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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Peripheral Vascular Diseases

Intervention / Treatment
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* Dietary Supplement: Antioxidant
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antioxidant then Placebo<br>Subjects will ingest an antioxidant cocktail prior to their second visit and a placebo prior to third second visit | Dietary Supplement: Antioxidant<br>* 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).<br>Dietary Supplement: Placebo<br>* Subjects will ingest placebo (microcrystalline cellulose) pills.<br>|
| Experimental: Placebo then Antioxidant<br>Subjects will ingest a placebo prior to their second visit and an antioxidant cocktail prior to their third visit. | Dietary Supplement: Antioxidant<br>* 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).<br>Dietary Supplement: Placebo<br>* Subjects will ingest placebo (microcrystalline cellulose) pills.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arm Vascular Function at Rest (Flow Mediated Dilation Test) | Change in Brachial Artery Dilation from Baseline Values | Baseline to the end of the final visit, about 2 weeks | 
| Leg Vascular Function (Passive Leg Movement Test) | Change in Leg Blood Flow Values from Baseline | Baseline to the end of the final visit, about 2 weeks | 
| Arm Vascular Function in Response to Exercise (Handgrip Exercise Test) | Change in Brachial Artery Dilation from Baseline Values | Baseline to the end of the final visit, about 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular disease, vascular function, PTSD, GAD, Oxidant