Pomegranate Supplementation and Well-Being Among Medical Students and Residents

Study Overview
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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.

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.

Official Title
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Pomegranate Supplementation and Well-Being Among Medical Students and Residents

Conditions
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Antioxidant, Burnout, Professional, Psychological Distress

Intervention / Treatment
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* Dietary Supplement: Pomella pomegranate extract
* Other: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pomegranate Supplement<br>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<br>* Participants will take a 500 mg capsule of pomegranate extract twice daily for 28 days.<br>|
| Placebo Comparator: Placebo<br>Participants in this arm will take a gelatin placebo capsule twice each day for 28 days. | Other: Placebo<br>* Participants will take a gelatin placebo twice daily for 28 days.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pomegranate, Burnout, Psychological Distress, Antioxidant