RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Diet and Microbiome Interactions: Application in Posttraumatic Stress Disorder

Quick Facts

Study Start:2025-06-25
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07107269

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  1. * Exclusion criteria include antibiotic use within the previous three months, BMI\>35, vegan or vegetarian diet, allergies to any of the foods included in the intervention beverages, an unstable medication regimen, and diagnosis of diseases such as gastrointestinal diseases, cancer, CVD, diabetes or autoimmune disease and pregnancy or breastfeeding. Specific medication use (other than antibiotics) would not disqualify an individual if they have had a stable medication regimen for at least two months prior to beginning the study and remain on their medication for the study duration. However, medication changes or antibiotic use during the study would be a reason for dismissal Additionally, inclusion or exclusion in the study will be determined case-by-case based on self-reported supplement use or if the individual feels they are unable to adhere to the study requirements, which includes consuming beverages daily, providing stool or blood samples, tracking bowel movements and symptoms, and attending scheduled clinic visits.

Contacts and Locations

Study Contact

Tiffany L Weir, PhD
CONTACT
(970) 491-4631
tiffany.weir@colostate.edu
Jenny Whittington, MS
CONTACT
970-310-6843
ijwhitt@rams.colostate.edu

Principal Investigator

Tiffany Weir, PhD
PRINCIPAL_INVESTIGATOR
Colorado State University

Study Locations (Sites)

Food and Nutrition Clinical Research Lab - Colorado State University
Fort Collins, Colorado, 80523
United States

Collaborators and Investigators

Sponsor: Colorado State University

  • Tiffany Weir, PhD, PRINCIPAL_INVESTIGATOR, Colorado State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-25
Study Completion Date2026-07

Study Record Updates

Study Start Date2025-06-25
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • PTSD - Post Traumatic Stress Disorder