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

This study has been completed.
Sponsor:
Collaborator:
Ginsana SA
Information provided by:
Northumbria University
ClinicalTrials.gov Identifier:
NCT01075919
First received: February 24, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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 Intervention
Cognitive Function
Mood
Dietary Supplement: n-3 PUFAs
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Northumbria University:

Primary Outcome Measures:
  • Cognitive performance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Mood [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Mood will be evaluated using Bond-Lader VAS and the Depression, Anxiety and Stress Scales.


Enrollment: 159
Study Start Date: December 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075919

Locations
United Kingdom
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
  More Information

Additional Information:
No publications provided

Responsible Party: Philippa Jackson, Northumbria University
ClinicalTrials.gov Identifier: NCT01075919     History of Changes
Other Study ID Numbers: 16N1
Study First Received: February 24, 2010
Last Updated: February 24, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Northumbria University:
n-3 PUFAs
Cognitive function
Healthy young adults
Fish oil
Mood

ClinicalTrials.gov processed this record on November 19, 2014