Discrimination, RacialNCT05120908
Discrimination and the Brain-Gut-Microbiome (BGM) Axis
An observational study of Discrimination, Racial and Social Isolation, run by University of California, Los Angeles at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Discrimination, Racial, Social Isolation, Stress
- How many people
- 266 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Participants recruited from the greater Los Angeles Mexican \& Filipina female population.
Who may be able to join
- Premenopausal females
- Ages 18-50
- Mexican or Filipino ancestry
- BMI 19-40
- Fluent in English
- Right-handed
Who cannot join
- 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
Show all 36Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: 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.
- Conditions
- Discrimination, Racial, Social Isolation, Stress
- Keywords
- Obese, Mexican Women, Filipina Women, Overweight, Brain-Gut Microbiome, MRI, Metabolome
- Medical subject headings
- Racism, Social Isolation, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mexican Women | Mexican, premenopausal women ages 18-50. | |
| Filipina Women | Filipina, premenopausal women ages 18-50. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multimodal Brain Signatures
Neuroimaging of participants brain via MRI procedure.
Measured: Measured once at Visit 2. Scan lasts about 1.5 hour.
Microbiome - Stool
Measurement of 16S RNA, shotgun metagenomics, and metabolomics via stool specimen.
Measured: 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
Measurement of 16S RNA, shotgun metagenomics, and metabolomics via blood specimen.
Measured: Collected once at Day1.
Secondary outcomes (8)
Systolic and Diastolic Blood Pressure
Measurement of the pressure of circulating blood at rest.
Measured: Measured once at Day 1.
Questionnaire Data - Diet
Use of validated surveys including the Food Frequency questionnaire, Food choice questionnaire.
Measured: 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
Use of validated surveys including, Social isolation scale, Social network engagement, Family cohesion, Acculturative stress, Perceived stress scale, Everyday Discrimination, and major discrimination.
Measured: 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
Measurement of waist and hip circumference(cm).
Measured: Measured once at Day 1.
Anthropometrics - BMI
Measurement of height(in) and weight(lbs), used to calculate BMI.
Measured: Measured once at Day 1.
Questionnaire Data - Physical Activity
Use of validated surveys including the international physical activity questionnaire.
Measured: 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
Use of validated surveys including the health eating index.
Measured: 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
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.
Measured: Self-reported by the participant at home between Visit 1 and Visit 2, lasting no more than 2 weeks after the first appointment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start24 Aug 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discrimination, RacialStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arpana Church, University of California, Los Angeles
- Investigators
- Arpana Gupta, PhD, Principal investigator, The Regents of the University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120908
- Sponsor's protocol ID
- IRB # 20-002326
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2021
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time there is no plan to make the de-identified data available for sharing with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Isolation and Discrimination as Stressors Influencing BGM Alterations
- ClinicalTrials.gov ID
- NCT05120908
- Acronym / sponsor ID
- IRB # 20-002326
- Conditions
- Discrimination, Racial, Social Isolation, Stress
- Keywords
- Obese, Mexican Women, Filipina Women, Overweight, Brain-Gut Microbiome, MRI, Metabolome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mexican Women | – | –Mexican, premenopausal women ages 18-50. |
| Filipina Women | – | –Filipina, premenopausal women ages 18-50. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants recruited from the greater Los Angeles Mexican \& Filipina female population.
Key inclusion criteria (6 listed)
- Premenopausal females
- Ages 18-50
- Mexican or Filipino ancestry
- BMI 19-40
- Fluent in English
Key exclusion criteria (36 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Multimodal Brain Signatures
Time frame: Measured once at Visit 2. Scan lasts about 1.5 hour.
Neuroimaging of participants brain via MRI procedure.
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.
Microbiome - Blood
Time frame: Collected once at Day1.
Measurement of 16S RNA, shotgun metagenomics, and metabolomics via blood specimen.
8 secondary outcomes
Systolic and Diastolic Blood Pressure
Time frame: 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.
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.
Anthropometrics - waist & hip circumference
Time frame: Measured once at Day 1.
Anthropometrics - BMI
Time frame: 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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No. At this time there is no plan to make the de-identified data available for sharing with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arpana Gupta, PhD principal investigator
The Regents of the University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Discrimination, Racial and Social Isolation, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multimodal Brain Signatures (time frame: Measured once at Visit 2. Scan lasts about 1.5 hour.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.