Recruiting

Exercise Training

Sponsor:

Virginia Commonwealth University

Code:

NCT04916327

Conditions

Peripheral Vascular Diseases

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Antioxidant

Placebo

Study Details

Brief 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)).

Conditions

Peripheral Vascular Diseases

Study ID

NCT04916327

Start date

Aug 23, 2021

Status verified date

Jun, 2026

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

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:

  • 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

Study Design

Enrollment

720 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Antioxidant then Placebo

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

experimental: Placebo then Antioxidant

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

Interventions

Antioxidant

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

Subjects will ingest placebo (microcrystalline cellulose) pills.

Primary outcome measure

  • Arm Vascular Function at Rest (Flow Mediated Dilation Test) [ Time Frame: Baseline to the end of the final visit, about 2 weeks ]
  • Leg Vascular Function (Passive Leg Movement Test) [ Time Frame: Baseline to the end of the final visit, about 2 weeks ]
  • Arm Vascular Function in Response to Exercise (Handgrip Exercise Test) [ Time Frame: Baseline to the end of the final visit, about 2 weeks ]

Central Contacts and Locations

Central contacts

Ryan Garten, PhD

(804) 828-1948rsgarten@vcu.edu

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-07-01.