Pomegranate Supplementation and Well-Being Among Medical Students and Residents

Not Applicable

Active, not recruiting

• Conditions: Antioxidant; Burnout, Professional; Psychological Distress
• Interventions: Dietary Supplement: Pomella pomegranate extract; Other: Placebo

• Registration Number: NCT03063372
• Lead Sponsor: University of Mississippi Medical Center

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.

Study Timeline

• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-24
• Study Start: 2017-02-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2027-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pomegranate Supplement	Pomella pomegranate extract	Participants in this arm will take a capsule with 500 mg of "Pomella" pomegranate extract twice each day for 28 days.
Placebo	Placebo	Participants in this arm will take a gelatin placebo capsule twice each day for 28 days.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States