Clinical trial NCT03063372: Pomegranate Supplementation and Well-Being Among Medical Students and Residents
Official title: Pomegranate Supplementation and Well-Being Among Medical Students and Residents
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Antioxidant
Burnout, Professional
Psychological Distress
Keywords: Pomegranate
Burnout
Psychological Distress
Antioxidant
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: University of Rhode Island
First posted: 2017-02-24
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 1 is a single group feasibility pilot in 10 participants, all of whom will receive the nutritional supplement. Phase 2 is a parallel double blinded trial in 40 participants, half of whom will receive the supplement and half of whom will receive a placebo.
Primary purpose: OTHER

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* First or second year medical student or first or second year resident listed at the University of Mississippi Medical Center

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in Scores on Maslach Burnout Inventory over time
timeFrame: baseline, 4 weeks , 8 weeks
measure: Changes in health as measured by scores on the RAND Short-Form 12 over time
timeFrame: baseline, 4 weeks , 8 weeks
measure: Changes in fatigue as measured by the Iowa Fatigue Scale over time
timeFrame: baseline, 4 weeks , 8 weeks
measure: Changes in mental health symptoms measured by the Depression/Anxiety/Stress Scale (21) over time
timeFrame: baseline, 4 weeks , 8 weeks
Secondary outcomes:
measure: Change in Serum total antioxidant capacity over time
timeFrame: baseline, 4 weeks, 8 weeks
measure: Change in Th1 cytokine levels from peripheral blood and culture supernatants over time
timeFrame: baseline, 4 weeks, 8 weeks
measure: Change in Th1 cytokine levels from peripheral blood and culture supernatants
timeFrame: baseline, 4 weeks, 8 weeks
measure: Change in Urinary Urolithins over time
timeFrame: baseline, 4 weeks, 8 weeks
measure: Change in serum total oxidative stress over time
timeFrame: baseline, 4 weeks, 8 weeks
measure: Change in Th2 cytokine levels from peripheral blood and culture supernatants over time
timeFrame: baseline, 4 weeks, 8 weeks
measure: Change in Th17 cytokine levels from peripheral blood and culture supernatants over time
timeFrame: baseline, 4 weeks, 8 weeks
measure: Change in TREG cytokine levels from peripheral blood and culture supernatants over time
timeFrame: baseline, 4 weeks, 8 weeks
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Joshua Mann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: