Cognitive and Mood Effects of Docosahexaenoic Acid (DHA)-Rich and Eicosapentaenoic Acid (EPA)-Rich Fish Oil in Healthy Young Adults

• Sponsor: Northumbria University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01075919
• Collaborator: Ginsana SA (Other)
• Enrollment: 159
• Location: 1
• Arms: 3
• Duration (Months): 12
• Patients Per Site Per Month: 13.2

Study Details

Study Description

Brief Summary

To date, only a small handful of studies have assessed the effects of omega-3 polyunsaturated fatty acids (n-3 PUFAs) on cognitive function in healthy adults. The results from these studies are mixed, and have differed greatly in terms of methodology as regards sample size, treatment formulation and duration of the intervention. In order to address these issues, the present study aims to assess the effects of two different formulations of fish oil in parallel, and at doses consistent with the current recommended daily intake of oily fish, across a range of cognitive domains. The aim of the present investigation is therefore to specifically evaluate the effects of 12 weeks supplementation of DHA-rich fish oil and EPA-rich fish oil dietary supplements on cognitive function in healthy young adults maintaining a regular diet containing oily fish not more than once a week. Self-report mood assessments will form the secondary part of this investigation.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Function; Mood	Dietary Supplement: n-3 PUFAs; Dietary Supplement: Placebo; Dietary Supplement: n-3 PUFAs	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 159 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Cognitive and Mood Effects of DHA-rich and EPA-rich Fish Oil in Healthy Young Adults
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: DHA-rich fish oil 1 g DHA-rich fish oil containing 450 mg DHA + 90 mg EPA	Dietary Supplement: n-3 PUFAs; 1 g DHA-rich fish oil taken daily for 12 weeks
Active Comparator: EPA-rich fish oil 1 g EPA-rich fish oil containing 300 mg EPA + 200 mg DHA	Dietary Supplement: n-3 PUFAs; 1 g EPA-rich fish oil taken daily for 12 weeks
Placebo Comparator: Placebo 1 g Olive oil	Dietary Supplement: Placebo; 1 g olive oil taken daily for 12 weeks

Outcome Measures

Primary Outcome Measures

1. Cognitive performance [12 weeks]

   Performance is assessed using the COMPASS (Computerised Mental Performance Assessment) system, which presents a battery of standard cognitive tasks assessing aspects of attention, memory and executive function. The Cognitive Demand Battery (30 minutes)will also be administered and assesses cognitive performance under mental fatigue.

Secondary Outcome Measures

1. Mood [12 weeks]

   Mood will be evaluated using Bond-Lader VAS and the Depression, Anxiety and Stress Scales.

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 ≥ 1 portion oily fish/week

• 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: NCT01075919
• Other Study ID Numbers: 16N1
• First Posted: Feb 25, 2010
• Last Update Posted: Feb 25, 2010
• Last Verified: Feb 1, 2010

• Keywords provided by , ,: n-3 PUFAs; Cognitive function; Healthy young adults; Fish oil; Mood

Study Results

No Results Posted as of Feb 25, 2010