Peripheral Vascular DiseasesNCT04916327
Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 1
A study testing Antioxidant in people with Peripheral Vascular Diseases, run by Virginia Commonwealth University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Vascular Diseases
- What is being tested?
- Antioxidant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 720 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2021to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
- Conditions
- Peripheral Vascular Diseases
- Being tested
- Antioxidant, Placebo
- Keywords
- cardiovascular disease, vascular function, PTSD, GAD, Oxidant
- Medical subject headings
- Peripheral Vascular Diseases, Cardiovascular Diseases, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntioxidantDietary 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).
PlaceboDietary supplement
Subjects will ingest placebo (microcrystalline cellulose) pills.
| Study group | Role | What they receive |
|---|---|---|
| Antioxidant then Placebo | Experimental | Subjects will ingest an antioxidant cocktail prior to their second visit and a placebo prior to third second visit Receives: Dietary Supplement: Antioxidant; Dietary Supplement: Placebo |
| Placebo then Antioxidant | Experimental | Subjects will ingest a placebo prior to their second visit and an antioxidant cocktail prior to their third visit. Receives: Dietary Supplement: Antioxidant; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm Vascular Function at Rest (Flow Mediated Dilation Test)
Change in Brachial Artery Dilation from Baseline Values
Measured: Baseline to the end of the final visit, about 2 weeks
Leg Vascular Function (Passive Leg Movement Test)
Change in Leg Blood Flow Values from Baseline
Measured: Baseline to the end of the final visit, about 2 weeks
Arm Vascular Function in Response to Exercise (Handgrip Exercise Test)
Change in Brachial Artery Dilation from Baseline Values
Measured: Baseline to the end of the final visit, about 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start23 Aug 2021
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Garten, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916327
- Sponsor's protocol ID
- HM20020955-1
- Status last verified
- Sep 2026
- First submitted
- 24 May 2021
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 1
- ClinicalTrials.gov ID
- NCT04916327
- Acronym / sponsor ID
- HM20020955-1
- Conditions
- Peripheral Vascular Diseases
- Keywords
- cardiovascular disease, vascular function, PTSD, GAD, Oxidant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)).
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antioxidant then Placebo | Experimental | Dietary Supplement: Antioxidant, Dietary Supplement: PlaceboSubjects will ingest an antioxidant cocktail prior to their second visit and a placebo prior to third second visit |
| Placebo then Antioxidant | Experimental | Dietary Supplement: Antioxidant, Dietary Supplement: PlaceboSubjects will ingest a placebo prior to their second visit and an antioxidant cocktail prior to their third visit. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntioxidantSubjects 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 supplement | Antioxidant then Placebo, Placebo then Antioxidant |
| PlaceboSubjects will ingest placebo (microcrystalline cellulose) pills. | Dietary supplement | Antioxidant then Placebo, Placebo then Antioxidant |
Primary outcome
Arm Vascular Function at Rest (Flow Mediated Dilation Test)
Time frame: Baseline to the end of the final visit, about 2 weeks
Change in Brachial Artery Dilation from Baseline Values
Leg Vascular Function (Passive Leg Movement Test)
Time frame: Baseline to the end of the final visit, about 2 weeks
Change in Leg Blood Flow Values from Baseline
Arm Vascular Function in Response to Exercise (Handgrip Exercise Test)
Time frame: Baseline to the end of the final visit, about 2 weeks
Change in Brachial Artery Dilation from Baseline Values
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
Related trials for Peripheral Vascular Diseases
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
Peripheral Arterial Disease, Chronic Kidney Diseases
Not yet recruitingPhase 1
Placental Cells for Diabetic Foot Ulcers
Diabetic Foot Ulcer
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ryan Garten, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antioxidant in people with Peripheral Vascular Diseases, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan Garten, PhD ((804) 828-1948, rsgarten@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.