Trials / Completed
CompletedNCT03216980
Examining the Effect of Mental Health Disorders on Vascular Function and Exercise Tolerance
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Virginia Commonwealth University · Academic / Other
- Sex
- All
- Age
- 18 Years – 35 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | 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). |
| DIETARY_SUPPLEMENT | PTSD/GAD Placebo | Subjects will ingest placebo (microcrystalline cellulose) pills. |
| 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). |
| DIETARY_SUPPLEMENT | Healthy Control Placebo | Subjects will ingest placebo (microcrystalline cellulose) pills. |
Timeline
- Start date
- 2017-05-15
- Primary completion
- 2021-03-31
- Completion
- 2021-03-31
- First posted
- 2017-07-13
- Last updated
- 2021-08-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03216980. Inclusion in this directory is not an endorsement.