Effects of Fish-oil on Mood and Cognitive Functions of Healthy Individuals
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|ClinicalTrials.gov Identifier: NCT01104194|
Recruitment Status : Completed
First Posted : April 15, 2010
Last Update Posted : July 11, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Depression||Dietary Supplement: omega-3 fatty acids supplements (fish oil) Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||The Effects of Omega-3 Fatty Acids Dietary Supplements (Fish-oil) on Mood and Cognitive Functions of Healthy Individuals|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
Dietary Supplement: omega-3 fatty acids supplements (fish oil)
1.74g eicosapentaenoic acid (EPA) and 0.25g docosahexaenoic acid (DHA)
Placebo Comparator: Placebo
Olive oil capsules, identical in appearance to fish oil capsules
Dietary Supplement: Placebo
softgel capsules (identical in appearance to fish oil capsules) containing olive oil. 3 capsules/day, 4 weeks
- Cognition [ Time Frame: 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 [ Time Frame: 4 weeks ]
- Mood states [ Time Frame: 4 weeks ]
Fatigue, Anger, Tension, Anxiety, Vigor (Profile of Mood States, self-report measure).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104194
|Leiden, ZH, Netherlands, 2333 AK|