Pomegranate Supplement for Burnout

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Mississippi Medical Center

Must not be taking: Chronic medications, Supplements

Disqualifiers: Pregnancy, Breastfeeding, Severe depression, others

Compensation: Varies

Number of Visits: 3

50 Participants Needed

What You Need to Know Before You Apply

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.

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. ^{1 2 3 4 5}

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. ^{3 4 6 7 8}

Who Is on the Research Team?

Joshua Mann, MD, MPH

Principal Investigator

University of Mississippi Medical Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Pomegranate Supplement Experimental Treatment 1 Intervention

Participants in this arm will take a capsule with 500 mg of "Pomella" pomegranate extract twice each day for 28 days.

Group II: Placebo Placebo Group 1 Intervention

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

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+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Safety and antioxidant activity of a pomegranate ellagitannin-enriched polyphenol dietary supplement in overweight individuals with increased waist size. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Pomegranate Extract Improves Maximal Performance of Trained Cyclists after an Exhausting Endurance Trial: A Randomised Controlled Trial. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Antioxidant Properties and Beneficial Cardiovascular Effects of a Natural Extract of Pomegranate in Healthy Volunteers: A Randomized Preliminary Single-Blind Controlled Study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effects of pomegranate supplementation on exercise performance and post-exercise recovery in healthy adults: a systematic review. [2019]

5. Scotland pubmed.ncbi.nlm.nih.gov

Effects of pomegranate on lipid profiles: A systematic review of randomised controlled trials. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

An Overview of the Health Benefits, Extraction Methods and Improving the Properties of Pomegranate. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Beneficial Effects of Pomegranate on Lipid Metabolism in Metabolic Disorders. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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]