NCT04916327

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)).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

August 23, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

4.7 years

First QC Date

May 24, 2021

Last Update Submit

May 4, 2026

Conditions

Peripheral Vascular Diseases

Keywords

cardiovascular diseasevascular functionPTSDGADOxidant

Outcome Measures

Primary Outcomes (3)

  • Arm Vascular Function at Rest (Flow Mediated Dilation Test)

    Change in Brachial Artery Dilation from Baseline Values

    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

    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

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

Study Arms (2)

Antioxidant then Placebo

EXPERIMENTAL

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

Dietary Supplement: AntioxidantDietary 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.

Dietary Supplement: AntioxidantDietary Supplement: Placebo

Interventions

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).

Antioxidant then PlaceboPlacebo then Antioxidant
PlaceboDIETARY_SUPPLEMENT

Subjects will ingest placebo (microcrystalline cellulose) pills.

Antioxidant then PlaceboPlacebo then Antioxidant

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Vascular DiseasesCardiovascular DiseasesStress Disorders, Post-Traumatic

Interventions

Antioxidants

Condition Hierarchy (Ancestors)

Vascular DiseasesStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Biological FactorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesProtective AgentsPhysiological Effects of DrugsSpecialty Uses of Chemicals

Study Officials

  • Ryan Garten, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Garten, PhD

CONTACT

(804) 828-1948rsgarten@vcu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2021

First Posted

June 7, 2021

Study Start

August 23, 2021

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

May 5, 2026

Record last verified: 2026-05

Locations

US(1)