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

Not Applicable

Completed

• Conditions: Mental Health Disorders
• Interventions: Dietary Supplement: PTSD/GAD Antioxidant; Dietary Supplement: Healthy Control Antioxidant; Dietary Supplement: PTSD/GAD Placebo; Dietary Supplement: Healthy Control Placebo

• Registration Number: NCT03216980
• Lead Sponsor: Virginia Commonwealth University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-05-15
• Study First Submitted: 2017-06-27
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-13
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTSD/GAD Antioxidant	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).
PTSD/GAD Placebo	PTSD/GAD Antioxidant	Subjects will ingest placebo (microcrystalline cellulose) pills.
Healthy Control Placebo	Healthy Control Antioxidant	Subjects will ingest placebo (microcrystalline cellulose) pills.
PTSD/GAD Placebo	PTSD/GAD Placebo	Subjects will ingest placebo (microcrystalline cellulose) pills.
Healthy Control Antioxidant	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).
PTSD/GAD Antioxidant	PTSD/GAD Placebo	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 Antioxidant	Healthy Control Placebo	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	Healthy Control Placebo	Subjects will ingest placebo (microcrystalline cellulose) pills.

Primary Outcome Measures

Name	Time	Method
Leg Vascular Function (Passive Leg Movement Test)	Before and Immediately After Intervention	Change in Leg Blood Flow Values from Baseline
Arm Vascular Function at Rest (Flow Mediated Dilation Test) and in Response to Exercise (Handgrip Exercise Test)	Before and Immediately After Intervention	Change in Brachial Artery Dilation from Baseline Values

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States