search
Back to results

Examining the Effect of Mental Health Disorders on Vascular Function and Exercise Tolerance

Primary Purpose

Mental Health Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PTSD/GAD Antioxidant
PTSD/GAD Placebo
Healthy Control Antioxidant
Healthy Control Placebo
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mental Health Disorders focused on measuring cardiovascular disease, vascular function, PTSD, GAD

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

Exclusion Criteria:

  • taking medications that could influence cardiovascular function
  • limited English proficiency

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

PTSD/GAD Antioxidant

PTSD/GAD Placebo

Healthy Control Antioxidant

Healthy Control Placebo

Arm 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).

Subjects will ingest placebo (microcrystalline cellulose) pills.

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).

Subjects will ingest placebo (microcrystalline cellulose) pills.

Outcomes

Primary Outcome Measures

Arm Vascular Function at Rest (Flow Mediated Dilation Test) and in Response to Exercise (Handgrip Exercise Test)
Change in Brachial Artery Dilation from Baseline Values
Leg Vascular Function (Passive Leg Movement Test)
Change in Leg Blood Flow Values from Baseline

Secondary Outcome Measures

Full Information

First Posted
June 27, 2017
Last Updated
August 24, 2021
Sponsor
Virginia Commonwealth University
search

1. Study Identification

Unique Protocol Identification Number
NCT03216980
Brief Title
Examining the Effect of Mental Health Disorders on Vascular Function and Exercise Tolerance
Official Title
Examining the Effect of Mental Health Disorders on Vascular Function and Exercise Tolerance
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Specific Aim #1: Examining the impact of mental health disorders (PTSD and GAD) on peripheral vascular function and sympathetic nervous system activity in young individuals. Specific Aim #2: Examining the impact of mental health disorders (PTSD and GAD) on peripheral hemodynamics and metabolic byproducts during small muscle mass exercise in young individuals. Specific Aim #3: Examining the impact of mental health disorders (PTSD and GAD) on exercise tolerance, peripheral hemodynamics and metabolic byproducts during large muscle mass exercise in young individuals.
Detailed Description
Mental health disorders are highly prevalent and underdiagnosed and can cause perturbations in cardiovascular and metabolic function leading to substantial individual burden (increased health care cost, loss of work productivity). Post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD), two common mental health disorders, can cause increase cardiovascular disease risk due to chronic increases or fluctuations in heart rate, blood pressure, stress hormones, inflammation, and oxidative stress. Post-traumatic stress disorder (PTSD) is a disabling psychiatric condition characterized by a persistent maladaptive reaction resulting from exposure to severe psychological stress. It has been revealed that individuals with PTSD, in addition to adverse mental health symptoms, also possess higher prevalence rates for physical comorbidities such as hypertension, obesity, diabetes, and metabolic syndrome. Taken together, these PTSD-induced comorbidities result in a significant increase in the likelihood of developing cardiovascular disease (CVD) when compared to individuals without PTSD. Anxiety disorders, the most prevalent mental health issue in the United States, is associated an increased incidence of hypertension and heart disease. This increased cardiovascular disease (CVD) risk is thought to derive from an overactivation of the sympathetic nervous system that results in a predominately pro-oxidant, pro-inflammatory cardiovascular environment. Peripheral vascular dysfunction, or the inability of the blood vessels to adequately respond to specific stimuli, is a factor closely related to CVD. Therefore, this study will focus on a younger population with PTSD or GAD in an attempt to ascertain the presence of peripheral vascular dysfunction and the magnitude to which two potential primary contributors (autonomic dysfunction, oxidative stress) are involved in this dysfunction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Disorders
Keywords
cardiovascular disease, vascular function, PTSD, GAD

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PTSD/GAD Antioxidant
Arm Type
Experimental
Arm 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).
Arm Title
PTSD/GAD Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will ingest placebo (microcrystalline cellulose) pills.
Arm Title
Healthy Control Antioxidant
Arm Type
Experimental
Arm 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).
Arm Title
Healthy Control Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will ingest placebo (microcrystalline cellulose) pills.
Intervention Type
Dietary Supplement
Intervention Name(s)
PTSD/GAD 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)
PTSD/GAD Placebo
Intervention Description
Subjects will ingest placebo (microcrystalline cellulose) pills.
Intervention Type
Dietary Supplement
Intervention Name(s)
Healthy Control 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)
Healthy Control Placebo
Intervention Description
Subjects will ingest placebo (microcrystalline cellulose) pills.
Primary Outcome Measure Information:
Title
Arm Vascular Function at Rest (Flow Mediated Dilation Test) and in Response to Exercise (Handgrip Exercise Test)
Description
Change in Brachial Artery Dilation from Baseline Values
Time Frame
Before and Immediately After Intervention
Title
Leg Vascular Function (Passive Leg Movement Test)
Description
Change in Leg Blood Flow Values from Baseline
Time Frame
Before and Immediately After Intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
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 Exclusion Criteria: taking medications that could influence cardiovascular function limited English proficiency
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

12. IPD Sharing Statement

Learn more about this trial

Examining the Effect of Mental Health Disorders on Vascular Function and Exercise Tolerance

We'll reach out to this number within 24 hrs