Pomegranate Supplementation and Well-Being Among Medical Students and Residents
Primary Purpose
Antioxidant, Burnout, Professional, Psychological Distress
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pomella pomegranate extract
Placebo
Sponsored by
About this trial
This is an interventional other trial for Antioxidant focused on measuring Pomegranate, Burnout, Psychological Distress, Antioxidant
Eligibility Criteria
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.
Sites / Locations
- University of Mississippi Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Pomegranate Supplement
Placebo
Arm Description
Participants in this arm will take a capsule with 500 mg of "Pomella" pomegranate extract twice each day for 28 days.
Participants in this arm will take a gelatin placebo capsule twice each day for 28 days.
Outcomes
Primary Outcome Measures
Changes in Scores on Maslach Burnout Inventory over time
Survey instruments
Changes in health as measured by scores on the RAND Short-Form 12 over time
Survey instrument
Changes in fatigue as measured by the Iowa Fatigue Scale over time
Survey instrument
Changes in mental health symptoms measured by the Depression/Anxiety/Stress Scale (21) over time
Survey instrument
Secondary Outcome Measures
Change in Serum total antioxidant capacity over time
Serum laboratory test
Change in Th1 cytokine levels from peripheral blood and culture supernatants over time
Immunologic tests
Change in Th1 cytokine levels from peripheral blood and culture supernatants
Immunologic test
Change in Urinary Urolithins over time
Urinary metabolite of pomegranate
Change in serum total oxidative stress over time
Serum laboratory test
Change in Th2 cytokine levels from peripheral blood and culture supernatants over time
Immunologic test
Change in Th17 cytokine levels from peripheral blood and culture supernatants over time
Immunologic test
Change in TREG cytokine levels from peripheral blood and culture supernatants over time
Immunologic test
Full Information
NCT ID
NCT03063372
First Posted
February 16, 2017
Last Updated
May 11, 2023
Sponsor
University of Mississippi Medical Center
Collaborators
University of Rhode Island
1. Study Identification
Unique Protocol Identification Number
NCT03063372
Brief Title
Pomegranate Supplementation and Well-Being Among Medical Students and Residents
Official Title
Pomegranate Supplementation and Well-Being Among Medical Students and Residents
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 28, 2017 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mississippi Medical Center
Collaborators
University of Rhode Island
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antioxidant, Burnout, Professional, Psychological Distress
Keywords
Pomegranate, Burnout, Psychological Distress, Antioxidant
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
Phase 1 is not masked, but in phase 2 the participants and investigator will be masked (double blind).
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pomegranate Supplement
Arm Type
Experimental
Arm Description
Participants in this arm will take a capsule with 500 mg of "Pomella" pomegranate extract twice each day for 28 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will take a gelatin placebo capsule twice each day for 28 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Pomella pomegranate extract
Intervention Description
Participants will take a 500 mg capsule of pomegranate extract twice daily for 28 days.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants will take a gelatin placebo twice daily for 28 days.
Primary Outcome Measure Information:
Title
Changes in Scores on Maslach Burnout Inventory over time
Description
Survey instruments
Time Frame
baseline, 4 weeks , 8 weeks
Title
Changes in health as measured by scores on the RAND Short-Form 12 over time
Description
Survey instrument
Time Frame
baseline, 4 weeks , 8 weeks
Title
Changes in fatigue as measured by the Iowa Fatigue Scale over time
Description
Survey instrument
Time Frame
baseline, 4 weeks , 8 weeks
Title
Changes in mental health symptoms measured by the Depression/Anxiety/Stress Scale (21) over time
Description
Survey instrument
Time Frame
baseline, 4 weeks , 8 weeks
Secondary Outcome Measure Information:
Title
Change in Serum total antioxidant capacity over time
Description
Serum laboratory test
Time Frame
baseline, 4 weeks, 8 weeks
Title
Change in Th1 cytokine levels from peripheral blood and culture supernatants over time
Description
Immunologic tests
Time Frame
baseline, 4 weeks, 8 weeks
Title
Change in Th1 cytokine levels from peripheral blood and culture supernatants
Description
Immunologic test
Time Frame
baseline, 4 weeks, 8 weeks
Title
Change in Urinary Urolithins over time
Description
Urinary metabolite of pomegranate
Time Frame
baseline, 4 weeks, 8 weeks
Title
Change in serum total oxidative stress over time
Description
Serum laboratory test
Time Frame
baseline, 4 weeks, 8 weeks
Title
Change in Th2 cytokine levels from peripheral blood and culture supernatants over time
Description
Immunologic test
Time Frame
baseline, 4 weeks, 8 weeks
Title
Change in Th17 cytokine levels from peripheral blood and culture supernatants over time
Description
Immunologic test
Time Frame
baseline, 4 weeks, 8 weeks
Title
Change in TREG cytokine levels from peripheral blood and culture supernatants over time
Description
Immunologic test
Time Frame
baseline, 4 weeks, 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Mann, MD, MPH
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to share IPD.
Learn more about this trial
Pomegranate Supplementation and Well-Being Among Medical Students and Residents
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