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Beetroot juice tested to uncover heart risks in women with PTSD

NCT ID NCT07485231

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Recruiting now This study
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By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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The trial has finished. Results may not be published yet.
Stopped early
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Cancelled before anyone took part.

Expanded access (not trials)

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Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at why women with PTSD have a higher chance of heart disease later in life. Researchers will test if beetroot juice, a natural source of nitric oxide, can improve blood vessel function in 30 premenopausal women who have experienced trauma. The goal is to understand the link between PTSD and blood vessel health, not to treat the condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

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Other studies related to the condition(s) this trial covers.