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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01104194
Enrollment
60
Registered
2010-04-15
Start date
2008-09-30
Completion date
2010-09-30
Last updated
2011-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

depression, cognition, heart rate variability, omega-3 fatty acids, Depression (in remission) (vulnerability to depression)

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTomega-3 fatty acids supplements (fish oil)

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

DIETARY_SUPPLEMENTPlacebo

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

Sponsors

Leiden University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Cognition4 weeksBattery 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 Variability4 weeks

Secondary

MeasureTime frameDescription
Mood states4 weeksFatigue, Anger, Tension, Anxiety, Vigor (Profile of Mood States, self-report measure). Depressive symptoms.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026