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

NCT ID: NCT01104194

Last Updated: 2011-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-09-30

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.

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Fish-oil

Group Type EXPERIMENTAL

omega-3 fatty acids supplements (fish oil)

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Olive oil capsules, identical in appearance to fish oil capsules

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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omega-3 fatty acids supplements (fish oil)

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Leiden University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Leiden University

Locations

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Leiden University

Leiden, South Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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P07.063

Identifier Type: -

Identifier Source: org_study_id

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