PTSD - Post Traumatic Stress DisorderDMAPSNCT07107269
Diet and Microbiome Interactions: Application in Posttraumatic Stress Disorder in Adults Consuming Vegetable Drinks
A study testing Low diversity plant beverage (Functional Food Intervention) and High diversity plant beverage (Functional Food Intervention) in people with PTSD - Post Traumatic Stress Disorder, run by Colorado State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder
- What is being tested?
- Low diversity plant beverage (Functional Food Intervention) and High diversity plant beverage (Functional Food Intervention)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy adults (18-60 years old)
- Diagnosis of PTSD
- BMI<35
- Willing to follow all study criteria
Who cannot join
- Antibiotic use within 3 months
- BMI of 35 or higher
- Vegan or vegetarian
- Allergies to any intervention beverages
- Unstable medication regimen
- Any gastrointestinal diseases, cancer, CVD, diabetes, autoimmune disease, pregnant or breastfeeding
- Any medication changes within last two months
Trial locations and contacts
1 site in 1 country.
United States1 site
Food and Nutrition Clinical Research Lab - Colorado State University
Fort Collins, Colorado, 80523
About this study
Official title: Diet and Microbiome Interactions: Application in Posttraumatic Stress Disorder
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.
Read the detailed description
The intervention will be a double-blind parallel arm study that consists of a four-week treatment period where participants will be randomized to either the experimental or control arm of the study.
During this four-week treatment period the participants will consume either a 4 oz beverage consisting of 30 different blended vegetables (high diversity treatment) or a similar control beverage consisting of 4 oz of blended Power Greens mix, containing only 3 different plant species (low diversity F\&V treatment).
The participants will be asked to provide 2-day diet records every two weeks throughout the study. Participants will also complete daily bowel movement records using the Bristol Stool Scale (BSS) and collect 3 fecal samples (baseline, mid-point and final) that will be returned to the clinic at scheduled visits. Blood samples and gut, sleep, and mental health questionnaire data will be collected at the beginning and end of the study.
Primary objectives are as follows:
Objective 1: To determine whether consuming a higher number of plant types, thereby increasing exposure to diverse plant-associated microbes, increases gut microbial diversity. Specifically, investigators will use fecal samples from individuals before and after 4-week consumption of a 4 oz beverage made with high (30 different plants) and low botanical diversity (3 different plants) to assess taxonomic richness (CHAO) and diversity (Shannon) using 16s rRNA and metagenomic sequencing approaches.
Objective 2: To determine how differences in plant diversity consumption influence inflammation and immune signatures, specifically plasma hsCRP levels and number/type of circulating T-regulatory cells. hsCRP will be assayed using ELISA and T-cells and other immune cells will be profiled from collected peripheral blood mononucleocytes (PBMCs) via flow cytometry.
Objective 3: To determine whether gut microbial diversity and inflammatory profiles correlate with PTSD symptom severity. PTSD symptoms will be evaluated at each visit using the PCL-5 assessment and changes with treatment as well as correlates with other primary outcome measures will be determined.
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Being tested
- Low diversity plant beverage (Functional Food Intervention), High diversity plant beverage (Functional Food Intervention)
- Keywords
- PTSD, Post Traumatic Stress Disorder, Highly Diverse Fruit and Vegetable Drink, PTSD and microbiome
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low diversity plant beverage (Functional Food Intervention)Other
Blended drink made from 3 organic vegetables (Power Greens mix)
High diversity plant beverage (Functional Food Intervention)Other
This is a 4oz shot made from 30 different organic vegetables and packaged in mylar pouches.
| Study group | Role | What they receive |
|---|---|---|
| High plant diversity intervention | Experimental | 30 different vegetables as a 4 oz blended beverage in a mylar pouch. Receives: Other: High diversity plant beverage (Functional Food Intervention) |
| Low plant diversity intervention | Experimental | 3 vegetable blend as a 4 oz blended beverage in a mylar pouch. Receives: Other: Low diversity plant beverage (Functional Food Intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of the 4-week intervention period.
Gut Microbiota Richness
Microbiota richness will be determined by the number of amplicon sequence variants (actual or estimated) in a fecal sample.
Measured: From enrollment to the end of the 4-week intervention period.
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.
Measured: From enrollment to the end of the 4-week intervention period.
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.
Measured: From enrollment to the end of the 4-week intervention period.
Secondary outcomes (2)
Seated Blood Pressure
Average of 3 seated brachial blood pressure readings taken in the clinic at each visit.
Measured: From enrollment to the end of the 4-week intervention period.
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.
