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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01075919
Other study ID # 16N1
Secondary ID
Status Completed
Phase N/A
First received February 24, 2010
Last updated February 24, 2010
Start date December 2007
Est. completion date December 2008

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

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.


Recruitment information / eligibility

Status Completed
Enrollment 159
Est. completion date December 2008
Est. primary completion date December 2008
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 = 1 portion oily fish/week

- 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:
n-3 PUFAs
1 g DHA-rich fish oil taken daily for 12 weeks
Placebo
1 g olive oil taken daily for 12 weeks
n-3 PUFAs
1 g EPA-rich fish 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 Cognitive performance 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. 12 weeks No
Secondary Mood Mood will be evaluated using Bond-Lader VAS and the Depression, Anxiety and Stress Scales. 12 weeks No
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