Clinical Trial: Pomegranate Supplementation and Well-Being Among Medical Students and Residents

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Pomegranate Supplementation and Well-Being Among Medical Students and Residents

Brief Summary: 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.

Detailed Summary:

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.

Sponsor: University of Mississippi Medical Center

Current Primary Outcome:

• Changes in Scores on Maslach Burnout Inventory over time [ Time Frame: baseline, 4 weeks , 8 weeks ]
  Survey instruments
• Changes in health as measured by scores on the RAND Short-Form 12 over time [ Time Frame: baseline, 4 weeks , 8 weeks ]
  Survey instrument
• Changes in fatigue as measured by the Iowa Fatigue Scale over time [ Time Frame: baseline, 4 weeks , 8 weeks ]
  Survey instrument
• Changes in mental health symptoms measured by the Depression/Anxiety/Stress Scale (21) over time [ Time Frame: baseline, 4 weeks , 8 weeks ]
  Survey instrument

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in Serum total antioxidant capacity over time [ Time Frame: baseline, 4 weeks, 8 weeks ]
  Serum laboratory test
• Change in Th1 cytokine levels from peripheral blood and culture supernatants over time [ Time Frame: baseline, 4 weeks, 8 weeks ]
  Immunologic tests
• Change in Th1 cytokine levels from peripheral blood and culture supernatants [ Time Frame: baseline, 4 weeks, 8 weeks ]
  Immunologic test
• Change in Urinary Urolithins over time [ Time Frame: baseline, 4 weeks, 8 weeks ]
  Urinary metabolite of pomegranate
• Change in serum total oxidative stress over time [ Time Frame: baseline, 4 weeks, 8 weeks ]
  Serum laboratory test
• Change in Th2 cytokine levels from peripheral blood and culture supernatants over time [ Time Frame: baseline, 4 weeks, 8 weeks ]
  Immunologic test
• Change in Th17 cytokine levels from peripheral blood and culture supernatants over time [ Time Frame: baseline, 4 weeks, 8 weeks ]
  Immunologic test
• Change in TREG cytokine levels from peripheral blood and culture supernatants over time [ Time Frame: baseline, 4 weeks, 8 weeks ]
  Immunologic test

Original Secondary Outcome: Same as current

Information By: University of Mississippi Medical Center

Dates:
Date Received: February 16, 2017
Date Started: February 28, 2017
Date Completion: February 1, 2018
Last Updated: May 1, 2017
Last Verified: May 2017