flow (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01075932, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2010.