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

NCT ID: NCT03216980

Last Updated: 2021-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-15

Study Completion Date

2021-03-31

Brief Summary

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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

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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.

Conditions

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Mental Health Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PTSD/GAD 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).

Group Type EXPERIMENTAL

PTSD/GAD Antioxidant

Intervention Type DIETARY_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).

PTSD/GAD Placebo

Intervention Type DIETARY_SUPPLEMENT

Subjects will ingest placebo (microcrystalline cellulose) pills.

PTSD/GAD Placebo

Subjects will ingest placebo (microcrystalline cellulose) pills.

Group Type PLACEBO_COMPARATOR

PTSD/GAD Antioxidant

Intervention Type DIETARY_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).

PTSD/GAD Placebo

Intervention Type DIETARY_SUPPLEMENT

Subjects will ingest placebo (microcrystalline cellulose) pills.

Healthy Control 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).

Group Type EXPERIMENTAL

Healthy Control Antioxidant

Intervention Type DIETARY_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).

Healthy Control Placebo

Intervention Type DIETARY_SUPPLEMENT

Subjects will ingest placebo (microcrystalline cellulose) pills.

Healthy Control Placebo

Subjects will ingest placebo (microcrystalline cellulose) pills.

Group Type PLACEBO_COMPARATOR

Healthy Control Antioxidant

Intervention Type DIETARY_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).

Healthy Control Placebo

Intervention Type DIETARY_SUPPLEMENT

Subjects will ingest placebo (microcrystalline cellulose) pills.

Interventions

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PTSD/GAD 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).

Intervention Type DIETARY_SUPPLEMENT

PTSD/GAD Placebo

Subjects will ingest placebo (microcrystalline cellulose) pills.

Intervention Type DIETARY_SUPPLEMENT

Healthy Control 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).

Intervention Type DIETARY_SUPPLEMENT

Healthy Control Placebo

Subjects will ingest placebo (microcrystalline cellulose) pills.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ryan Garten, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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HM20009929

Identifier Type: -

Identifier Source: org_study_id

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