Effects of Fish-oil on Mood and Cognitive Functions of Healthy Individuals
NCT ID: NCT01104194
Last Updated: 2011-07-11
Study Results
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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COMPLETED
NA
60 participants
INTERVENTIONAL
2008-09-30
2010-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Fish-oil
omega-3 fatty acids supplements (fish oil)
1.74g eicosapentaenoic acid (EPA) and 0.25g docosahexaenoic acid (DHA)
Placebo
Olive oil capsules, identical in appearance to fish oil capsules
Placebo
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)
Placebo
softgel capsules (identical in appearance to fish oil capsules) containing olive oil. 3 capsules/day, 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
ALL
Yes
Sponsors
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Leiden University Medical Center
OTHER
Responsible Party
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Leiden University
Locations
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Leiden University
Leiden, South Holland, Netherlands
Countries
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Other Identifiers
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P07.063
Identifier Type: -
Identifier Source: org_study_id
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