Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07107269

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

Led by Colorado State University · Updated on 2025-08-06

40

Participants Needed

1

Research Sites

53 weeks

Total Duration

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Sponsors

C

Colorado State University

Lead Sponsor

U

University of Colorado, Denver

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 65 years
  • Diagnosis of post-traumatic stress disorder (PTSD)
  • Body mass index (BMI) less than 35
  • Willingness to follow study protocols and attend all clinic visits
Not Eligible

You will not qualify if you...

  • Use of antibiotics within the previous three months
  • Body mass index (BMI) greater than 35
  • Following a vegan or vegetarian diet
  • Allergies to any foods in the intervention beverages
  • Unstable medication regimen
  • Diagnosis of gastrointestinal diseases, cancer, cardiovascular disease, diabetes, or autoimmune disease
  • Pregnancy or breastfeeding
  • Medication changes or antibiotic use during the study
  • Inability or unwillingness to adhere to study requirements including daily beverage consumption, providing stool and blood samples, symptom tracking, and attending clinic visits

AI-Screening

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Trial Site Locations

Total: 1 location

1

Food and Nutrition Clinical Research Lab - Colorado State University

Fort Collins, Colorado, United States, 80523

Actively Recruiting

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Research Team

T

Tiffany L Weir, PhD

CONTACT

J

Jenny Whittington, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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