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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorColorado State University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Low plant diversity beverage
  • Functional Food intervention

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Colorado State University

Lead sponsor

University of Colorado, Denver

Collaborator

University of Utah

Collaborator