Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Serum ln(IL-6)
研究概览
简要总结
This study is designed to examine the effects of fish oil on immune function and mood in medical students.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •OSU preclinical medical or dental student, or graduate nursing student
- •male or female
排除标准
- •taking certain medications with immune or endocrine effects
- •chronic health conditions
- •excessive use of alcohol or caffeine
- •significant digestive problems
- •routine use of fish oil or flaxseed supplements or high fish intake
- •fish allergy
结局指标
主要结局
Serum ln(IL-6)
时间窗: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
log-transformed serum Interleukin-6 (IL-6) Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill. Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes.
Serum ln(TNF-a)
时间窗: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha) All cytokine measurements (e.g., IL-6 and TNF-a, serum and stimulated) were analyzed across time; however, no stress effects were found. Therefore, all assessments post-supplementation were averaged (time points 3-6) and analyzed to determine whether fish oil supplementation had an effect. Pooling these 4 assessments provides a better estimate of an individual's cytokine levels because single time point measurements can be affected by changes in exercise, alcohol consumption, or sleep in the preceding 24-48 hours.
Stimulated ln(IL-6)
时间窗: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
log-transformed stimulated IL-6 Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill. Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes.
Stimulated ln(TNF-alpha)
时间窗: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
log-transformed stimulated TNF-alpha
次要结局
- ln(Beck Anxiety Score)(every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points))
- ln(CES-D)(every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points))
研究者
Janice Kiecolt-Glaser
Professor
National Center for Complementary and Integrative Health (NCCIH)