Mental Health DisordersNCT03216980
Examining the Effect of Mental Health Disorders on Vascular Function and Exercise Tolerance
A study testing PTSD/GAD Antioxidant in people with Mental Health Disorders, run by Virginia Commonwealth University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Disorders
- What is being tested?
- PTSD/GAD Antioxidant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2017to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- taking medications that could influence cardiovascular function
- limited English proficiency
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
Read the detailed description
Mental health disorders are highly prevalent and underdiagnosed and can cause perturbations in cardiovascular and metabolic function leading to substantial individual burden (increased health care cost, loss of work productivity). Post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD), two common mental health disorders, can cause increase cardiovascular disease risk due to chronic increases or fluctuations in heart rate, blood pressure, stress hormones, inflammation, and oxidative stress. Post-traumatic stress disorder (PTSD) is a disabling psychiatric condition characterized by a persistent maladaptive reaction resulting from exposure to severe psychological stress. It has been revealed that individuals with PTSD, in addition to adverse mental health symptoms, also possess higher prevalence rates for physical comorbidities such as hypertension, obesity, diabetes, and metabolic syndrome. Taken together, these PTSD-induced comorbidities result in a significant increase in the likelihood of developing cardiovascular disease (CVD) when compared to individuals without PTSD. Anxiety disorders, the most prevalent mental health issue in the United States, is associated an increased incidence of hypertension and heart disease. This increased cardiovascular disease (CVD) risk is thought to derive from an overactivation of the sympathetic nervous system that results in a predominately pro-oxidant, pro-inflammatory cardiovascular environment. Peripheral vascular dysfunction, or the inability of the blood vessels to adequately respond to specific stimuli, is a factor closely related to CVD. Therefore, this study will focus on a younger population with PTSD or GAD in an attempt to ascertain the presence of peripheral vascular dysfunction and the magnitude to which two potential primary contributors (autonomic dysfunction, oxidative stress) are involved in this dysfunction.
- Conditions
- Mental Health Disorders
- Being tested
- PTSD/GAD Antioxidant, PTSD/GAD Placebo, Healthy Control Antioxidant, Healthy Control Placebo
- Keywords
- cardiovascular disease, vascular function, PTSD, GAD
- Medical subject headings
- Cardiovascular Diseases, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 PlaceboDietary supplement
Subjects will ingest placebo (microcrystalline cellulose) pills.
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 PlaceboDietary supplement
Subjects will ingest placebo (microcrystalline cellulose) pills.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Dietary Supplement: PTSD/GAD Antioxidant; Dietary Supplement: PTSD/GAD Placebo |
| PTSD/GAD Placebo | Placebo comparator | Subjects will ingest placebo (microcrystalline cellulose) pills. Receives: Dietary Supplement: PTSD/GAD Antioxidant; Dietary 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). Receives: Dietary Supplement: Healthy Control Antioxidant; Dietary Supplement: Healthy Control Placebo |
| Healthy Control Placebo | Placebo comparator | Subjects will ingest placebo (microcrystalline cellulose) pills. Receives: Dietary Supplement: Healthy Control Antioxidant; Dietary Supplement: Healthy Control Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Before and Immediately After Intervention
Leg Vascular Function (Passive Leg Movement Test)
Change in Leg Blood Flow Values from Baseline
Measured: Before and Immediately After Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start15 May 2017
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health DisordersStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Garten, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216980
- Sponsor's protocol ID
- HM20009929
- Status last verified
- Aug 2021
- First submitted
- 27 Jun 2017
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of Mental Health Disorders on Vascular Function and Exercise Tolerance
- ClinicalTrials.gov ID
- NCT03216980
- Acronym / sponsor ID
- HM20009929
- Conditions
- Mental Health Disorders
- Keywords
- cardiovascular disease, vascular function, PTSD, GAD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 13 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Mental health disorders are highly prevalent and underdiagnosed and can cause perturbations in cardiovascular and metabolic function leading to substantial individual burden (increased health care cost, loss of work productivity). Post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD), two common mental health disorders, can cause increase cardiovascular disease risk due to chronic increases or fluctuations in heart rate, blood pressure, stress hormones, inflammation, and oxidative stress. Post-traumatic stress disorder (PTSD) is a disabling psychiatric condition characterized by a persistent maladaptive reaction resulting from exposure to severe psychological stress. It has been revealed that individuals with PTSD, in addition to adverse mental health symptoms, also possess higher prevalence rates for physical comorbidities such as hypertension, obesity, diabetes, and metabolic syndrome. Taken together, these PTSD-induced comorbidities result in a significant increase in the likelihood of developing cardiovascular disease (CVD) when compared to individuals without PTSD. Anxiety disorders, the most prevalent mental health issue in the United States, is associated an increased incidence of hypertension and heart disease. This increased cardiovascular disease (CVD) risk is thought to derive from an overactivation of the sympathetic nervous system that results in a predominately pro-oxidant, pro-inflammatory cardiovascular environment. Peripheral vascular dysfunction, or the inability of the blood vessels to adequately respond to specific stimuli, is a factor closely related to CVD. Therefore, this study will focus on a younger population with PTSD or GAD in an attempt to ascertain the presence of peripheral vascular dysfunction and the magnitude to which two potential primary contributors (autonomic dysfunction, oxidative stress) are involved in this dysfunction.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PTSD/GAD Antioxidant | Experimental | Dietary Supplement: PTSD/GAD Antioxidant, Dietary Supplement: PTSD/GAD PlaceboSubjects 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 Placebo | Placebo comparator | Dietary Supplement: PTSD/GAD Antioxidant, Dietary Supplement: PTSD/GAD PlaceboSubjects will ingest placebo (microcrystalline cellulose) pills. |
| Healthy Control Antioxidant | Experimental | Dietary Supplement: Healthy Control Antioxidant, Dietary Supplement: Healthy Control PlaceboSubjects 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 Placebo | Placebo comparator | Dietary Supplement: Healthy Control Antioxidant, Dietary Supplement: Healthy Control PlaceboSubjects will ingest placebo (microcrystalline cellulose) pills. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- taking medications that could influence cardiovascular function
- limited English proficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTSD/GAD AntioxidantSubjects 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 Antioxidant, PTSD/GAD Placebo |
| PTSD/GAD PlaceboSubjects will ingest placebo (microcrystalline cellulose) pills. | Dietary supplement | PTSD/GAD Antioxidant, PTSD/GAD Placebo |
| Healthy Control AntioxidantSubjects 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 Antioxidant, Healthy Control Placebo |
| Healthy Control PlaceboSubjects will ingest placebo (microcrystalline cellulose) pills. | Dietary supplement | Healthy Control Antioxidant, Healthy Control Placebo |
Primary outcome
Arm Vascular Function at Rest (Flow Mediated Dilation Test) and in Response to Exercise (Handgrip Exercise Test)
Time frame: Before and Immediately After Intervention
Change in Brachial Artery Dilation from Baseline Values
Leg Vascular Function (Passive Leg Movement Test)
Time frame: Before and Immediately After Intervention
Change in Leg Blood Flow Values from Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
Related trials for Mental Health Disorders
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Garten, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTSD/GAD Antioxidant in people with Mental Health Disorders, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arm Vascular Function at Rest (Flow Mediated Dilation Test) and in Response to Exercise (Handgrip Exercise Test) (time frame: Before and Immediately After Intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.