Pomegranate Supplementation and Well-Being Among Medical Students and Residents

Sponsor

University of Mississippi Medical Center (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03063372

Collaborator

University of Rhode Island (Other)

Enrollment

Location

Arms

71.1

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Antioxidant Burnout, Professional Psychological Distress	Dietary Supplement: Pomella pomegranate extract Other: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Double (Participant, Investigator)

Masking Description:

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

Primary Purpose:

Other

Official Title:

Pomegranate Supplementation and Well-Being Among Medical Students and Residents

Actual Study Start Date :

Feb 28, 2017

Anticipated Primary Completion Date :

Feb 1, 2022

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Changes in Scores on Maslach Burnout Inventory over time [baseline, 4 weeks , 8 weeks]
Survey instruments
Changes in health as measured by scores on the RAND Short-Form 12 over time [baseline, 4 weeks , 8 weeks]
Survey instrument
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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.