Effects of Fish-oil on Mood and Cognitive Functions of Healthy Individuals
|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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104194
|Leiden, ZH, Netherlands, 2333 AK|