NCT03216980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 27, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 13, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

3.9 years

First QC Date

June 27, 2017

Last Update Submit

August 24, 2021

Conditions

Mental Health Disorders

Keywords

cardiovascular diseasevascular functionPTSDGAD

Outcome Measures

Primary Outcomes (2)

  • Arm Vascular Function at Rest (Flow Mediated Dilation Test) and in Response to Exercise (Handgrip Exercise Test)

    Change in Brachial Artery Dilation from Baseline Values

    Before and Immediately After Intervention

  • Leg Vascular Function (Passive Leg Movement Test)

    Change in Leg Blood Flow Values from Baseline

    Before and Immediately After Intervention

Study Arms (4)

PTSD/GAD Antioxidant

EXPERIMENTAL

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 AntioxidantDietary Supplement: PTSD/GAD Placebo

PTSD/GAD Placebo

PLACEBO COMPARATOR

Subjects will ingest placebo (microcrystalline cellulose) pills.

Dietary Supplement: PTSD/GAD AntioxidantDietary Supplement: PTSD/GAD Placebo

Healthy Control Antioxidant

EXPERIMENTAL

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 AntioxidantDietary Supplement: Healthy Control Placebo

Healthy Control Placebo

PLACEBO COMPARATOR

Subjects will ingest placebo (microcrystalline cellulose) pills.

Dietary Supplement: Healthy Control AntioxidantDietary Supplement: Healthy Control Placebo

Interventions

PTSD/GAD AntioxidantDIETARY_SUPPLEMENT

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).

PTSD/GAD AntioxidantPTSD/GAD Placebo
PTSD/GAD PlaceboDIETARY_SUPPLEMENT

Subjects will ingest placebo (microcrystalline cellulose) pills.

PTSD/GAD AntioxidantPTSD/GAD Placebo
Healthy Control AntioxidantDIETARY_SUPPLEMENT

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).

Healthy Control AntioxidantHealthy Control Placebo
Healthy Control PlaceboDIETARY_SUPPLEMENT

Subjects will ingest placebo (microcrystalline cellulose) pills.

Healthy Control AntioxidantHealthy Control Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • taking medications that could influence cardiovascular function
  • limited English proficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Ryan Garten, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2017

First Posted

July 13, 2017

Study Start

May 15, 2017

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

August 25, 2021

Record last verified: 2021-08

Locations

US(1)