Pomegranate Supplementation and Well-Being Among Medical Students and Residents

Psychological Distress Clinical Trial

Official title:

Pomegranate Supplementation and Well-Being Among Medical Students and Residents

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03063372
• Other study ID #: 2016-0319
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 28, 2017
• Est. completion date: February 1, 2025

Study information

• Verified date: May 2023
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Antioxidant
• Burnout, Professional
• Burnout, Psychological
• Psychological Distress

Intervention

Dietary Supplement:
• Pomella pomegranate extract
Participants will take a 500 mg capsule of pomegranate extract twice daily for 28 days.

Other:
• Placebo
Participants will take a gelatin placebo twice daily for 28 days.

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
University of Mississippi Medical Center	University of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Scores on Maslach Burnout Inventory over time	Survey instruments	baseline, 4 weeks , 8 weeks
Primary	Changes in health as measured by scores on the RAND Short-Form 12 over time	Survey instrument	baseline, 4 weeks , 8 weeks
Primary	Changes in fatigue as measured by the Iowa Fatigue Scale over time	Survey instrument	baseline, 4 weeks , 8 weeks
Primary	Changes in mental health symptoms measured by the Depression/Anxiety/Stress Scale (21) over time	Survey instrument	baseline, 4 weeks , 8 weeks
Secondary	Change in Serum total antioxidant capacity over time	Serum laboratory test	baseline, 4 weeks, 8 weeks
Secondary	Change in Th1 cytokine levels from peripheral blood and culture supernatants over time	Immunologic tests	baseline, 4 weeks, 8 weeks
Secondary	Change in Th1 cytokine levels from peripheral blood and culture supernatants	Immunologic test	baseline, 4 weeks, 8 weeks
Secondary	Change in Urinary Urolithins over time	Urinary metabolite of pomegranate	baseline, 4 weeks, 8 weeks
Secondary	Change in serum total oxidative stress over time	Serum laboratory test	baseline, 4 weeks, 8 weeks
Secondary	Change in Th2 cytokine levels from peripheral blood and culture supernatants over time	Immunologic test	baseline, 4 weeks, 8 weeks
Secondary	Change in Th17 cytokine levels from peripheral blood and culture supernatants over time	Immunologic test	baseline, 4 weeks, 8 weeks
Secondary	Change in TREG cytokine levels from peripheral blood and culture supernatants over time	Immunologic test	baseline, 4 weeks, 8 weeks