Measured: From enrollment to the end of the 4-week intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start25 Jun 2025
- Primary completion21 Jul 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blinded, parallel arm, controlled diet intervention
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, University of Utah
- Responsible party
- Principal investigator, Tiffany Weir, Colorado State University
- Investigators
- Tiffany Weir, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107269
- Sponsor's protocol ID
- 5886
- Acronym
- DMAPS
- Status last verified
- Sep 2026
- First submitted
- 23 Jul 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet and Microbiome Interactions: Application in Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT07107269
- Acronym / sponsor ID
- DMAPS / 5886
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Keywords
- PTSD, Post Traumatic Stress Disorder, Highly Diverse Fruit and Vegetable Drink, PTSD and microbiome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, University of Utah
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 21 Jul 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The intervention will be a double-blind parallel arm study that consists of a four-week treatment period where participants will be randomized to either the experimental or control arm of the study.
During this four-week treatment period the participants will consume either a 4 oz beverage consisting of 30 different blended vegetables (high diversity treatment) or a similar control beverage consisting of 4 oz of blended Power Greens mix, containing only 3 different plant species (low diversity F\&V treatment).
The participants will be asked to provide 2-day diet records every two weeks throughout the study. Participants will also complete daily bowel movement records using the Bristol Stool Scale (BSS) and collect 3 fecal samples (baseline, mid-point and final) that will be returned to the clinic at scheduled visits. Blood samples and gut, sleep, and mental health questionnaire data will be collected at the beginning and end of the study.
Primary objectives are as follows:
Objective 1: To determine whether consuming a higher number of plant types, thereby increasing exposure to diverse plant-associated microbes, increases gut microbial diversity. Specifically, investigators will use fecal samples from individuals before and after 4-week consumption of a 4 oz beverage made with high (30 different plants) and low botanical diversity (3 different plants) to assess taxonomic richness (CHAO) and diversity (Shannon) using 16s rRNA and metagenomic sequencing approaches.
Objective 2: To determine how differences in plant diversity consumption influence inflammation and immune signatures, specifically plasma hsCRP levels and number/type of circulating T-regulatory cells. hsCRP will be assayed using ELISA and T-cells and other immune cells will be profiled from collected peripheral blood mononucleocytes (PBMCs) via flow cytometry.
Objective 3: To determine whether gut microbial diversity and inflammatory profiles correlate with PTSD symptom severity. PTSD symptoms will be evaluated at each visit using the PCL-5 assessment and changes with treatment as well as correlates with other primary outcome measures will be determined.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blinded, parallel arm, controlled diet intervention
| Arm | Type | Receives |
|---|---|---|
| High plant diversity intervention | Experimental | Other: High diversity plant beverage (Functional Food Intervention)30 different vegetables as a 4 oz blended beverage in a mylar pouch. |
| Low plant diversity intervention | Experimental | Other: Low diversity plant beverage (Functional Food Intervention)3 vegetable blend as a 4 oz blended beverage in a mylar pouch. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adults (18-60 years old)
- Diagnosis of PTSD
- BMI<35
- Willing to follow all study criteria
Key exclusion criteria (7 listed)
- Antibiotic use within 3 months
- BMI of 35 or higher
- Vegan or vegetarian
- Allergies to any intervention beverages
- Unstable medication regimen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low diversity plant beverage (Functional Food Intervention)Blended drink made from 3 organic vegetables (Power Greens mix) | Other | Low plant diversity intervention |
| High diversity plant beverage (Functional Food Intervention)This is a 4oz shot made from 30 different organic vegetables and packaged in mylar pouches. | Other | High plant diversity intervention |
Primary outcome
Changes in self-assessed severity of post-traumatic stress disorder (PTSD) symptoms
Time frame: From enrollment to the end of the 4-week intervention period.
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.
Gut Microbiota Richness
Time frame: From enrollment to the end of the 4-week intervention period.
Microbiota richness will be determined by the number of amplicon sequence variants (actual or estimated) in a fecal sample.
Gut microbiota diversity
Time frame: From enrollment to the end of the 4-week intervention period.
The Shannon-Wiener index will be applied to 16s rRNA amplicon sequence variants to determine microbial community diversity within a fecal sample.
C-reactive protein in plasma
Time frame: From enrollment to the end of the 4-week intervention period.
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.
2 secondary outcomes
Seated Blood Pressure
Time frame: From enrollment to the end of the 4-week intervention period.
Changes in T-cell populations
Time frame: From enrollment to the end of the 4-week intervention period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiffany Weir, PhD principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low diversity plant beverage (Functional Food Intervention) and High diversity plant beverage (Functional Food Intervention) in people with PTSD - Post Traumatic Stress Disorder, run by Colorado State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in self-assessed severity of post-traumatic stress disorder (PTSD) symptoms (time frame: From enrollment to the end of the 4-week intervention period.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.