NCT07485231 Nitric Oxide (NO) and Endothelial Dysfunction in Women With PTSD
| NCT ID | NCT07485231 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | Post Traumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-02-18 |
| Primary Completion | 2028-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2026-02-18 with a primary completion date of 2028-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 improve the function of blood vessels in women suffering from PTSD.
Eligibility Criteria
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.
Contact & Investigator
Ida-Arlaine Fonkoue, MD, PhD, MsCR
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT07485231 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Post Traumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07485231 currently recruiting?
Yes, NCT07485231 is actively recruiting participants. Contact the research team at fonko001@umn.edu for enrollment information.
Where is the NCT07485231 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT07485231 clinical trial?
NCT07485231 is sponsored by University of Minnesota. The principal investigator is Ida-Arlaine Fonkoue, MD, PhD, MsCR at University of Minnesota. The trial plans to enroll 30 participants.