Microbiome, Anxiety and Cognitive Orientation Study (MACO)

The Impact of a Gut-derived Metabolite on Anxiety Behavior of Human Subjects Based on Their Cognitive Orientation Variation

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Mood Disorders; Anxiety; Microbiome; Neurodegeneration

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.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Endominance Inc.; Phone Number: 1-855-788-3955; Email: microbiome.study@endominance.com
• Study Contact Backup: Name: Please visit: www.endominance.com/maco_study

Study Locations

• United States
  • California
    • Irvine, California, United States, 92618
      • Recruiting
      • Endominance Inc.
      • Contact: Endominance Research Team; Phone Number: 855-788-3955; Email: microbiome.study@endominance.com
      • Principal Investigator: John J Ratey, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Endominance
• Collaborators: Dr. John J. Ratey; HEM Pharma Inc.

Publications and helpful links

Helpful Links

• Research Study Landing Page

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Anticipated): April 11, 2023
• Study Completion (Anticipated): May 30, 2023

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Estimate): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Depression; Microbiome; Anxiety; Lifestyle; Cognitive Orientation; Gut bacteria; 4-ethylphenyl sulfate 4EPS; Gut Brain Axis
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Depression; Anxiety Disorders; Mood Disorders; Nerve Degeneration
• Other Study ID Numbers: 04012022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: All data will be anonymized and shared in aggregate data sets.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No