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

Sponsor

Virginia Commonwealth University (Other)

Overall Status

Completed

CT.gov ID

NCT03216980

Collaborator

(none)

Enrollment

Location

Arms

46.5

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Mental Health Disorders	Dietary Supplement: PTSD/GAD Antioxidant Dietary Supplement: PTSD/GAD Placebo Dietary Supplement: Healthy Control Antioxidant Dietary Supplement: Healthy Control Placebo	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

May 15, 2017

Actual Primary Completion Date :

Mar 31, 2021

Actual Study Completion Date :

Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 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.
Placebo Comparator: PTSD/GAD Placebo Subjects will ingest placebo (microcrystalline cellulose) pills.	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.
Experimental: 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 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.
Placebo Comparator: Healthy Control 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.

Outcome Measures

Primary Outcome Measures

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
Leg Vascular Function (Passive Leg Movement Test) [Before and Immediately After Intervention]
Change in Leg Blood Flow Values from Baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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