- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05120908
Discrimination and the Brain-Gut-Microbiome (BGM) Axis
January 9, 2023 updated by: Arpana Gupta, 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
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
270
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
- Name: Allison Vaughan, MPH
- Phone Number: 3108257206
- Email: allisonvaughan@mednet.ucla.edu
Study Locations
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California
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Los Angeles, California, United States, 90095
- Recruiting
- University of California, Los Angeles
-
Contact:
- Allison Vaughan, MPH
- Phone Number: 310-825-7206
- Email: allisonvaughan@mednet.ucla.edu
-
-
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
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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
- Full Mexican or Filipino ancestry only
- 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 |
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Mexican Women
Mexican, premenopausal women ages 18-50.
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Filipina Women
Filipina, premenopausal women ages 18-50.
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What is the study measuring?
Primary Outcome Measures
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.
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Measurement of 16S RNA, shotgun metagenomics, and metabolomics via stool specimen.
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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
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.
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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.
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Use of validated surveys including the Food Frequency questionnaire, Food choice questionnaire.
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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.
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Use of validated surveys including, Social isolation scale, Social network engagement, Family cohesion, Acculturative stress, Perceived stress scale, Everyday Discrimination, and major discrimination.
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Self-reported by the participant at home between Visit 1 and Visit 2, lasting no more than 2 weeks after the first appointment.
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Anthropometrics - waist & hip circumference
Time Frame: Measured once at Day 1.
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Measurement of waist and hip circumference(cm).
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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.
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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.
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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
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.
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)
August 24, 2021
Primary Completion (Anticipated)
December 1, 2024
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
October 21, 2021
First Submitted That Met QC Criteria
November 2, 2021
First Posted (Actual)
November 16, 2021
Study Record Updates
Last Update Posted (Estimate)
January 10, 2023
Last Update Submitted That Met QC Criteria
January 9, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Other Study ID 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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