Pomegranate Supplementation and Well-Being Among Medical Students and Residents
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Changes in Scores on Maslach Burnout Inventory over time
研究概览
简要总结
Medical students and residents have high rates of mental distress and burnout related to the intellectual and time demands of their training. Research shows that physiological stress on the body can be a result of fatigue and high stress work, and is associated with experiences related to mental distress. Pomegranate is a fruit that is known to contain a variety of antioxidant substances that can reduce physiological stress. This study will look at the potential for pomegranate supplementation to reduce physiological stress and improve well-being in medical students and residents.
详细描述
This is a pilot study to investigate the feasibility of conducting a randomized trial of pomegranate supplementation in medical students and residents, and to see whether there is evidence of an effect on reported emotional and physical well-being.
Phase 1 will be a pilot with 10 participants in which all will receive the pomegranate supplement for 28 days. In phase 2, we will randomize 40 participants (1:1) to receive either the pomegranate supplement or a placebo.
For both phases, we will measure self reported emotional and physical well-being using several questionnaires, and we will conduct laboratory testing for measures of oxidative stress and inflammatory biomarkers in blood, and for a metabolite of pomegranate in urine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Phase 1 is not masked, but in phase 2 the participants and investigator will be masked (double blind).
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •First or second year medical student or first or second year resident listed at the University of Mississippi Medical Center
排除标准
- •Pregnant or planning to become pregnant during the study period.
- •Breast feeding.
- •Unable to speak, understand, and read English.
- •Taking chronic medications other than contraception
- •Taking supplements (including over-the-counter multivitamins)
- •Allergy to pomegranate or gelatin (gel-caps)
- •Baseline scores on the DASS-21 that indicate a level of depressive or anxiety symptoms that is "severe" or "extremely severe." This would be a depression score greater than 10, or an anxiety score greater than 7.
结局指标
主要结局
Changes in Scores on Maslach Burnout Inventory over time
时间窗: baseline, 4 weeks , 8 weeks
Survey instruments
Changes in fatigue as measured by the Iowa Fatigue Scale over time
时间窗: baseline, 4 weeks , 8 weeks
Survey instrument
Changes in mental health symptoms measured by the Depression/Anxiety/Stress Scale (21) over time
时间窗: baseline, 4 weeks , 8 weeks
Survey instrument
Changes in health as measured by scores on the RAND Short-Form 12 over time
时间窗: baseline, 4 weeks , 8 weeks
Survey instrument
次要结局
- Change in Th1 cytokine levels from peripheral blood and culture supernatants over time(baseline, 4 weeks, 8 weeks)
- Change in TREG cytokine levels from peripheral blood and culture supernatants over time(baseline, 4 weeks, 8 weeks)
- Change in serum total oxidative stress over time(baseline, 4 weeks, 8 weeks)
- Change in Th1 cytokine levels from peripheral blood and culture supernatants(baseline, 4 weeks, 8 weeks)
- Change in Serum total antioxidant capacity over time(baseline, 4 weeks, 8 weeks)
- Change in Urinary Urolithins over time(baseline, 4 weeks, 8 weeks)
- Change in Th2 cytokine levels from peripheral blood and culture supernatants over time(baseline, 4 weeks, 8 weeks)
- Change in Th17 cytokine levels from peripheral blood and culture supernatants over time(baseline, 4 weeks, 8 weeks)
研究者
Joshua Mann
Professor
University of Mississippi Medical Center