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Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 1

ConditionPeripheral Vascular Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorVirginia Commonwealth University

About this trial

The purpose of this research study is to examine the role oxidants, substances produced in the blood that can damage blood vessel function, may play in blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and/or generalized anxiety disorder (GAD)).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

apparently healthy and free of overt cardiovascular, pulmonary, or metabolic disease

for PTSD group, a score of ≥ 33 on PCL-5 checklist

for GAD group, a score of ≥ 10 on the GAD-7 self-report scale and < 33 on the PCL-5 checklist

for Healthy Control group, a score of ≤ 10 on the GAD-7 self-report scale and < 33 on the PCL-5 checklist

Disqualifiers

taking medications that could influence cardiovascular function

current smokers who have recently quit smoking

illicit drug use or excessive alcohol consumption

pregnant women

Trial design

Design model

Crossover

Treatments tested in this trial

  • Antioxidant

    Dietary supplement

    Subjects will ingest an antioxidant cocktail containing 800 milligrams of alpha lipoic acid, 1 gram of vitamin C (ascorbic acid), and 400 milligrams of vitamin E (alpha tocopherol).

  • Placebo

    Dietary supplement

    Subjects will ingest placebo (microcrystalline cellulose) pills.

Treatment groups

720 Participants
are divided into 2 treatment groups
Group A: Antioxidant then PlaceboExperimental treatment 2 interventions
Group B: Placebo then AntioxidantExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Arm Vascular Function at Rest (Flow Mediated Dilation Test)

Change in Brachial Artery Dilation from Baseline Values

Time frame
Baseline to the end of the final visit, about 2 weeks
2

Leg Vascular Function (Passive Leg Movement Test)

Change in Leg Blood Flow Values from Baseline

Time frame
Baseline to the end of the final visit, about 2 weeks
3

Arm Vascular Function in Response to Exercise (Handgrip Exercise Test)

Change in Brachial Artery Dilation from Baseline Values

Time frame
Baseline to the end of the final visit, about 2 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Virginia Commonwealth University

Lead sponsor

Source ClinicalTrials.gov
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