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

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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

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 for a Trial Participant

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

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?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7396284/

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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03629613

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 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0271531705002812

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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7284926/

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=5

Study 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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7603186/

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, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02966665

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 ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1065699505001149

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 ...

9. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/769855

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).