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

Primary Purpose

Peripheral Vascular Diseases

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Antioxidant

Placebo

About this trial

This is an interventional basic science trial for Peripheral Vascular Diseases focused on measuring cardiovascular disease, vascular function, PTSD, GAD, Oxidant

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Virginia Commonwealth UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Antioxidant then Placebo

Placebo then Antioxidant

Arm Description

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

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

Outcomes

Primary Outcome Measures

Arm Vascular Function at Rest (Flow Mediated Dilation Test)

Change in Brachial Artery Dilation from Baseline Values

Leg Vascular Function (Passive Leg Movement Test)

Change in Leg Blood Flow Values from Baseline

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

Change in Brachial Artery Dilation from Baseline Values

Secondary Outcome Measures

Full Information

NCT ID

NCT04916327

First Posted

May 24, 2021

Last Updated

August 3, 2023

Sponsor

Virginia Commonwealth University

1. Study Identification

Unique Protocol Identification Number

NCT04916327

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 23, 2021 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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)).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Vascular Diseases

Keywords

cardiovascular disease, vascular function, PTSD, GAD, Oxidant

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

720 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Antioxidant then Placebo

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo then Antioxidant

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Antioxidant

Intervention Description

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).

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Subjects will ingest placebo (microcrystalline cellulose) pills.

Primary Outcome Measure Information:

Title

Arm Vascular Function at Rest (Flow Mediated Dilation Test)

Description

Change in Brachial Artery Dilation from Baseline Values

Time Frame

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

Title

Leg Vascular Function (Passive Leg Movement Test)

Description

Change in Leg Blood Flow Values from Baseline

Time Frame

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

Title

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

Description

Change in Brachial Artery Dilation from Baseline Values

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ryan Garten, PhD

Phone

(804) 828-1948

rsgarten@vcu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ryan Garten, PhD

Organizational Affiliation

Virginia Commonwealth University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Virginia Commonwealth University

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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