Pomegranate Supplementation and Well-Being Among Medical Students and Residents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-28

Study Completion Date

2027-02-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Antioxidant Burnout, Professional Psychological Distress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Phase 1 is not masked, but in phase 2 the participants and investigator will be masked (double blind).

Study Groups

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Pomegranate Supplement

Participants in this arm will take a capsule with 500 mg of "Pomella" pomegranate extract twice each day for 28 days.

Group Type EXPERIMENTAL

Pomella pomegranate extract

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Participants in this arm will take a gelatin placebo capsule twice each day for 28 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Pomella pomegranate extract

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes