Discrimination and the Brain-Gut-Microbiome (BGM) Axis

January 8, 2025 updated by: Arpana Church, University of California, Los Angeles

Social Isolation and Discrimination as Stressors Influencing BGM Alterations

Obesity is a major public health problem related to a variety of illnesses such as heart disease and diabetes. Prior research indicates that social stressors contribute to risk for obesity, possibly through alterations in diet and physical activity. However, it is not fully clear how these alterations contribute to obesity. The purpose of this study is to examine how the stressors of social isolation and discrimination relate to eating behaviors and dietary patterns, and further, how these behaviors affect the brain-gut-microbiome (BGM) connections. This study will focus on Mexican and Filipina women because research shows that they encounter a high burden of obesity and exposure to social stressors. Approximately 300 Mexican and Filipina women will be screened and enrolled. They will then provide information about social stressors via food diaries, physical body measures (e.g. waist circumference), questionnaire data regarding diet and eating behaviors, and measures of physical activity. Stool and serum will be collected to analyze microbes and metabolomics, and MRI to assess brain changes in the reward network. Analytic techniques will be used to integrate data from these multiple data sources. This analysis will determine the unique differences associated with ethnicity and social stressors in moderating eating behaviors and dietary patterns. The results of this study will provide new information about a possible pathway whereby social stressors affect behavioral, neurological and microbiome mechanisms related to obesity risk and provide new information in BGM patterns in two understudied ethnic groups. In the long term, this research may suggest possible approaches for intervention that may help reduce inequalities in obesity and related health problems.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
266

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants recruited from the greater Los Angeles Mexican & Filipina female population.

Description

Inclusion Criteria:

  • Premenopausal females
  • Ages 18-50
  • Mexican or Filipino ancestry
  • BMI 19-40
  • Fluent in English
  • Right-handed

Exclusion Criteria:

Co-Morbidities including but not limited to:

  • Type I diabetes (insulin dependent)
  • Vascular disease
  • Drastic weight loss (more than 10lbs over the preceding 2months)
  • Frequent Strenuous exercise (i.e. marathon runners/heavy weight lifting)
  • Abdominal surgeries including weight loss surgery, or partial/complete resection of the stomach or bowel
  • Untreated thyroid disease
  • Neurological disease
  • Major medical condition that may put the subject at risk or interfere with data collection as determined by the PI/MD
  • Chronic pain
  • Diagnosed DSM IV active psychiatric illness including eating disorders. Must not be active or present for at least 2 years.
  • Use of medications known to affect hunger, satiety, and/or appetite.
  • Unable to safely participate in the MRI (claustrophobia, presence of devices affected by MRI such as pacemakers, neurostimulators, or any metallic foreign body, etc.)
  • Pregnant, lactating, postpartum less than 6mo
  • Women of childbearing age who are not practicing birth control or are planning to get pregnant during the study.
  • Body weight at enrollment greater than 400lbs due to weight restrictions on the MRI table
  • Use of oral/IV antibiotics within the last 3 months
  • Use of probiotics in the last month
  • Heavy use of tobacco, alcohol, and/or drug use/abuse
  • Significant change in usual diet and/or weight loss of more than 10lbs in the last 2months
  • Refugees or recent immigration of less than 2 years in the USA.
  • Temporary workers/visitors/students
  • Recent international travel if more than 3 weeks within the last 3 months.

Use of the following medications is exclusionary:

  • Opiates/narcotics
  • Chronic daily use of high dose OTC analgesics
  • Anti-seizure medications
  • Medications for appetite suppression
  • Chronic use of laxatives/antidiarrheals, medications affecting GI motility
  • Insulin
  • Bile Acid Sequestrants
  • Centrally acting medications that will interfere with the neuroimaging testing
  • Thyroid replacement medications (OK if stable for at least 3mo)
  • Heavy use of tobacco/cannabis
  • Heavy use of alcohol ( >7/week for women)
  • Antidepressants (5HT3's/Tricyclics) (OK if stable for at least 3mo)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Mexican Women
Mexican, premenopausal women ages 18-50.
Filipina Women
Filipina, premenopausal women ages 18-50.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Multimodal Brain Signatures
Time Frame: Measured once at Visit 2. Scan lasts about 1.5 hour.
Neuroimaging of participants brain via MRI procedure.
Measured once at Visit 2. Scan lasts about 1.5 hour.
Microbiome - Stool
Time Frame: Collected twice by the participant at home between Visit 1 and Visit 2, lasting no more than 2 weeks after the first appointment.
Measurement of 16S RNA, shotgun metagenomics, and metabolomics via stool specimen.
Collected twice by the participant at home between Visit 1 and Visit 2, lasting no more than 2 weeks after the first appointment.
Microbiome - Blood
Time Frame: Collected once at Day1.
Measurement of 16S RNA, shotgun metagenomics, and metabolomics via blood specimen.
Collected once at Day1.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Systolic and Diastolic Blood Pressure
Time Frame: Measured once at Day 1.
Measurement of the pressure of circulating blood at rest.
Measured once at Day 1.
Questionnaire Data - Diet
Time Frame: Self-reported by the participant at home between Visit 1 and Visit 2, lasting no more than 2 weeks after the first appointment.
Use of validated surveys including the Food Frequency questionnaire, Food choice questionnaire.
Self-reported by the participant at home between Visit 1 and Visit 2, lasting no more than 2 weeks after the first appointment.
Questionnaire Data - Stressors
Time Frame: Self-reported by the participant at home between Visit 1 and Visit 2, lasting no more than 2 weeks after the first appointment.
Use of validated surveys including, Social isolation scale, Social network engagement, Family cohesion, Acculturative stress, Perceived stress scale, Everyday Discrimination, and major discrimination.
Self-reported by the participant at home between Visit 1 and Visit 2, lasting no more than 2 weeks after the first appointment.
Anthropometrics - waist & hip circumference
Time Frame: Measured once at Day 1.
Measurement of waist and hip circumference(cm).
Measured once at Day 1.
Anthropometrics - BMI
Time Frame: Measured once at Day 1.
Measurement of height(in) and weight(lbs), used to calculate BMI.
Measured once at Day 1.
Questionnaire Data - Physical Activity
Time Frame: Self-reported by the participant at home between Visit 1 and Visit 2, lasting no more than 2 weeks after the first appointment.
Use of validated surveys including the international physical activity questionnaire.
Self-reported by the participant at home between Visit 1 and Visit 2, lasting no more than 2 weeks after the first appointment.
Questionnaire Data - Health
Time Frame: Self-reported by the participant at home between Visit 1 and Visit 2, lasting no more than 2 weeks after the first appointment.
Use of validated surveys including the health eating index.
Self-reported by the participant at home between Visit 1 and Visit 2, lasting no more than 2 weeks after the first appointment.
Questionnaire Data - Ingestive Behaviors
Time Frame: Self-reported by the participant at home between Visit 1 and Visit 2, lasting no more than 2 weeks after the first appointment.
Use of validated surveys including the Yale food addiction scale, Three-Factor Eating questionnaire, Reward-based eating drive, General food craving questionnaire - trait-reduced, Cravings and Want to eat Assessments to food cues.
Self-reported by the participant at home between Visit 1 and Visit 2, lasting no more than 2 weeks after the first appointment.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Differences in Multimodal Brain Signatures
Time Frame: Measured at optional follow up visit at 3 and/or 6 month mark. Scan lasts about 1.5 hour.
Neuroimaging of participants brain via MRI procedure.
Measured at optional follow up visit at 3 and/or 6 month mark. Scan lasts about 1.5 hour.
Differences in Microbiome - Stool
Time Frame: Collected twice by the participant at home before the 3 and/or 6 month follow up appointment, occurring approximately 3 and 6 months after the second (MRI) appointment.
Measurement of 16S RNA, shotgun metagenomics, and metabolomics via stool specimen.
Collected twice by the participant at home before the 3 and/or 6 month follow up appointment, occurring approximately 3 and 6 months after the second (MRI) appointment.
Differences in Microbiome - Blood
Time Frame: Collected once at the 3 and/or 6month follow up appointment, occurring approximately 3 and 6months after the second (MRI) appointment.
Measurement of 16S RNA, shotgun metagenomics, and metabolomics via blood specimen.
Collected once at the 3 and/or 6month follow up appointment, occurring approximately 3 and 6months after the second (MRI) appointment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Arpana Gupta, PhD, The Regents of the University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 24, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB # 20-002326

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

At this time there is no plan to make the de-identified data available for sharing with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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