What side effects are associated with this type of intervention?

Common treatments for burnout that have antioxidant properties include pomegranate supplementation, ginseng, and guarana. Pomegranate supplementation is generally well-tolerated, but some individuals may experience digestive issues such as diarrhea or stomach cramps. Ginseng can cause side effects like headaches, sleep problems, and gastrointestinal disturbances. Guarana, being a stimulant, may lead to side effects such as increased heart rate, anxiety, and insomnia. It is important to consult with a healthcare provider before starting any new supplement regimen.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved drugs for the treatment of burnout. However, treatments that address related symptoms such as stress and mental distress include various supplements and medications. Antioxidants like pomegranate, which are being studied for their potential to reduce physiological stress, are not yet FDA-approved for burnout but are being explored for their benefits in reducing stress and improving well-being. Other related treatments include melatonin for sleep disturbances and various herbal supplements, though their efficacy and safety are still under investigation.

What other types of research exist?

Promising alternatives to pomegranate supplementation for reducing physiological stress in burnout patients include: 1) Omega-3 fatty acids, which have shown protective effects against stress and inflammation; 2) Regular exercise, which is associated with improved executive functions and reduced stress; 3) Restricted elimination diets, which may help reduce symptoms of hyperactivity and stress; and 4) Green tea catechins, which have minor effects on reducing cardiovascular risk markers and may help with stress management.

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Antioxidant

Pomegranate Supplement for Burnout

N/A

Waitlist Available

Led By Joshua Mann, MD, MPH

Research Sponsored by University of Mississippi Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 weeks, 8 weeks

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Pomegranate extract may cause digestive discomfort or allergic reactions in some individuals. However, since it's a natural antioxidant supplement, serious side effects are less common compared to pharmaceutical drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4 weeks, 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4 weeks, 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks, 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in Scores on Maslach Burnout Inventory over time

Changes in fatigue as measured by the Iowa Fatigue Scale over time

Changes in health as measured by scores on the RAND Short-Form 12 over time

+1 more

Secondary study objectives

Change in Serum total antioxidant capacity over time

Change in TREG cytokine levels from peripheral blood and culture supernatants over time

Change in Th1 cytokine levels from peripheral blood and culture supernatants

+5 more

Trial Design

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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for burnout often focus on reducing oxidative stress and inflammation, which are key contributors to the condition. Antioxidants, like those found in pomegranate, neutralize free radicals and reduce oxidative stress, thereby decreasing inflammation and cellular damage. This mechanism is important for burnout patients as it helps alleviate physiological stress, improving overall well-being and mental health, and addressing the fatigue and mental distress associated with burnout.

Maternal pomegranate juice intake and brain structure and function in infants with intrauterine growth restriction: A randomized controlled pilot study.Melatonin treatment maintains nutraceutical properties of pomegranate fruits during cold storage.Cardioprotective Effects of Pomegranate (Punica granatum) Juice in Patients with Ischemic Heart Disease.