Effects of Fish-oil on Mood and Cognitive Functions of Healthy Individuals

July 8, 2011 updated by: Leiden University Medical Center

The Effects of Omega-3 Fatty Acids Dietary Supplements (Fish-oil) on Mood and Cognitive Functions of Healthy Individuals

The investigators recently found a positive effect of omega-3 supplements on cognitive function in healthy individuals after 4 weeks (J of Psychopharmacology 2009, 23: 831-840). The investigators hypothesize that 4 weeks consumption of omega-3 supplements in previously depressed individuals will positively affect their cognitive functions.

Secondly, low Heart Rate Variability (HRV) is a risk factor for cardiovascular disease. Some studies have found low HRV in patients with depression. No studies have investigated the effects of omega-3 fatty acid supplements on Heart Rate Variability in individuals with a history of depression. The investigators will test the hypotheses that omega-3 supplements lead to an improvement of heart rate variability indices in healthy volunteers with a history of depression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • ZH
      • Leiden, ZH, Netherlands, 2333 AK
        • Leiden University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Dutch-speaking men and women
  • Normal weight (BMI between 18 and 27).
  • Regular diets, not containing fish more than once a week.
  • History of depression (at least one major depressive episode in the past).

Exclusion Criteria:

  • Currently more than mildly depressed (BDI-II-NL score higher than 19, or score on the suicidality item of this scale higher than 1).
  • Current or past psychosis
  • Current substance abuse or past substance dependence
  • Smoking or current use of soft drugs (current = month prior to study till completion)
  • Any hard drug use (lifetime)
  • More than 3 alcoholic consumptions/day

Participants will be asked to keep their dietary habits constant throughout the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fish-oil
Dietary supplement: omega-3 fatty acids supplements (fish oil)
1.74g eicosapentaenoic acid (EPA) and 0.25g docosahexaenoic acid (DHA)
Placebo Comparator: Placebo
Olive oil capsules, identical in appearance to fish oil capsules
Dietary supplement: Placebo
softgel capsules (identical in appearance to fish oil capsules) containing olive oil. 3 capsules/day, 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability
Time Frame: 4 weeks
4 weeks
Cognition
Time Frame: 4 weeks
Battery of test measuring emotional and neutral information processing. Largest effect expected on Decision Making Test (cf. Antypa et al., 2009) and Emotion Recognition Test.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mood states
Time Frame: 4 weeks

Fatigue, Anger, Tension, Anxiety, Vigor (Profile of Mood States, self-report measure).

Depressive symptoms.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

April 12, 2010

First Submitted That Met QC Criteria

April 14, 2010

First Posted (Estimate)

April 15, 2010

Study Record Updates

Last Update Posted (Estimate)

July 11, 2011

Last Update Submitted That Met QC Criteria

July 8, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P07.063

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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