Clinical trial NCT00519779: Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention
Official title: Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stress-related Changes in Inflammation
Keywords: affect
inflammation
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
Collaborators: name: Office of Dietary Supplements (ODS)
First posted: 2007-08-23
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: This study will examine how supplementation with omega-3 polyunsaturated fatty acids (key fish oil components) affects immune and mood responses to examination stress. This study will examine these outcomes in medical students during academic examination periods as well as less stressful non-exam periods. Participants will take fish oil supplements or placebo pills for approximately 3 months during which time relevant mood, endocrine, and immune measures will be assessed.

For detailed information about the study, please visit our website at http://www.stressandhealth.org

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

Primary outcomes:
measure: Serum ln(IL-6)
timeFrame: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
measure: Serum ln(TNF-a)
timeFrame: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
measure: Stimulated ln(IL-6)
timeFrame: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
measure: Stimulated ln(TNF-alpha)
timeFrame: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
Secondary outcomes:
measure: ln(Beck Anxiety Score)
timeFrame: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
measure: ln(CES-D)
timeFrame: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Medicine
state: Ohio
Study officials:
affiliation: Ohio State University
name: Janice K Kiecolt-Glaser, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kiecolt-Glaser JK, Belury MA, Andridge R, Malarkey WB, Glaser R. Omega-3 supplementation lowers inflammation and anxiety in medical students: a randomized controlled trial. Brain Behav Immun. 2011 Nov;25(8):1725-34. doi: 10.1016/j.bbi.2011.07.229. Epub 2011 Jul 19.