Clinical trial NCT05388630: Microbiome, Anxiety and Cognitive Orientation Study
Official title: The Impact of a Gut-derived Metabolite on Anxiety Behavior of Human Subjects Based on Their Cognitive Orientation Variation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anxiety
Microbiome
Mood Disorders
Neurodegeneration
Depression
Keywords: Lifestyle
Gut bacteria
4-ethylphenyl sulfate 4EPS
Cognitive Orientation
Gut Brain Axis
Microbiome
Anxiety
Depression
Lead sponsor: Endominance
Sponsor class: INDUSTRY
Collaborators: name: Dr. John J. Ratey
name: HEM Pharma Inc.
First posted: 2022-05-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nationwide population of adults 18 years of age and older. Participation is fully remote.

Brief summary: Mounting evidence shows that the gut microbiome plays an important role in communication within the gut-brain axis. However, the relationship between gut microbiota and their influence on anxiety is still not fully understood. Recent studies on mice found a specific microbe-produced molecule, 4-ethylphenyl sulfate (4EPS), can induce anxious behavior. 4EPS is produced by gut microbes in mice and humans. Research suggests higher 4EPS levels may strongly be associated with anxiety levels. However, anxiety is far more complicated than changes in a single molecule. There are many more factors to consider when it comes to anxiety, including various aspects of one's lifestyle and how humans perceive their environment (cognitive orientation). The primary research goal is to better understand the effects 4EPS has on human anxiety behavior and the role cognitive orientation has in connection to anxiety.

Detailed description: This study aims to expand and improve upon previous research on gut bacteria and their connections to anxiety. The Investigators will examine the gut microbiota and its vital role in the gut-brain axis, the link between a gut-derived bacteria (4EPS) and anxiety, and the connections between cognitive orientation and anxiety. It is hypothesized that even though higher 4EPS levels may be associated with anxiety levels in humans, such levels may be more prominent (severe) or less pronounced (less severe) in humans with variations in lifestyle and cognitive orientation.

Cross-sectional data will be compiled from a cognitive assessment (COSEC), a health/lifestyle survey, a generalized anxiety questionnaire, a depression questionnaire, and a stool sample. Stool samples will be analyzed for 4EPS levels. Using the COSEC assessment, we will divide the subjects into nine groups of unique cognitive styles based on their perception and conception scores. Then, depending on their 4EPS level and their survey responses, the relationship between the level of 4EPS and their cognitive traits will be analyzed. COSEC is a cognitive propensity and behavioral preference diagnostic tool designed to understand people's various tendencies that occur during the process of perceiving the environment and responding in action.

The long-term goal of this project is to find connections in the gut-brain axis and gain a deeper understanding of microbiome metabolites as neurodegenerative agents, as they affect anxiety levels in humans. No other studies have been performed to date combining these research areas or their impacts on humans.

Eligibility criteria: Inclusion Criteria:

* Participants must be 18 years of age and older
* Participants must be able to read and write English
* Participants must be able to provide consent independently
* Participants must provide a legitimate postal address/P.O Box
* Participants must have access to a device such as a computer or a smartphone

Exclusion Criteria

-Unable to provide a stool sample due to health status or functional impairment

Primary outcomes:
measure: 4EPS
timeFrame: up to 2 weeks
measure: Cognitive Orientation Social-Emotional Competency (COSEC) Assessment
timeFrame: up to 1 week
measure: Anxiety Assessment
timeFrame: up to 1 week
measure: Depression Assessment
timeFrame: up to 1 week
measure: Lifestyle and Health Survey
timeFrame: up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Endominance Inc.
state: California
Study officials:
References: