Vascular Function and Oxidative Stress in Emergency Medical Responders

NCT ID: NCT06985394

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-14
• Study Completion Date: 2025-10-31

Brief Summary

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.

Detailed Description

Heart disease, also referred to as cardiovascular disease, is the leading cause of death worldwide, responsible for about 30% of all deaths. While eating right, staying active, and avoiding cigarettes are key to preventing heart problems, the type of work a person does matters too. Some jobs can negatively affect heart health, especially those with night or irregular shifts. Emergency medical technicians (EMTs), the first responders who help keep our communities safe, often work these challenging schedules.

Shift work means working outside normal business hours-like evenings, nights, and weekends. These irregular schedules, especially overnight shifts, can disrupt the body's natural sleep cycle. This disruption can cause health problems because it goes against the body's internal clock, or circadian rhythm. This rhythm controls important functions like sleep, hormone levels, and heart health. When someone works at night, this clock is disrupted, which can lead to higher stress levels, worse blood vessel function, and even long-term damage to the heart. Research shows that people who work night shifts have a higher risk of heart disease compared to those who work during the day. The risk increases even more the longer someone works night shifts. In fact, studies show that each additional five years of night shift work raises the risk of heart problems by 7%. One night of shift work is all it takes to cause damage to blood vessels and spike stress levels in the body.

This study will examine how night shift work affects emergency medical technicians' heart and blood vessel health. The investigators will compare the function of their blood vessels and levels of oxidative stress (a harmful condition that damages cells and tissues) after working two overnight shifts. To understand how to best help reduce the negative effects of night shift work, this study will also test whether taking antioxidants-substances that protect the body from damage induced by oxidative stress-during one of the shifts can improve blood vessel health and reduce oxidative stress. Emergency medical technicians are a group that have not been researched much in this area and by doing so, this study hopes to learn more about how night shift work affects heart and blood vessel health. If antioxidants can help, this could lead to new ways of protecting shift workers from long-term heart problems-especially emergency medical technicians and first responders, who are vital to our community's safety.

Conditions

Cardiovascular Function in EMTs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Antioxidant Supplementation

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 Type: EXPERIMENTAL

Antioxidant cocktail

Intervention Type: DIETARY_SUPPLEMENT

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.

Placebo Supplementation

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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 placebo pills made from microcrystalline cellulose, designed to match the antioxidants in taste, color, and appearance.

Interventions

Antioxidant cocktail

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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 placebo pills made from microcrystalline cellulose, designed to match the antioxidants in taste, color, and appearance.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Body mass index between 18.5 and <35 kg/m²
• Seated resting systolic blood pressure < 140 mmHg, and seated resting diastolic blood pressure < 90 mmHg
• Participant must be an active first responder that works shift work schedules. e.g., emergency medical responders, basic life support emergency medical technicians (i.e., BLS EMT), advanced life support emergency medical technicians (A-EMT), and paramedics
• Participant must have been working shift work for at least 1 year
• Participant must work at least 4 night shifts per month

Exclusion Criteria

• Participant is unwilling or unable to give consent
• Participant has been diagnosed with any chronic disease (a history of high blood pressure, heart disease, diabetes, cancer, kidney disease)
• Participant has been diagnosed with a sleep disorder (e.g., insomnia, restless leg syndrome, sleep apnea)
• Participant is currently taking melatonin or other sleep aids (e.g., Ambien, sedatives, etc.), or any supplements/medications known to alter sleep patterns. Participants using melatonin must undergo a minimum 72-hour washout period prior to study participation to ensure baseline sleep patterns are not affected[15, 16]
• Resting blood pressure >140/90 mmHg
• Body mass index <18.5 or >35 kg/m2
• Currently pregnant or breast feeding (women only)
• Currently use tobacco or nicotine products (≥1 cigarette, cigar, e-cigarette, vape, or any other nicotine-containing product in the last month), including smokeless tobacco (e.g., chewing tobacco, snuff, dip, snus), nicotine lozenges or gum, heated tobacco products, and any illicit drugs

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Delaware

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Delaware

Newark, Delaware, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alexs Matias, MS

Role: CONTACT

amatias@udel.edu

914-523-1953

Facility Contacts

Alexs Matias, MS

Role: primary

amatias@udel.edu

914-523-1953

Other Identifiers

2291409-1

Identifier Type: -

Identifier Source: org_study_id