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Completed

NCT Number: NCT01104194

Effects of 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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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leiden University

Leiden, South Holland, 2333 AK, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

omega-3 fatty acids supplements (fish oil)

Dietary Supplement

1.74g eicosapentaenoic acid (EPA) and 0.25g docosahexaenoic acid (DHA)

Placebo

Dietary Supplement

softgel capsules (identical in appearance to fish oil capsules) containing olive oil. 3 capsules/day, 4 weeks

Primary outcomes

  1. 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.

  2. Heart Rate Variability

    Time frame: 4 weeks

Secondary outcomes

  1. Mood states

    Time frame: 4 weeks

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

    Depressive symptoms.

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 15, 2010
Registry last updated
Jul 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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