Who is eligible for clinical trial NCT07485231?

Participants must meet the protocol's inclusion criteria for Post Traumatic Stress Disorder. The stated age range is 18 Years to 40 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT07485231 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-02

Nitric Oxide (NO) and Endothelial Dysfunction in Women With PTSD (NCT07485231)

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

🟢 Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: University of Minnesota

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (10 items).

Location: University of Minnesota — Minneapolis, Minnesota

Age range: 18 Years to 40 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of Minnesota — Minneapolis, Minnesota

📞 Contact the Study Coordinator

Phone: (612) 626-2520

Email: fonko001@umn.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