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

L

Leiden University Medical Center (LUMC)

Status

Completed

Conditions

Depression

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01104194
P07.063

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups, including a placebo group

Fish-oil
Experimental group
Treatment:
Dietary Supplement: omega-3 fatty acids supplements (fish oil)
Placebo
Placebo Comparator group
Description:
Olive oil capsules, identical in appearance to fish oil capsules
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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