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

Social Isolation and Discrimination as Stressors Influencing BGM Alterations

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05120908
Enrollment
266
Registered
2021-11-16
Start date
2021-08-24
Completion date
2024-12-31
Last updated
2025-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Discrimination, Racial, Social Isolation, Stress

Keywords

Obese, Mexican Women, Filipina Women, Overweight, Brain-Gut Microbiome, MRI, Metabolome

Brief 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. 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.

Interventions

None listed

Sponsors

University of California, Los Angeles
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Microbiome - BloodCollected once at Day1.Measurement of 16S RNA, shotgun metagenomics, and metabolomics via blood specimen.
Microbiome - StoolCollected 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.
Multimodal Brain SignaturesMeasured once at Visit 2. Scan lasts about 1.5 hour.Neuroimaging of participants brain via MRI procedure.

Secondary

MeasureTime frameDescription
Questionnaire Data - StressorsSelf-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.
Anthropometrics - waist & hip circumferenceMeasured once at Day 1.Measurement of waist and hip circumference(cm).
Questionnaire Data - Physical ActivitySelf-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.
Questionnaire Data - HealthSelf-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.
Questionnaire Data - Ingestive BehaviorsSelf-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.
Anthropometrics - BMIMeasured once at Day 1.Measurement of height(in) and weight(lbs), used to calculate BMI.
Systolic and Diastolic Blood PressureMeasured once at Day 1.Measurement of the pressure of circulating blood at rest.
Questionnaire Data - DietSelf-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.

Other

MeasureTime frameDescription
Differences in Multimodal Brain SignaturesMeasured 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.
Differences in Microbiome - BloodCollected 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.
Differences in Microbiome - StoolCollected 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026