Antioxidants for Vascular Health in Emergency Responders

(VF-EMT Trial)

Overseen By Alexs Matias, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Delaware

Must not be taking: Melatonin, Sleep aids

Disqualifiers: Chronic disease, Sleep disorder, others

Compensation: Varies

Number of Visits: 2

Duration: 2 overnight shifts

45 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to characterize blood vessel function and oxidative stress (a harmful condition that damages cells and tissues) in emergency medical technicians (EMTs). The main questions it aims to answer are: 1. Does an overnight shift work in emergency medical technicians reduce blood vessel function and increase oxidative stress? 2. Can supplementing with antioxidants help reduce the negative effects of night shift work in emergency medical technicians? Researchers will compare antioxidants to a placebo (a look-alike substance that contains no drug) to see if antioxidants work in reducing the negative effects of night shift work in emergency medical technicians. Participants will: 1. Report to the lab two separate times following an overnight shift to assess blood vessel functioning and oxidative stress 3. Take an antioxidant supplement or placebo during each night of shift work.

Eligibility Criteria

This trial is for emergency medical technicians who work overnight shifts. It's designed to see if night shift work affects their heart health and stress levels at a cellular level, and whether taking an antioxidant supplement can help.

Inclusion Criteria

Body mass index between 18.5 and <35 kg/m²

Participant must have been working shift work for at least 1 year

Participant must work at least 4 night shifts per month

Exclusion Criteria

I am currently using sleep aids or supplements that could affect my sleep.

Resting blood pressure >140/90 mmHg

Body mass index <18.5 or >35 kg/m2

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take antioxidant or placebo supplements during overnight shifts and report to the lab for vascular function and oxidative stress assessments

2 overnight shifts

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Antioxidant cocktail
• Placebo

Trial Overview The study tests the effects of an antioxidant cocktail compared to a placebo on blood vessel function and oxidative stress in EMTs after night shifts. Participants will visit the lab twice following overnight work to assess these factors.

Participant Groups

Group I: Antioxidant Supplementation Experimental Treatment 1 Intervention

Participants will take two doses of antioxidant supplements in capsule form during their overnight shift: the first dose at 7:00 PM, and the second dose 1.5 hour before their morning vascular function visit (post-shift). Each dose will consist of the following concentrations of antioxidants: 600 mg of α-lipoic acid, 1,000 mg of vitamin C, and 600 IU of vitamin E.

Group II: Placebo Supplementation Placebo Group 1 Intervention

Participants will take two doses of placebo supplements in capsule form during their overnight shift: the first dose at 7:00 PM, and the second dose 1.5 hour before their morning vascular function visit (post-shift). Each dose will consist of placebo pills made from microcrystalline cellulose, designed to match the antioxidants in taste, color, and appearance

Who Is Running the Clinical Trial?

University of Delaware

Lead Sponsor

Trials

167

Recruited

25,700+