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

ConditionsPost Traumatic Stress Disorder Trauma

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-40

SponsorUniversity of Minnesota

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Beetroot JuiceExperimental treatment 1 intervention

Group B: Placebo JuicePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Change in Flow Mediated Dilation (FMD)

Difference in FMD before and after beetroot juice administration

Time frame

Month 2

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Source ClinicalTrials.gov

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