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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01104194
• Other study ID #: P07.063
• Status: Completed
• Phase: N/A
• First received: April 12, 2010
• Last updated: July 8, 2011
• Start date: September 2008
• Est. completion date: September 2010

Study information

• Verified date: July 2011
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Netherlands	Leiden University	Leiden	ZH

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Heart Rate Variability		4 weeks	No
Secondary	Mood states	Fatigue, Anger, Tension, Anxiety, Vigor (Profile of Mood States, self-report measure).; Depressive symptoms.	4 weeks	No