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

This study has been completed.
Sponsor:
Information provided by:
Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT01104194
First received: April 12, 2010
Last updated: July 8, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Depression
 Dietary Supplement: omega-3 fatty acids supplements (fish oil)
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: Treatment
Official Title: The Effects of Omega-3 Fatty Acids Dietary Supplements (Fish-oil) on Mood and Cognitive Functions of Healthy Individuals

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • Cognition [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mood states [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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

    Depressive symptoms.



Estimated Enrollment: 60
Study Start Date: September 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104194

Locations
Netherlands
Leiden University
Leiden, ZH, Netherlands, 2333 AK
Sponsors and Collaborators
Leiden University Medical Center
  More Information

No publications provided

Responsible Party: Prof AJW Van der Does, Leiden University
ClinicalTrials.gov Identifier: NCT01104194     History of Changes
Other Study ID Numbers: P07.063
Study First Received: April 12, 2010
Last Updated: July 8, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Leiden University Medical Center:
depression
cognition
heart rate variability
omega-3 fatty acids
Depression (in remission) (vulnerability to depression)

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013