Pomegranate Supplementation and Well-Being Among Medical Students and Residents

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Burnout, Professional; Psychological Distress; Antioxidant
• Intervention / Treatment: Dietary supplement: Pomella pomegranate extract; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pomegranate Supplement; Participants in this arm will take a capsule with 500 mg of "Pomella" pomegranate extract twice each day for 28 days.	Dietary supplement: Pomella pomegranate extract; Participants will take a 500 mg capsule of pomegranate extract twice daily for 28 days.
Placebo Comparator: Placebo; Participants in this arm will take a gelatin placebo capsule twice each day for 28 days.	Other: Placebo; Participants will take a gelatin placebo twice daily for 28 days.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Mississippi Medical Center
• Collaborators: University of Rhode Island
• Investigators: Principal Investigator: Joshua Mann, MD, MPH, University of Mississippi Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2017
• Primary Completion (Anticipated): February 1, 2025
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Burnout; Psychological Distress; Pomegranate; Antioxidant
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Occupational Stress; Occupational Diseases; Burnout, Professional; Burnout, Psychological
• Other Study ID Numbers: 2016-0319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No