Antioxidants for Vascular Health in Emergency Responders
(VF-EMT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine whether working overnight shifts affects blood vessel health and increases oxidative stress (a harmful condition that damages cells) in emergency medical technicians (EMTs). Researchers seek to understand if antioxidant supplements (an antioxidant cocktail) can reduce these negative effects. Participants will take either antioxidants or a placebo during their night shifts. This trial may suit EMTs who work at least four night shifts a month and have engaged in shift work for over a year. As an unphased trial, it offers EMTs the opportunity to contribute to important research that could enhance health outcomes for shift workers.
Will I have to stop taking my current medications?
If you are taking melatonin or other sleep aids, you will need to stop and have a 72-hour period without them before joining the study. The trial does not specify other medications, so it's best to discuss your current medications with the study team.
Is there any evidence suggesting that the antioxidant cocktail is safe for use in emergency medical technicians?
Research has shown that antioxidants, like those tested in this trial, are generally safe. One study on α-lipoic acid (ALA), an antioxidant in the treatment, found it safe for various groups, including those with diabetes and heart disease. Other studies have examined α-lipoic acid with vitamin C and vitamin E and did not identify major safety issues. These antioxidants can protect cells and tissues from damage caused by oxidative stress. This evidence suggests that the antioxidant mix used in the trial is likely well-tolerated. However, since reactions can vary, discussing any concerns with a healthcare provider is always advisable.12345
Why are researchers excited about this trial?
Most treatments for maintaining vascular health focus on lifestyle changes or medications that target specific risk factors like high blood pressure or cholesterol. But this antioxidant cocktail works differently by directly combating oxidative stress, which is a major contributor to vascular issues. It includes α-lipoic acid, vitamin C, and vitamin E, which together may provide a more comprehensive defense against oxidative damage. Researchers are excited because antioxidants might offer a novel way to support vascular health, especially for emergency responders who face high levels of stress and irregular work hours. If effective, this could introduce a new, easier-to-manage option for maintaining vascular health in high-stress populations.
What evidence suggests that antioxidants might be effective for reducing the negative effects of night shift work in emergency medical technicians?
This trial will compare antioxidant supplementation with a placebo to assess vascular health in emergency responders. Research has shown that antioxidant supplements can improve blood vessel function and reduce oxidative stress, a harmful condition that damages cells. Studies have found that a mix of vitamin C, vitamin E, and α-lipoic acid can decrease harmful free radicals in the body. This combination of antioxidants has also improved blood vessel health, especially after stress from exercise or consuming a salty meal. By reducing oxidative damage, these antioxidants might lessen the negative effects of working night shifts. Overall, evidence suggests that these antioxidants could support vascular health.16789
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take antioxidant or placebo supplements during overnight shifts and report to the lab for vascular function and oxidative stress assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Delaware
Lead Sponsor
Citations
Antioxidant Cocktail Following a High Sodium Meal does not ...
Acute consumption of an antioxidant (AO) cocktail containing vitamin C, E, and alpha-lipoic acid has been shown to lower free radical concentrations in venous ...
Effects of Oral Antioxidant Cocktail in Cardiovascular ...
The purpose of this proposed study is to examine the effects of acute administration of an oral antioxidant cocktail (containing vitamin C, E, and a-lipoic acid ...
Therapeutic perspectives on the combination of α-lipoic ...
This review summarizes recent findings showing that the combination of ALA plus VE has beneficial effects in reducing oxidative damage in ischemic or other ...
Antioxidant supplements and endurance exercise
Antioxidant treatment (e.g., vitamin C, E, α-lipoic acid, and Mito-Q10) has been reported to acutely restore or improve measures of endothelial function, ...
5.
clinicaltrials.gov
clinicaltrials.gov/study/NCT02966665?cond=%22Hypertension%22&intr=%22Tocopherol%22&viewType=Table&rank=5Study Details | : Vascular Function in Health and Disease
Many control mechanisms exist which successfully match the supply of blood with the metabolic demand of various tissues under wide-ranging conditions.
Safety Evaluation of α-Lipoic Acid Supplementation
ALA supplementation was safe, even in subsets of studies categorized according to smoking habit, cardiovascular disease, presence of diabetes, pregnancy status, ...
NCT02966665 | : Vascular Function in Health and Disease
Drug : BH4, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid and L-Ascorbate. Catheter placement in femoral artery and femoral vein; resting measurements of blood ...
Effects of triple antioxidant combination (vitamin E ...
The aim of this study was to assess the protective effects of VE, VC, α-lipoic acid (LA) and their combinations (VELAVC) on the total lipid, cholesterol and ...
A Randomized Factorial Trial of Vitamins C and E and Beta ...
Background Randomized trials have largely failed to support an effect of antioxidant vitamins on the risk of cardiovascular disease (CVD).
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