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

• Sponsor: Northumbria University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01075932
• Collaborator: Ginsana SA (Other)
• Enrollment: 65
• Location: 1
• Arms: 3
• Duration (Months): 4
• Patients Per Site Per Month: 16.2

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Apr 1, 2009
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

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

Primary Outcome Measures

1. Cerebral blood flow [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 [12 weeks]

   Cognitive function will be assessed using a series of tasks that evaluate working memory, attention and executive function.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Brain, Performance and Nutrition Research Centre, Northumbria University

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01075932
• Other Study ID Numbers: 16N2
• First Posted: Feb 25, 2010
• Last Update Posted: Feb 25, 2010
• Last Verified: Feb 1, 2010

• Keywords provided by , ,: cerebral blood flow; NIRS; n-3 PUFAs; fish oil; cognitive function

Study Results

No Results Posted as of Feb 25, 2010