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

NCT01104194 | Completed

• 1 other identifier: P07.063
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Keywords

depression; cognition; heart rate variability; omega-3 fatty acids; Depression (in remission) (vulnerability to depression)

Outcome Measures

Primary Outcomes (2)

• 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

• Heart Rate Variability

  4 weeks

Secondary Outcomes (1)

• Mood states

  4 weeks

Study Arms (2)

Fish-oil

EXPERIMENTAL

Dietary Supplement: omega-3 fatty acids supplements (fish oil)

Placebo

PLACEBO COMPARATOR

Olive oil capsules, identical in appearance to fish oil capsules

Dietary Supplement: Placebo

Interventions

omega-3 fatty acids supplements (fish oil) DIETARY_SUPPLEMENT

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

Fish-oil

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University

Leiden, South Holland, 2333 AK, Netherlands

Location

MeSH Terms

Conditions

Depression

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 15, 2010
• Study Start: September 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 11, 2011

Record last verified: 2011-07

Locations

NL (1)