Nitric Oxide and Endothelial Dysfunction in Women With PTSD

This research study is investigating why women with post-traumatic stress disorder (PTSD) may have a higher risk of heart disease later in life. It's looking at how trauma and PTSD affect blood vessels in young women. The study will test if a dietary supplement called Beetroot Juice (James White Beet It sports shot) can improve blood vessel function. Some participants will receive Beetroot Juice, while others will receive a Placebo Juice (James White Nitrate Depleted Placebo). The study aims to enroll 30 women between 18 and 40 years old who are premenopausal and have experienced trauma, with or without PTSD. Success will be measured by changes in Flow Mediated Dilation (FMD), which indicates how well blood vessels expand, after two months. The current recruitment status is unclear.

Study design
This is an interventional study with an unspecified phase, planning to enroll 30 women. Participants will receive either Beetroot Juice or a Placebo Juice.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Month 2, suggesting follow-up for at least two months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07485231

Nitric Oxide (NO) and Endothelial Dysfunction in Women With PTSD

Recruiting
NAAges 18–40InterventionalTreatment
University of Minnesota
~30 participants
Updated 2026-04-03 on ClinicalTrials.gov
What's tested:Beetroot JuicePlacebo Juice

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Flow Mediated Dilation (FMD)
Measured over Month 2
Post Traumatic Stress Disorder
Trauma
1 sites across 1 states
Minnesota1
  • Ida-Arlaine Fonkoue, MD, PhD, MsCR · PRINCIPAL_INVESTIGATOR · University of Minnesota
Ida-Arlaine Fonkoue, MD, PhD, MsCR
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Eligibility criteria

Inclusion

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.
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.

Exclusion

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.
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).
  • Change in Flow Mediated Dilation (FMD)Month 2

    Difference in FMD before and after beetroot juice administration