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

Not Applicable

Completed

• Conditions: Depression
• Interventions: Dietary Supplement: omega-3 fatty acids supplements (fish oil); Dietary Supplement: Placebo

• Registration Number: NCT01104194
• Lead Sponsor: Leiden University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-14
• Study First Posted: 2010-04-15
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-08
• Last Update Posted: 2011-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fish-oil	omega-3 fatty acids supplements (fish oil)	-
Placebo	Placebo	Olive oil capsules, identical in appearance to fish oil capsules

Primary Outcome Measures

Name	Time	Method
Cognition	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	4 weeks

Secondary Outcome Measures

Name	Time	Method
Mood states	4 weeks	Fatigue, Anger, Tension, Anxiety, Vigor (Profile of Mood States, self-report measure).; Depressive symptoms.

Trial Locations

Locations (1)

Leiden University; 🇳🇱 Leiden, ZH, Netherlands