Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Rhode Island | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pomegranate Supplement | Experimental | Participants in this arm will take a capsule with 500 mg of "Pomella" pomegranate extract twice each day for 28 days. |
|
| Placebo | Placebo Comparator | Participants in this arm will take a gelatin placebo capsule twice each day for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pomella pomegranate extract | Dietary Supplement | Participants will take a 500 mg capsule of pomegranate extract twice daily for 28 days. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joshua Mann, MD, MPH | University of Mississippi Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
We do not plan to share IPD.
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 19, 2025 | |
| Reset | Jan 12, 2026 | |
| Release | Mar 27, 2026 | |
| Reset | Apr 16, 2026 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 19, 2025 | Jan 12, 2026 | |||
| Mar 27, 2026 |
| ID | Term |
|---|---|
| D002055 | Burnout, Professional |
| D000077062 | Burnout, Psychological |
| ID | Term |
|---|---|
| D000073397 | Occupational Stress |
| D009784 | Occupational Diseases |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
Not provided
Not provided
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.
Not provided
Not provided
Phase 1 is not masked, but in phase 2 the participants and investigator will be masked (double blind).
| Placebo | Other | Participants will take a gelatin placebo twice daily for 28 days. |
|
| 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 |
| Apr 16, 2026 |
| D001519 |
| Behavior |