NCT07107269

Diet and Microbiome Interactions: Application in Posttraumatic Stress Disorder in Adults Consuming Vegetable Drinks

Active, Not Recruiting
NAAges 18–60InterventionalSupportive care
Colorado State University
~40 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:Low diversity plant beverage (Functional Food Intervention)High diversity plant beverage (Functional Food Intervention)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in self-assessed severity of post-traumatic stress disorder (PTSD) symptoms
Measured over From enrollment to the end of the 4-week intervention period.
+3 more outcomes measured
PTSD - Post Traumatic Stress Disorder
1 sites across 1 states
Colorado1
  • Tiffany Weir, PhD · PRINCIPAL_INVESTIGATOR · Colorado State University

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Healthy adults (18-60 years old)
Diagnosis of PTSD
BMI\<35
Willing to follow all study criteria

Exclusion

Antibiotic use within 3 months
BMI of 35 or higher
Vegan or vegetarian
Allergies to any intervention beverages
Unstable medication regimen
Any gastrointestinal diseases, cancer, CVD, diabetes, autoimmune disease, pregnant or breastfeeding
Any medication changes within last two months
  • Changes in self-assessed severity of post-traumatic stress disorder (PTSD) symptomsFrom enrollment to the end of the 4-week intervention period.

    PTSD Checklist for DSM-5 or the PCL-5 questionnaire. The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including: Monitoring symptom change during and after treatment Screening individuals for PTSD Making a provisional PTSD diagnosis A higher score on the PCL-5 indicates a greater level of distress and impairment associated with PTSD symptoms. The total score ranges from 0 to 80, with higher scores reflecting a more severe symptomatology. A total score of 32 or above suggests the presence of clinically significant PTSD symptoms, which may require further assessment and treatment.

  • Gut Microbiota RichnessFrom enrollment to the end of the 4-week intervention period.

    Microbiota richness will be determined by the number of amplicon sequence variants (actual or estimated) in a fecal sample.

  • Gut microbiota diversityFrom enrollment to the end of the 4-week intervention period.

    The Shannon-Wiener index will be applied to 16s rRNA amplicon sequence variants to determine microbial community diversity within a fecal sample.

  • C-reactive protein in plasmaFrom enrollment to the end of the 4-week intervention period.

    CRP, or C-reactive protein, is a substance produced by the liver in response to inflammation in the body. It is commonly measured in blood using a high sensitivity ELISA test to assess general inflammation levels, helping to identify underlying health issues such as infections, tissue injury, or chronic inflammatory diseases. Elevated levels of CRP are associated with PTSD.