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RecruitingNCT04916327Updated Sep 23, 2026

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

An interventional study of Antioxidant and Placebo in Peripheral Vascular Diseases, sponsored by Virginia Commonwealth University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Aug 2021; still recruiting 5 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
720
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study summary

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)).

Read the detailed description

Study #1 is made up of three sessions done on three separate days and the entire study can be completed in as little as two weeks. All testing sessions will take place at the Exercise Physiology Research Laboratory. Volunteers will be asked to participate in one initial testing session (Visit 1) lasting \< 1 hour that will help make them more familiar with the study equipment and procedures, determine body measures (height, weight, body fat), determine the maximum strength of their forearm and calf, and require one blood draw. The following two testing sessions (Visits 2 and 3) with each session lasting between 2-3 hours that will involve multiple tests designed to determine the health of their blood vessels. For Visit #2 they will be randomly given either antioxidant pills or placebo pills to determine the effect of oxidants on blood vessel health. For Visit #3, they will be given whatever set of pills (antioxidant or placebo) that they did not receive during Visit #2.

02

Conditions studied

  • Peripheral Vascular Diseases

Keywords

  • cardiovascular disease
  • vascular function
  • PTSD
  • GAD
  • Oxidant
03

In context

Peripheral Vascular Diseases

443 studies on the registry are indexed under Peripheral Vascular Diseases; 44 are open to participants now.

This study's planned enrollment of 720 is above the median of 80 across 327 interventional studies indexed under Peripheral Vascular Diseases.

Browse Peripheral Vascular Diseases studies →

Lead sponsor

Virginia Commonwealth University is the lead sponsor of 648 studies on the registry; 80 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 64 (71%) have results posted.

Browse Virginia Commonwealth University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • taking medications that could influence cardiovascular function
  • current smokers who have recently quit smoking
  • illicit drug use or excessive alcohol consumption
  • pregnant women
  • significant calorie restriction or vitamin/mineral deficiencies
  • limited English proficiency
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
720 participants (estimated)

Study arms

  • Experimental
    Antioxidant then Placebo

    Subjects will ingest an antioxidant cocktail prior to their second visit and a placebo prior to third second visit

    Dietary Supplement: Antioxidant · Dietary Supplement: Placebo

  • Experimental
    Placebo then Antioxidant

    Subjects will ingest a placebo prior to their second visit and an antioxidant cocktail prior to their third visit.

    Dietary Supplement: Antioxidant · Dietary Supplement: Placebo

Interventions

  • Dietary supplementAntioxidant

    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).

  • Dietary supplementPlacebo

    Subjects will ingest placebo (microcrystalline cellulose) pills.

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2021 (actual). Primary completion is estimated for Aug 2027, 72 months after the start.

Of 48 non-industry interventional studies with no phase under Peripheral Vascular Diseases, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 53. This study's planned 72 months is above that.

Counting every sponsor, half of 68 studies reached it within 29 months; a quarter within 16 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
May 24, 2021
First posted
Jun 7, 2021
StartActual
Aug 23, 2021
Primary completionEst.
Aug 2027
CompletionEst.
Aug 2027
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04916327
Lead sponsor
Virginia Commonwealth University
Responsible party
Sponsor
First posted
Jun 7, 2021
Start date
Aug 23, 2021
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Sep 23, 2026

Study contacts

Ryan Garten, PhD
Contact
rsgarten@vcu.edu
(804) 828-1948
Ryan Garten, PhD
principal investigator · Virginia Commonwealth University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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