AntioxidantNCT03063372
Pomegranate Supplementation and Well-Being Among Medical Students and Residents
A study testing Pomella pomegranate extract in people with Antioxidant and Burnout, Professional, run by University of Mississippi Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Antioxidant, Burnout, Professional, Psychological Distress
- What is being tested?
- Pomella pomegranate extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2017to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- First or second year medical student or first or second year resident listed at the University of Mississippi Medical Center
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
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.
Read the 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.
- Conditions
- Antioxidant, Burnout, Professional, Psychological Distress
- Being tested
- Pomella pomegranate extract, Placebo
- Keywords
- Pomegranate, Burnout, Psychological Distress, Antioxidant
- Medical subject headings
- Burnout, Professional, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomella pomegranate extractDietary supplement
Participants will take a 500 mg capsule of pomegranate extract twice daily for 28 days.
PlaceboOther
Participants will take a gelatin placebo twice daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Pomegranate Supplement | Experimental | Participants in this arm will take a capsule with 500 mg of "Pomella" pomegranate extract twice each day for 28 days. Receives: Dietary Supplement: Pomella pomegranate extract |
| Placebo | Placebo comparator | Participants in this arm will take a gelatin placebo capsule twice each day for 28 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Scores on Maslach Burnout Inventory over time
Survey instruments
Measured: baseline, 4 weeks , 8 weeks
Changes in health as measured by scores on the RAND Short-Form 12 over time
Survey instrument
Measured: baseline, 4 weeks , 8 weeks
Changes in fatigue as measured by the Iowa Fatigue Scale over time
Survey instrument
Measured: baseline, 4 weeks , 8 weeks
Changes in mental health symptoms measured by the Depression/Anxiety/Stress Scale (21) over time
Survey instrument
Measured: baseline, 4 weeks , 8 weeks
Secondary outcomes (8)
Change in Serum total antioxidant capacity over time
Serum laboratory test
Measured: baseline, 4 weeks, 8 weeks
Change in Th1 cytokine levels from peripheral blood and culture supernatants over time
Immunologic tests
Measured: baseline, 4 weeks, 8 weeks
Change in Th1 cytokine levels from peripheral blood and culture supernatants
Immunologic test
Measured: baseline, 4 weeks, 8 weeks
Change in Urinary Urolithins over time
Urinary metabolite of pomegranate
Measured: baseline, 4 weeks, 8 weeks
Change in serum total oxidative stress over time
Serum laboratory test
Measured: baseline, 4 weeks, 8 weeks
Change in Th2 cytokine levels from peripheral blood and culture supernatants over time
Immunologic test
Measured: baseline, 4 weeks, 8 weeks
Change in Th17 cytokine levels from peripheral blood and culture supernatants over time
Immunologic test
Measured: baseline, 4 weeks, 8 weeks
Change in TREG cytokine levels from peripheral blood and culture supernatants over time
Immunologic test
Measured: baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start28 Feb 2017
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AntioxidantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rhode Island
- Responsible party
- Principal investigator, Joshua Mann, University of Mississippi Medical Center
- Investigators
- Joshua Mann, MD, MPH, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063372
- Sponsor's protocol ID
- 2016-0319
- Status last verified
- Mar 2025
- First submitted
- 16 Feb 2017
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pomegranate Supplementation and Well-Being Among Medical Students and Residents
- ClinicalTrials.gov ID
- NCT03063372
- Acronym / sponsor ID
- 2016-0319
- Conditions
- Antioxidant, Burnout, Professional, Psychological Distress
- Keywords
- Pomegranate, Burnout, Psychological Distress, Antioxidant
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- University of Rhode Island
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 24 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pomegranate Supplement | Experimental | Dietary Supplement: Pomella pomegranate extractParticipants in this arm will take a capsule with 500 mg of "Pomella" pomegranate extract twice each day for 28 days. |
| Placebo | Placebo comparator | Other: PlaceboParticipants in this arm will take a gelatin placebo capsule twice each day for 28 days. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- First or second year medical student or first or second year resident listed at the University of Mississippi Medical Center
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pomella pomegranate extractParticipants will take a 500 mg capsule of pomegranate extract twice daily for 28 days. | Dietary supplement | Pomegranate Supplement |
| PlaceboParticipants will take a gelatin placebo twice daily for 28 days. | Other | Placebo |
Primary outcome
Changes in Scores on Maslach Burnout Inventory over time
Time frame: baseline, 4 weeks , 8 weeks
Survey instruments
Changes in health as measured by scores on the RAND Short-Form 12 over time
Time frame: baseline, 4 weeks , 8 weeks
Survey instrument
Changes in fatigue as measured by the Iowa Fatigue Scale over time
Time frame: baseline, 4 weeks , 8 weeks
Survey instrument
Changes in mental health symptoms measured by the Depression/Anxiety/Stress Scale (21) over time
Time frame: baseline, 4 weeks , 8 weeks
Survey instrument
8 secondary outcomes
Change in Serum total antioxidant capacity over time
Time frame: baseline, 4 weeks, 8 weeks
Change in Th1 cytokine levels from peripheral blood and culture supernatants over time
Time frame: baseline, 4 weeks, 8 weeks
Change in Th1 cytokine levels from peripheral blood and culture supernatants
Time frame: baseline, 4 weeks, 8 weeks
Change in Urinary Urolithins over time
Time frame: baseline, 4 weeks, 8 weeks
Change in serum total oxidative stress over time
Time frame: baseline, 4 weeks, 8 weeks
Change in Th2 cytokine levels from peripheral blood and culture supernatants over time
Time frame: baseline, 4 weeks, 8 weeks
Change in Th17 cytokine levels from peripheral blood and culture supernatants over time
Time frame: baseline, 4 weeks, 8 weeks
Change in TREG cytokine levels from peripheral blood and culture supernatants over time
Time frame: baseline, 4 weeks, 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No. We do not plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Mann, MD, MPH principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pomella pomegranate extract in people with Antioxidant and Burnout, Professional, run by University of Mississippi Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Scores on Maslach Burnout Inventory over time (time frame: baseline, 4 weeks , 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.