Post Traumatic Stress DisorderNCT07485231
Nitric Oxide (NO) and Endothelial Dysfunction in Women With PTSD
A study testing Beetroot Juice in people with Post Traumatic Stress Disorder and Trauma, run by University of Minnesota at 1 site in United States.
Trial summary
This research study is conducted to better understand why women with post-traumatic stress disorder (PTSD) have higher risk of cardiovascular disease as they get older. This study looks at how trauma and PTSD affect blood vessels in young women by testing whether the dietary supplement beetroot juice might help… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Post Traumatic Stress Disorder, Trauma
- What is being tested?
- Beetroot Juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2026to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women ages 18-40 (female as defined biologically)
- Premenopausal as indicated by self-report of menstrual cycles.
- Trauma-exposed with or without PTSD. Diagnostic Criteria for both trauma exposure and PTSD will be obtained via clinical interview, medical records, and self-report.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Diagnosis of major depression (MD).
- Comorbid Psychiatric Conditions: Participants with other anxiety disorders, and bipolar disorder without psychotic features, mild to moderate traumatic brain injury, and borderline personality disorder will be included.
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- Medical records will also assist in the detection of current and lifetime comorbid psychiatric conditions.
- Any over-the-counter medications must be held for 24 hours before each testing visit.
- The PTSD groups must meet DSM-5 diagnostic criteria for PTSD assessed via the CAPS 5 (at least 6 symptoms: 1 B, 1 C, 2 D, and 2 E), with a total severity score of ≥25:
- We will enroll participants as long as they are stable on meds (no changes within the past 3 months). Many participants are often on psychiatric meds, but still have PTSD symptoms. It really isn't that this is an untreated sample. It is more than that it includes people actively symptomatic, regardless of current treatment. Participants will not be required to stop any psychiatric medications.
Who cannot join
- Non-biologically female people who may otherwise identify as women
- Individuals who are taking hormone replacement therapy.
- Pregnant, breastfeeding, or planning to become pregnant during the duration of the study
- Individuals taking any types of hormonal contraceptives.
- Self-reported Medical conditions: hypertension, diabetes, heart disease, vascular disease, ongoing illicit drug use, excessive alcohol use (>2 drinks per day), hyperlipidemia, autonomic dysfunction, any serious systemic disease, gastrointestinal disorders
- Medications for PTSD or other cardiovascular diseases or any medication known to affect vascular function and central sympathetic output, such as antihypertensive medications (beta blockers, calcium channel blockers, angiotensin receptor blockers, angiotensin receptor inhibitors), corticosteroids, direct-acting vasodilators like nitrates and hydralazine, thyroid medications such as carbimazole, thyroxin.
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- Psychiatric Comorbidities: Ongoing substance abuse will be excluded because of the sympathoexcitatory effect of illicit drugs such as cocaine and methamphetamines that exert a powerful pressor and direct sympathoexcitatory effect. A report of a minimum of 6 months of non-drug use (recovery) will be required for those who have a history of illicit drug use
- Psychotic and dissociative disorders will be excluded due to concerns regarding comprehension and adherence.
- The inability or unwillingness to abstain from nicotine use for at least 12 hours prior to physiologic studies (visits 1 and 2), to eliminate sympathoexcitatory effects of nicotine (half-life of 2 hours).
- Any gastrointestinal complications, such as irritable bowel syndrome, and diseases such as celiac disease, irritable bowel syndrome. Any food allergy related to dietary nitrates. Any food allergy to nitrate-containing foods.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Ida-Arlaine Fonkoue, MD, PhD, MsCR, 612-626-2520, fonko001@umn.edu
About this study
Official title: Role of Nitric Oxide (NO) in Endothelial Dysfunction in Premenopausal Women With Posttraumatic Stress Disorder (PTSD)
This research study is conducted to better understand why women with post-traumatic stress disorder (PTSD) have higher risk of cardiovascular disease as they get older. This study looks at how trauma and PTSD affect blood vessels in young women by testing whether the dietary supplement beetroot juice might help improve the function of blood vessels in women suffering from PTSD.
- Conditions
- Post Traumatic Stress Disorder, Trauma
- Being tested
- Beetroot Juice, Placebo Juice
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot JuiceDietary supplement
We will use James White Beet It sports shot (70ml), which contains 400 mg of dietary nitrate
Placebo JuiceDietary supplement
James White Nitrate Depleted Placebo ( 70 ml) will be used as a placebo
| Study group | Role | What they receive |
|---|---|---|
| Beetroot Juice | Experimental | Not described Receives: Dietary Supplement: Beetroot Juice |
| Placebo Juice | Placebo comparator | Not described Receives: Dietary Supplement: Placebo Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Flow Mediated Dilation (FMD)
Difference in FMD before and after beetroot juice administration
Measured: Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start18 Feb 2026
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ida-Arlaine Fonkoue, MD, PhD, MsCR, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485231
- Sponsor's protocol ID
- PT-2025-34371
- Status last verified
- Apr 2026
- First submitted
- 16 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Nitric Oxide (NO) in Endothelial Dysfunction in Premenopausal Women With Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT07485231
- Acronym / sponsor ID
- PT-2025-34371
- Conditions
- Post Traumatic Stress Disorder, Trauma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 20 Mar 2026 (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.
This research study is conducted to better understand why women with post-traumatic stress disorder (PTSD) have higher risk of cardiovascular disease as they get older. This study looks at how trauma and PTSD affect blood vessels in young women by testing whether the dietary supplement beetroot juice might help improve the function of blood vessels in women suffering from PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beetroot Juice | Experimental | Dietary Supplement: Beetroot Juice |
| Placebo Juice | Placebo comparator | Dietary Supplement: Placebo Juice |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Women ages 18-40 (female as defined biologically)
- Premenopausal as indicated by self-report of menstrual cycles.
- Trauma-exposed with or without PTSD. Diagnostic Criteria for both trauma exposure and PTSD will be obtained via clinical interview, medical records, and self-report.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Diagnosis of major depression (MD).
Key exclusion criteria (10 listed)
- Non-biologically female people who may otherwise identify as women
- Individuals who are taking hormone replacement therapy.
- Pregnant, breastfeeding, or planning to become pregnant during the duration of the study
- Individuals taking any types of hormonal contraceptives.
- Self-reported Medical conditions: hypertension, diabetes, heart disease, vascular disease, ongoing illicit drug use, excessive alcohol use (>2 drinks per day), hyperlipidemia, autonomic dysfunction, any serious systemic disease, gastrointestinal disorders
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 |
|---|---|---|
| Beetroot JuiceWe will use James White Beet It sports shot (70ml), which contains 400 mg of dietary nitrate | Dietary supplement | Beetroot Juice |
| Placebo JuiceJames White Nitrate Depleted Placebo ( 70 ml) will be used as a placebo | Dietary supplement | Placebo Juice |
Primary outcome
Change in Flow Mediated Dilation (FMD)
Time frame: Month 2
Difference in FMD before and after beetroot juice administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
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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.
Ida-Arlaine Fonkoue, MD, PhD, MsCR principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot Juice in people with Post Traumatic Stress Disorder and Trauma, run by University of Minnesota 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 10 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 3 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ida-Arlaine Fonkoue, MD, PhD, MsCR (612-626-2520, fonko001@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Flow Mediated Dilation (FMD) (time frame: Month 2). 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 3 Apr 2026.