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

Sponsor

Virginia Commonwealth University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04916327

Collaborator

(none)

720

Enrollment

Location

Arms

23.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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)).

Condition or Disease	Intervention/Treatment	Phase
Peripheral Vascular Diseases	Dietary Supplement: Antioxidant Dietary Supplement: Placebo	N/A

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

Anticipated Enrollment :

720 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

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

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Aug 23, 2021

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Antioxidant then Placebo

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

Dietary Supplement: 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: Placebo

Subjects will ingest placebo (microcrystalline cellulose) pills.

Experimental: Placebo then Antioxidant

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

Dietary Supplement: 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: Placebo

Subjects will ingest placebo (microcrystalline cellulose) pills.

Outcome Measures

Primary Outcome Measures

Arm Vascular Function at Rest (Flow Mediated Dilation Test) [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) [Baseline to the end of the final visit, about 2 weeks]
Change in Leg Blood Flow Values from Baseline
Arm Vascular Function in Response to Exercise (Handgrip Exercise Test) [Baseline to the end of the final visit, about 2 weeks]
Change in Brachial Artery Dilation from Baseline Values

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 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