Effects of Omega-3 EPA/DHA for Soldiers at Risk for Mood Disorders
Overview
Stress-related disorders are among the most prevalent and expensive medical consequences of participation in military operations. Omega-3 fatty acids EPA/DHA derived from fish oil are known to benefit both neuronal development in the young, and cognition and mood in various populations. It is possible that soldiers receiving Omega-3 EPA/DHA will exhibit significantly higher cognitive performance, better affect/mood state, and less combat stress symptomatology compared to the placebo after 12 weeks of supplementation. A goal would be to reduce the prevalence of combat stress injuries in military personnel.
Full Title of Study: “Effects of Omega-3 EPA/DHA for Soldiers at Risk for Mood Disorders: A Mood Resilience Trial”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Supportive Care
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: February 2011
Interventions
- Drug: Lovaza, omega-3 fatty acid ethyl ester
- Three 1g capsules/day for three months; this corresponds to a total of 2520mg EPA+DHA/day
- Drug: Placebo, visually identical to Lovaza
- Three 1g corn oil capsules/day for three months
Arms, Groups and Cohorts
- Active Comparator: Lovaza, omega-3 fatty acid ethyl ester
- Placebo Comparator: Placebo
- one gram corn oil in a soft gelatin capsule
Clinical Trial Outcome Measures
Primary Measures
- primary psychometric assessment battery
- Time Frame: 3 months
- Specific components include: Zung Depression Scale (ZDS) Zung Anxiety Scale (ZAS) Pittsburgh Sleep Quality Index (PSQI) Epworth Sleepiness Scale (ESS)
- omega-3 fatty acid status
- Time Frame: 3 months
- finger-prick blood spot is collected for determination of fatty acid composition and profile.
Secondary Measures
- secondary psychometric assessment battery
- Time Frame: 3 months
- This battery will generate index scores in the area of: Memory, Psychomotor Speed, Reaction Time, Cognitive Flexibility, and Complex Attention. It will also include the Alcohol Use Identification Test (AUdIT). Military-specific components include Post-Deployment Health Assessment (PDHA), Neurobehavioral Symptom Inventory (NSI), Combat Exposure Scale (CES), and parts of the Deployment Risk and Resilience Inventory (edited).
Participating in This Clinical Trial
Inclusion Criteria
- US Army deployed personnel – score on a mood questionnaire Exclusion Criteria:
- currently consume omega-3 fish oil supplements – are currently taking antidepressant or other medications for psychiatric purposes – pregnant – known fish or shellfish allergy
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 55 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- United States Department of Defense
- Collaborator
- GlaxoSmithKline
- Provider of Information About this Clinical Study
- Daniel T. Johnston, MD, MPH, LTC, US Army MC,, 1st CAB, US ARMY
- Overall Official(s)
- Daniel T Johnston, MD, MPH, Principal Investigator, United States Department of Defense
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