Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 1
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 720
- Locations
- 1
- Primary Endpoint
- Arm Vascular Function at Rest (Flow Mediated Dilation Test)
Study Overview
Brief Summary
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)).
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- 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 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
Arms & Interventions
Placebo then Antioxidant
Subjects will ingest a placebo prior to their second visit and an antioxidant cocktail prior to their third visit.
Intervention: Placebo (Dietary Supplement)
Antioxidant then Placebo
Subjects will ingest an antioxidant cocktail prior to their second visit and a placebo prior to third second visit
Intervention: Placebo (Dietary Supplement)
Antioxidant then Placebo
Subjects will ingest an antioxidant cocktail prior to their second visit and a placebo prior to third second visit
Intervention: Antioxidant (Dietary Supplement)
Placebo then Antioxidant
Subjects will ingest a placebo prior to their second visit and an antioxidant cocktail prior to their third visit.
Intervention: Antioxidant (Dietary Supplement)
Outcomes
Primary Outcomes
Arm Vascular Function at Rest (Flow Mediated Dilation Test)
Time Frame: Baseline to the end of the final visit, about 2 weeks
Change in Brachial Artery Dilation from Baseline Values
Arm Vascular Function in Response to Exercise (Handgrip Exercise Test)
Time Frame: Baseline to the end of the final visit, about 2 weeks
Change in Brachial Artery Dilation from Baseline Values
Leg Vascular Function (Passive Leg Movement Test)
Time Frame: Baseline to the end of the final visit, about 2 weeks
Change in Leg Blood Flow Values from Baseline
Secondary Outcomes
No secondary outcomes reported