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

NCT05120908 | Completed

• 1 other identifier: IRB # 20-002326
• Study Type: observational
• Target: 266
• Locations: 1 country
• Sites: 1

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.

Conditions

Discrimination, Racial; Social Isolation; Stress

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Multimodal Brain Signatures

  Neuroimaging of participants brain via MRI procedure.

  Measured once at Visit 2. Scan lasts about 1.5 hour.

• Microbiome - Stool

  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

  Measurement of 16S RNA, shotgun metagenomics, and metabolomics via blood specimen.

  Collected once at Day1.

Secondary Outcomes (8)

• Systolic and Diastolic Blood Pressure

  Measured once at Day 1.

• Questionnaire Data - Diet

  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

  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

  Measured once at Day 1.

• Anthropometrics - BMI

  Measured once at Day 1.

Other Outcomes (3)

• Differences in Multimodal Brain Signatures

  Measured at optional follow up visit at 3 and/or 6 month mark. Scan lasts about 1.5 hour.

• Differences in Microbiome - Stool

  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

  Collected once at the 3 and/or 6month follow up appointment, occurring approximately 3 and 6months after the second (MRI) appointment.

Study Arms (2)

Mexican Women

Mexican, premenopausal women ages 18-50.

Filipina Women

Filipina, premenopausal women ages 18-50.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool and plasma are collected.

MeSH Terms

Conditions

Racism; Social Isolation; Obesity; Overweight

Condition Hierarchy (Ancestors)

Prejudice; Social Behavior; Behavior; Social Discrimination; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arpana Gupta, PhD

  The Regents of the University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 16, 2021
• Study Start: August 24, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)