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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Low plant diversity beverage
Other interventionBlended drink made from 3 organic vegetables (Power Greens mix)
Functional Food intervention
Other interventionThis is a 4oz shot made from 30 different organic vegetables and packaged in mylar pouches.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: High plant diversity interventionExperimental treatment 1 intervention
Group B: Low plant diversity intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes in self-assessed severity of post-traumatic stress disorder (PTSD) symptoms
PTSD Checklist for DSM-5 or the PCL-5 questionnaire. The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including: Monitoring symptom change during and after treatment Screening individuals for PTSD Making a provisional PTSD diagnosis A higher score on the PCL-5 indicates a greater level of distress and impairment associated with PTSD symptoms. The total score ranges from 0 to 80, with higher scores reflecting a more severe symptomatology. A total score of 32 or above suggests the presence of clinically significant PTSD symptoms, which may require further assessment and treatment.
Time frame
From enrollment to the end of the 4-week intervention period.2
Gut Microbiota Richness
Microbiota richness will be determined by the number of amplicon sequence variants (actual or estimated) in a fecal sample.
Time frame
From enrollment to the end of the 4-week intervention period.3
Gut microbiota diversity
The Shannon-Wiener index will be applied to 16s rRNA amplicon sequence variants to determine microbial community diversity within a fecal sample.
Time frame
From enrollment to the end of the 4-week intervention period.4
C-reactive protein in plasma
CRP, or C-reactive protein, is a substance produced by the liver in response to inflammation in the body. It is commonly measured in blood using a high sensitivity ELISA test to assess general inflammation levels, helping to identify underlying health issues such as infections, tissue injury, or chronic inflammatory diseases. Elevated levels of CRP are associated with PTSD.
Time frame
From enrollment to the end of the 4-week intervention period.Secondary outcomes
1
Seated Blood Pressure
Average of 3 seated brachial blood pressure readings taken in the clinic at each visit.
Time frame
From enrollment to the end of the 4-week intervention period.2
Changes in T-cell populations
Using flow cytometry to look at the number and types of T-cells in peripheral blood mononuclear cells can be used to look at changes in immune response and inflammation.
Time frame
From enrollment to the end of the 4-week intervention period.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Colorado State University
Lead sponsor
University of Colorado, Denver
Collaborator
University of Utah
Collaborator
Source ClinicalTrials.gov