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Active, Not Recruiting

NCT Number: NCT03063372

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

21 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pomella pomegranate extract

Dietary Supplement

Participants will take a 500 mg capsule of pomegranate extract twice daily for 28 days.

Placebo

Other

Participants will take a gelatin placebo twice daily for 28 days.

Primary outcomes

  1. Changes in Scores on Maslach Burnout Inventory over time

    Time frame: baseline, 4 weeks , 8 weeks

    Survey instruments

  2. Changes in health as measured by scores on the RAND Short-Form 12 over time

    Time frame: baseline, 4 weeks , 8 weeks

    Survey instrument

  3. Changes in fatigue as measured by the Iowa Fatigue Scale over time

    Time frame: baseline, 4 weeks , 8 weeks

    Survey instrument

  4. Changes in mental health symptoms measured by the Depression/Anxiety/Stress Scale (21) over time

    Time frame: baseline, 4 weeks , 8 weeks

    Survey instrument

Secondary outcomes

  1. Change in Serum total antioxidant capacity over time

    Time frame: baseline, 4 weeks, 8 weeks

    Serum laboratory test

  2. Change in Th1 cytokine levels from peripheral blood and culture supernatants over time

    Time frame: baseline, 4 weeks, 8 weeks

    Immunologic tests

  3. Change in Th1 cytokine levels from peripheral blood and culture supernatants

    Time frame: baseline, 4 weeks, 8 weeks

    Immunologic test

  4. Change in Urinary Urolithins over time

    Time frame: baseline, 4 weeks, 8 weeks

    Urinary metabolite of pomegranate

  5. Change in serum total oxidative stress over time

    Time frame: baseline, 4 weeks, 8 weeks

    Serum laboratory test

  6. Change in Th2 cytokine levels from peripheral blood and culture supernatants over time

    Time frame: baseline, 4 weeks, 8 weeks

    Immunologic test

  7. Change in Th17 cytokine levels from peripheral blood and culture supernatants over time

    Time frame: baseline, 4 weeks, 8 weeks

    Immunologic test

  8. Change in TREG cytokine levels from peripheral blood and culture supernatants over time

    Time frame: baseline, 4 weeks, 8 weeks

    Immunologic test

Sponsors and collaborators

Lead sponsor

University of Mississippi Medical Center

Other

Collaborators

  • University of Rhode Island

Registry information

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Feb 24, 2017
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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