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

NCT07107269 | Recruiting

• 1 other identifier: 5886
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The gut microbiome has been shown to impact various facets of human health, including mental health. Studies have shown that populations with more agrarian lifestyles tend to have fewer chronic diseases and mental health issues than industrialized populations. A possible factor in these differences is the loss of co-evolved gut microbial taxa that has occurred with Westernization. This hypothesis, termed "Old Friends Hypothesis" suggests that the loss of certain gut microbes leads to immune dysregulation and increased chronic inflammation that contributes to development of cancers, cardiometabolic diseases and even neuroinflammation that can lead to negative behavioral and mental health outcomes. Other studies have shown that increasing the intake of plant foods may help increase diversity of the microbes in the gut and that this increased diversity could lead to better health outcomes in humans. The investigators propose to evaluate daily consumption of a drink consisting of a high diversity of plants (30 plant species) for four weeks on the diversity of the gut microbiome, biological signatures of inflammation, quality of life, sleep quality, and PTSD symptoms among persons with a diagnosis of PTSD. The investigators hypothesize that four weeks of daily consumption of this high plant diversity beverage (30 plant species) will increase gut microbiome ɑ-diversity, reduce markers of systemic inflammation, and improve PTSD symptom severity relative to daily consumption of a beverage containing only three plant species.

Conditions

PTSD - Post Traumatic Stress Disorder

Keywords

PTSD; Post Traumatic Stress Disorder; Highly Diverse Fruit and Vegetable Drink; PTSD and microbiome

Outcome Measures

Primary Outcomes (4)

• Changes in self-assessed severity of post-traumatic stress disorder (PTSD) symptoms

  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.

  From enrollment to the end of the 4-week intervention period.

• Gut Microbiota Richness

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

  From enrollment to the end of the 4-week intervention period.

• Gut microbiota diversity

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

  From enrollment to the end of the 4-week intervention period.

• C-reactive protein in plasma

  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.

  From enrollment to the end of the 4-week intervention period.

Secondary Outcomes (2)

• Seated Blood Pressure

  From enrollment to the end of the 4-week intervention period.

• Changes in T-cell populations

  From enrollment to the end of the 4-week intervention period.

Study Arms (2)

High plant diversity intervention

EXPERIMENTAL

30 different vegetables as a 4 oz blended beverage in a mylar pouch.

Other: Functional Food intervention

Low plant diversity intervention group

EXPERIMENTAL

3 vegetable blend as a 4 oz blended beverage in a mylar pouch.

Other: Low plant diversity beverage

Interventions

Low plant diversity beverage OTHER

Blended drink made from 3 organic vegetables (Power Greens mix)

Low plant diversity intervention group

Functional Food intervention OTHER

This is a 4oz shot made from 30 different organic vegetables and packaged in mylar pouches.

High plant diversity intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults (age 18-65) with a diagnosis of PTSD and a BMI \<35. Participants should be willing to follow the study protocols and attend all clinic visits.

Sponsors & Collaborators

• Colorado State University: lead
• University of Colorado, Denver: collaborator
• University of Utah: collaborator

Study Sites (1)

Food and Nutrition Clinical Research Lab - Colorado State University

Fort Collins, Colorado, 80523, United States

RECRUITING

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Tiffany Weir, PhD

  Colorado State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiffany L Weir, PhD

CONTACT

(970) 491-4631; tiffany.weir@colostate.edu

Jenny Whittington, MS

CONTACT

970-310-6843; ijwhitt@rams.colostate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized, double-blinded, parallel arm, controlled diet intervention

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: August 6, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)