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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01104194
Recruitment Status : Completed
First Posted : April 15, 2010
Last Update Posted : July 11, 2011
Information provided by:
Leiden University Medical Center

April 12, 2010
April 15, 2010
July 11, 2011
September 2008
September 2010   (Final data collection date for primary outcome measure)
  • 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.
  • Heart Rate Variability [ Time Frame: 4 weeks ]
Same as current
Complete list of historical versions of study NCT01104194 on Archive Site
Mood states [ Time Frame: 4 weeks ]
Fatigue, Anger, Tension, Anxiety, Vigor (Profile of Mood States, self-report measure). Depressive symptoms.
Same as current
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Effects of Fish-oil on Mood and Cognitive Functions of Healthy Individuals
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.

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Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Dietary Supplement: omega-3 fatty acids supplements (fish oil)
    1.74g eicosapentaenoic acid (EPA) and 0.25g docosahexaenoic acid (DHA)
  • Dietary Supplement: Placebo
    softgel capsules (identical in appearance to fish oil capsules) containing olive oil. 3 capsules/day, 4 weeks
  • Experimental: Fish-oil
    Intervention: Dietary Supplement: omega-3 fatty acids supplements (fish oil)
  • Placebo Comparator: Placebo
    Olive oil capsules, identical in appearance to fish oil capsules
    Intervention: Dietary Supplement: Placebo
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2010
September 2010   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Not Provided
Prof AJW Van der Does, Leiden University
Leiden University Medical Center
Not Provided
Not Provided
Leiden University Medical Center
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP