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

Study Overview
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Brief Summary
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Dietary Supplement: omega-3 fatty acids supplements (fish oil)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fish-oil<br> | Dietary Supplement: omega-3 fatty acids supplements (fish oil)<br>* 1.74g eicosapentaenoic acid (EPA) and 0.25g docosahexaenoic acid (DHA)<br>|
| Placebo Comparator: Placebo<br>Olive oil capsules, identical in appearance to fish oil capsules | Dietary Supplement: Placebo<br>* softgel capsules (identical in appearance to fish oil capsules) containing olive oil. 3 capsules/day, 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognition | 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. | 4 weeks | 
| Heart Rate Variability |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood states | Fatigue, Anger, Tension, Anxiety, Vigor (Profile of Mood States, self-report measure). Depressive symptoms. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, cognition, heart rate variability, omega-3 fatty acids, Depression (in remission) (vulnerability to depression)