What this study is
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.
What's being tested
- Antioxidant cocktail
Intervention · 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
Intervention · 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.
Study details
- Sponsor
- University of Delaware
- Conditions
- Cardiovascular Function in EMTs
- Enrolling
- 45 people
- Starts
- 2025-05-14
- Est. completion
- 2025-10
- Design
- Single-blind, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 20 Years – 40 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Delaware
Newark, Delaware, United States
- Alexs Matias, MS · Contact914-523-1953amatias@udel.edu
Recruiting
Study team
Sponsor
University of Delaware
Study ID 2291409-1
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.