Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07485231

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Ida-Arlaine Fonkoue, MD, PhD, MsCR

CONTACT

[email protected]

612-626-2520

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Exclusion criteria

  • 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).

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.

Treatment and study plan

Beetroot juice

Dietary Supplement

We will use James White Beet It sports shot (70ml), which contains 400 mg of dietary nitrate

Placebo Juice

Dietary Supplement

James White Nitrate Depleted Placebo ( 70 ml) will be used as a placebo

Primary outcomes

  1. Change in Flow Mediated Dilation (FMD)

    Time frame: Month 2

    Difference in FMD before and after beetroot juice administration

Study contacts

Contact information is provided by the study sponsor or research team.

Ida-Arlaine Fonkoue, MD, PhD, MsCR

CONTACT

[email protected]

612-626-2520

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Role of Nitric Oxide (NO) in Endothelial Dysfunction in Premenopausal Women With Posttraumatic Stress Disorder (PTSD)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 20, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.