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Pomegranate Supplementation and Well-Being Among Medical Students and Residents

University of Mississippi logo

University of Mississippi

Status

Active, not recruiting

Conditions

Burnout, Professional
Antioxidant
Psychological Distress

Treatments

Other: Placebo
Dietary Supplement: Pomella pomegranate extract

Study type

Interventional

Funder types

Other

Identifiers

NCT03063372
2016-0319

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

21 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups, including a placebo group

Pomegranate Supplement
Experimental group
Description:
Participants in this arm will take a capsule with 500 mg of "Pomella" pomegranate extract twice each day for 28 days.
Treatment:
Dietary Supplement: Pomella pomegranate extract
Placebo
Placebo Comparator group
Description:
Participants in this arm will take a gelatin placebo capsule twice each day for 28 days.
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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