Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 1

Virginia Commonwealth University (VCU)

Status: Enrolling

Conditions: Peripheral Vascular Diseases

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Antioxidant

Study type: Interventional

Funder types: Other

Identifiers

NCT04916327

HM20020955-1

Details and patient eligibility

About

The purpose of this research study is to examine the role oxidants, substances produced in the blood that can damage blood vessel function, may play in blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and/or generalized anxiety disorder (GAD)).

Full description

Study #1 is made up of three sessions done on three separate days and the entire study can be completed in as little as two weeks. All testing sessions will take place at the Exercise Physiology Research Laboratory. Volunteers will be asked to participate in one initial testing session (Visit 1) lasting < 1 hour that will help make them more familiar with the study equipment and procedures, determine body measures (height, weight, body fat), determine the maximum strength of their forearm and calf, and require one blood draw. The following two testing sessions (Visits 2 and 3) with each session lasting between 2-3 hours that will involve multiple tests designed to determine the health of their blood vessels. For Visit #2 they will be randomly given either antioxidant pills or placebo pills to determine the effect of oxidants on blood vessel health. For Visit #3, they will be given whatever set of pills (antioxidant or placebo) that they did not receive during Visit #2.

Enrollment: 720 estimated 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 and < 33 on the PCL-5 checklist
• for Healthy Control group, a score of ≤ 10 on the GAD-7 self-report scale and < 33 on the PCL-5 checklist

Exclusion criteria

• taking medications that could influence cardiovascular function
• current smokers who have recently quit smoking
• illicit drug use or excessive alcohol consumption
• pregnant women
• significant calorie restriction or vitamin/mineral deficiencies
• limited English proficiency

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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720 participants in 2 patient groups

Antioxidant then Placebo

Experimental group

Description:

Subjects will ingest an antioxidant cocktail prior to their second visit and a placebo prior to third second visit

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Antioxidant

Placebo then Antioxidant

Experimental group

Description:

Subjects will ingest a placebo prior to their second visit and an antioxidant cocktail prior to their third visit.

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Antioxidant