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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

April 12, 2010
July 8, 2011
September 2008
September 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01104194 on ClinicalTrials.gov Archive Site
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.

Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
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.

Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01104194
P07.063
No
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