High-diversity vegetable drink for adults with PTSD

Diet and Microbiome Interactions: Application in Posttraumatic Stress Disorder

This will test whether adults with PTSD who drink a daily high-diversity vegetable beverage for four weeks see an increase in gut microbiome diversity compared with a low-diversity drink.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Colorado State University (Academic / other)
• Locations: 1 site (Fort Collins, Colorado)
• Trial ID: NCT07107269 on ClinicalTrials.gov

What this trial studies

This is a double-blind, randomized, parallel-arm intervention in which adults with PTSD consume either a 4 oz beverage made from 30 different plants (high diversity) or a 4 oz control beverage made from 3 plant species (low diversity) for four weeks. Participants provide fecal samples at baseline, mid-point, and end of treatment for 16S rRNA and metagenomic sequencing to measure taxonomic richness and diversity, plus blood samples and standardized questionnaires on gut, sleep, and mental health. Diet is tracked with 2-day diet records every two weeks and daily bowel movement logs using the Bristol Stool Scale. Medication stability is required and recent antibiotic use or certain medical conditions exclude participants.

Who should consider this trial

Good fit: Adults aged 18–65 with a diagnosis of PTSD, BMI under 35, willing to follow protocol and attend in-person visits, not on recent antibiotics, and not following a vegan/vegetarian diet are ideal candidates.

Not a fit: People with recent antibiotic use, BMI over 35, active gastrointestinal, autoimmune, cardiometabolic diseases, pregnancy or breastfeeding, vegan/vegetarian diets, or unstable medication regimens may not receive benefit or be eligible.

Why it matters

Potential benefit: If successful, the intervention could increase gut microbial diversity and potentially reduce inflammation or improve behavioral and mental health outcomes in adults with PTSD.

How similar studies have performed: Prior research shows plant-rich diets can increase gut microbial diversity, but randomized beverage interventions targeting microbiome changes specifically in PTSD are novel.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Fort Collins, Colorado

• Food and Nutrition Clinical Research Lab - Colorado State University — Fort Collins, Colorado, United States (Recruiting)

Study contacts

• Principal investigator: Tiffany Weir, PhD — Colorado State University
• Study coordinator: Tiffany L Weir, PhD

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