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

Part of paid clinical trials in Fort Collins, Colorado.

Sponsor
Colorado State University
Study ID
NCT07107269
Status
Recruiting
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Conditions

  • PTSD - Post Traumatic Stress Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Low plant diversity beverage — OTHER
    Blended drink made from 3 organic vegetables (Power Greens mix)
  • Functional Food intervention — OTHER
    This is a 4oz shot made from 30 different organic vegetables and packaged in mylar pouches.

Study Details

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.

Key Dates

Start date
Jun 25, 2025
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: High plant diversity intervention
    30 different vegetables as a 4 oz blended beverage in a mylar pouch.
  • Experimental: Low plant diversity intervention group
    3 vegetable blend as a 4 oz blended beverage in a mylar pouch.

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Food and Nutrition Clinical Research Lab - Colorado State UniversityFort CollinsColorado80523
Tiffany Weir, Ph.D.
[email protected]
970-491-4631
Thomas Aquilino
[email protected]
970-491-4631

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By research site
Food and Nutrition Clinical Research Lab - Colorado State University· Fort Collins, CO

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