Pomegranate Supplementation and Well-Being Among Medical Students and Residents

NCT03063372 | Active Not Recruiting DMC

• 1 other identifier: 2016-0319
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Antioxidant; Burnout, Professional; Psychological Distress

Keywords

Pomegranate; Burnout; Psychological Distress; Antioxidant

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Change in Serum total antioxidant capacity over time

  baseline, 4 weeks, 8 weeks

• Change in Th1 cytokine levels from peripheral blood and culture supernatants over time

  baseline, 4 weeks, 8 weeks

• Change in Th1 cytokine levels from peripheral blood and culture supernatants

  baseline, 4 weeks, 8 weeks

• Change in Urinary Urolithins over time

  baseline, 4 weeks, 8 weeks

• Change in serum total oxidative stress over time

  baseline, 4 weeks, 8 weeks

Study Arms (2)

Pomegranate Supplement

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Pomella pomegranate extract DIETARY_SUPPLEMENT

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

Pomegranate Supplement

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• First or second year medical student or first or second year resident listed at the University of Mississippi Medical Center

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Mississippi Medical Center: lead
• University of Rhode Island: collaborator

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Burnout, Professional; Burnout, Psychological

Condition Hierarchy (Ancestors)

Occupational Stress; Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Joshua Mann, MD, MPH

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Phase 1 is not masked, but in phase 2 the participants and investigator will be masked (double blind).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: February 24, 2017
• Study Start: February 28, 2017
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)