50 Participants Needed

Pomegranate Supplement for Burnout

Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Mississippi Medical Center

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking any chronic medications and supplements, including over-the-counter multivitamins, to participate in this trial.

Is pomegranate extract safe for human consumption?

Studies show that pomegranate extract is generally safe for humans, with no serious side effects reported in trials involving overweight individuals and healthy volunteers. It also has antioxidant properties and may benefit heart health.12345

How does the pomegranate extract treatment for burnout differ from other treatments?

Pomegranate extract is unique because it is rich in antioxidants, which help reduce oxidative stress, a factor that can contribute to burnout. Unlike other treatments, it is derived from a natural source and has shown potential benefits in improving cardiovascular health and reducing inflammation, which may indirectly support mental well-being.34678

What is the purpose of this trial?

This trial will test if taking pomegranate supplements can help reduce stress and improve well-being in medical students and residents who experience high levels of mental distress and burnout.

Research Team

JM

Joshua Mann, MD, MPH

Principal Investigator

University of Mississippi Medical Center

Eligibility Criteria

This trial is for first or second year medical students and residents at the University of Mississippi Medical Center. It's not suitable for those who are pregnant, planning to become pregnant, breastfeeding, taking chronic medications (other than contraception), using supplements, allergic to pomegranate or gelatin, or have severe depression or anxiety based on DASS-21 scores.

Inclusion Criteria

A first or second year medical student or first or second year resident who is listed at the University of Mississippi Medical Center.

Exclusion Criteria

Pregnant or planning to become pregnant during the study period
Unable to speak, understand, and read English
I am on long-term medications other than birth control.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Treatment

10 participants receive the pomegranate supplement for 28 days

4 weeks
1 visit (in-person) at baseline, 1 visit (in-person) at 4 weeks

Randomized Treatment

40 participants are randomized to receive either the pomegranate supplement or a placebo for 28 days

4 weeks
1 visit (in-person) at baseline, 1 visit (in-person) at 4 weeks

Follow-up

Participants are monitored for changes in mental health symptoms, burnout, fatigue, and various biomarkers

4 weeks
1 visit (in-person) at 8 weeks

Treatment Details

Interventions

  • Placebo
  • Pomella pomegranate extract
Trial Overview The study tests if Pomella pomegranate extract can reduce stress and improve well-being in medical trainees compared to a placebo. Participants will be randomly assigned to receive either the supplement or an inactive substance without knowing which one they're getting.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pomegranate SupplementExperimental Treatment1 Intervention
Participants in this arm will take a capsule with 500 mg of "Pomella" pomegranate extract twice each day for 28 days.
Group II: PlaceboPlacebo Group1 Intervention
Participants in this arm will take a gelatin placebo capsule twice each day for 28 days.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Mississippi Medical Center

Lead Sponsor

Trials
185
Recruited
200,000+

University of Rhode Island

Collaborator

Trials
57
Recruited
22,400+

References

Safety and antioxidant activity of a pomegranate ellagitannin-enriched polyphenol dietary supplement in overweight individuals with increased waist size. [2019]
Pomegranate Extract Improves Maximal Performance of Trained Cyclists after an Exhausting Endurance Trial: A Randomised Controlled Trial. [2020]
Antioxidant Properties and Beneficial Cardiovascular Effects of a Natural Extract of Pomegranate in Healthy Volunteers: A Randomized Preliminary Single-Blind Controlled Study. [2022]
Effects of pomegranate supplementation on exercise performance and post-exercise recovery in healthy adults: a systematic review. [2019]
Effects of pomegranate on lipid profiles: A systematic review of randomised controlled trials. [2020]
An Overview of the Health Benefits, Extraction Methods and Improving the Properties of Pomegranate. [2023]
Beneficial Effects of Pomegranate on Lipid Metabolism in Metabolic Disorders. [2020]
Is Consumption of Pomegranate Supplementation Effective on Oxidative Stress Biomarkers Including MDA, ox-LDL, POX 1, GPX, TAC, and TBRAS? A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2023]
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