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Phase 2 N=68 Randomized Triple-blind Treatment

Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention

Stress-related Changes in Inflammation

Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Serum ln(IL-6) — 0.054; 0.051 ln(pg/mL) — p=0.97

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
omega-3 supplementation (Dietary_supplement); Oral omega-3 fish oil placebo (Dietary_supplement)
Age
Adult · 18+ yrs
Sex
All
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Primary completion
Dec 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Serum ln(IL-6)
0.054; 0.051 0.97
PRIMARY
Serum ln(TNF-a)
0.61; 0.54 0.06
PRIMARY
Stimulated ln(IL-6)
11.1; 10.9 0.04 sig
PRIMARY
Stimulated ln(TNF-alpha)
7.4; 7.3 0.08
SECONDARY
ln(Beck Anxiety Score)
1.2; 0.93 0.04 sig
SECONDARY
ln(CES-D)
1.6; 1.6 0.93

Summary

This study is designed to examine the effects of fish oil on immune function and mood in medical students.

Eligibility Criteria

Inclusion Criteria

  • OSU preclinical medical or dental student, or graduate nursing student
  • male or female

Exclusion Criteria

  • taking certain medications with immune or endocrine effects
  • chronic health conditions
  • smoking
  • excessive use of alcohol or caffeine
  • significant digestive problems
  • routine use of fish oil or flaxseed supplements or high fish intake
  • fish allergy
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00519779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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