Microbiome, Anxiety and Cognitive Orientation Study

NCT05388630 | Unknown

• 1 other identifier: 04012022
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Microbiome; Mood Disorders; Neurodegeneration; Depression

Keywords

Lifestyle; Gut bacteria; 4-ethylphenyl sulfate 4EPS; Cognitive Orientation; Gut Brain Axis; Microbiome; Anxiety; Depression

Outcome Measures

Primary Outcomes (5)

• 4EPS

  Stool samples will be lab processed and analyzed for 4-EPS levels

  up to 2 weeks

• Cognitive Orientation Social-Emotional Competency (COSEC) Assessment

  An online cognitive propensity and behavioral preference diagnostic tool. COSEC is designed to understand people's various tendencies that occur during the process between perceiving the environment and responding in action. It illustrates an individual's personality and aptitude as an outcome shaped by their environment and the perception of the world around them. COSEC incorporates the environmental impact on the individual by looking at the unique process of a person's perception, conception, and behavior process. Assessments are scored using an algorithm to generate quantified measurements based on multifactorial relationships between a subject's responses. Results are presented in a descriptive format, called the COBI Report (Cognitive Orientation Behavior Inventory).

  up to 1 week

• Anxiety Assessment

  GAD-7: Generalized Anxiety Disorder 7 is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. Scores of 5, 10, and 15 represent cut points for mild, moderate, and severe anxiety, respectively.

  up to 1 week

• Depression Assessment

  PHQ-9: Patient Health Questionnaire is a self-administered, 9 question diagnostic tool that rates depression using 9 DSM-V criteria for depression based on the mood.A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression.

  up to 1 week

• Lifestyle and Health Survey

  Demographic, health, and lifestyle data.

  up to 1 week

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Nationwide population of adults 18 years of age and older. Participation is fully remote.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Endominance: lead
• Dr. John J. Ratey: collaborator
• HEM Pharma Inc.: collaborator

Study Sites (1)

Endominance Inc.

Irvine, California, 92618, United States

RECRUITING

Related Links

• Research Study Landing Page

Biospecimen

Retention: SAMPLES WITHOUT DNA

4-ethylphenyl sulfate (4EPS) is a molecule produced by gut microbes in mice and humans. An enzyme in the colon and liver converts 4EP to 4EPS, allowing it to circulate in the blood. Research has shown that higher 4EPS levels may strongly be associated with anxiety levels in both humans and mice, through its degenerative effects on oligodendrocyte function and myelin patterning in the brain. This metabolite can be measured in stool and blood.

MeSH Terms

Conditions

Anxiety Disorders; Mood Disorders; Nerve Degeneration; Depression; Orientation, Spatial

Condition Hierarchy (Ancestors)

Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Spatial Behavior

Central Study Contacts

Endominance Inc.

CONTACT

1-855-788-3955; microbiome.study@endominance.com

Please visit: www.endominance.com/maco_study

CONTACT

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 24, 2022
• Study Start: June 1, 2022
• Primary Completion: April 11, 2023
• Study Completion: May 30, 2023
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)