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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01075932
Other study ID # 16N2
Secondary ID
Status Completed
Phase N/A
First received February 24, 2010
Last updated February 24, 2010
Start date April 2009
Est. completion date August 2009

Study information

Verified date February 2010
Source Northumbria University
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date August 2009
Est. primary completion date May 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 35 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

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
2 g placebo (olive oil) taken daily for 12 weeks

Locations

Country Name City State
United Kingdom Northumbria University Newcastle upon Tyne Tyne and Wear

Sponsors (2)

Lead Sponsor Collaborator
Northumbria University Ginsana SA

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cerebral blood flow Cerebral blood flow will be assessed using Near Infrared Spectroscopy while participants complete a series of cognitive tasks. 12 weeks No
Secondary Cognitive function Cognitive function will be assessed using a series of tasks that evaluate working memory, attention and executive function. 12 weeks No
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