Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07107269

Diet and Microbiome Interactions: Application in Posttraumatic Stress Disorder

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

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

C

Colorado State University

Lead Sponsor

U

University of Colorado, Denver

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research investigates how the gut microbiome affects mental health, focusing on adults with post-traumatic stress disorder (PTSD). It explores the "Old Friends Hypothesis," which suggests that losing certain gut microbes due to modern lifestyles may lead to immune problems and inflammation, contributing to health issues like PTSD. The study aims to see if increasing the variety of plants consumed can improve gut microbial diversity and reduce PTSD symptoms. Participants will be randomly assigned to one of two groups in a double-blind setup for four weeks. One group will drink a 4 oz beverage made from 30 different blended vegetables (high plant diversity), while the other will consume a similar 4 oz beverage made from only 3 plant species (low plant diversity). Throughout the study, participants will maintain diet records every two weeks and record daily bowel movements using the Bristol Stool Scale. They will provide stool samples at the start, midpoint, and end of the study. Researchers will collect blood samples and complete questionnaires on sleep, mental health, and quality of life at the beginning and end of the study. They will measure changes in PTSD symptom severity, gut microbiome diversity, blood markers of inflammation like C-reactive protein, and immune cell profiles. The study will monitor participants closely during the four-week intervention to understand how plant diversity in the diet relates to mental and physical health outcomes.

CONDITIONS

Brief 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
  • Diagnosed with post-traumatic stress disorder (PTSD)
  • Body mass index (BMI) less than 35
  • Willing to follow study protocols and attend all clinic visits
Not Eligible

You will not qualify if you...

  • Antibiotic use within the previous three months
  • Body mass index (BMI) greater than 35
  • Vegan or vegetarian diet
  • Allergies to any foods in the intervention beverages
  • Unstable medication regimen
  • Diagnosis of gastrointestinal diseases, cancer, cardiovascular disease, diabetes, 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, sample collection, and clinic visits

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 weeks

Participants consume either a 4 oz beverage made from 30 different vegetables or a 4 oz beverage made from 3 vegetables daily for four weeks. They complete daily bowel movement records and provide diet records every two weeks. Blood samples, fecal samples, and questionnaire data are collected at the beginning and end of treatment.

3 visits (baseline, midpoint, and end of treatment)

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

J

Jenny Whittington, MS

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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