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

Virginia Commonwealth University (VCU) logo

Virginia Commonwealth University (VCU)

Status

Completed

Conditions

Mental Health Disorders

Treatments

Dietary Supplement: PTSD/GAD Placebo
Dietary Supplement: Healthy Control Placebo
Dietary Supplement: PTSD/GAD Antioxidant
Dietary Supplement: Healthy Control Antioxidant

Study type

Interventional

Funder types

Other

Identifiers

NCT03216980
HM20009929

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 4 patient groups, including a placebo group

PTSD/GAD Antioxidant
Experimental group
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).
Treatment:
Dietary Supplement: PTSD/GAD Placebo
Dietary Supplement: PTSD/GAD Antioxidant
PTSD/GAD Placebo
Placebo Comparator group
Description:
Subjects will ingest placebo (microcrystalline cellulose) pills.
Treatment:
Dietary Supplement: PTSD/GAD Placebo
Dietary Supplement: PTSD/GAD Antioxidant
Healthy Control Antioxidant
Experimental group
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).
Treatment:
Dietary Supplement: Healthy Control Placebo
Dietary Supplement: Healthy Control Antioxidant
Healthy Control Placebo
Placebo Comparator group
Description:
Subjects will ingest placebo (microcrystalline cellulose) pills.
Treatment:
Dietary Supplement: Healthy Control Placebo
Dietary Supplement: Healthy Control Antioxidant

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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