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

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ClinicalTrials.gov Identifier: NCT05120908
Recruitment Status : Recruiting
First Posted : November 16, 2021
Last Update Posted : November 23, 2021
Sponsor:
Information provided by (Responsible Party):
Arpana Gupta, University of California, Los Angeles

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.

Condition or disease
Discrimination, Racial Social Isolation Stress

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Study Type : Observational
Estimated Enrollment : 270 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Social Isolation and Discrimination as Stressors Influencing BGM Alterations
Actual Study Start Date : August 24, 2021
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2027

Group/Cohort
Mexican Women
Mexican, premenopausal women ages 18-50.
Filipina Women
Filipina, premenopausal women ages 18-50.



Primary Outcome Measures :
  1. Multimodal Brain Signatures [ Time Frame: Measured once at Visit 2. Scan lasts about 1.5 hour. ]
    Neuroimaging of participants brain via MRI procedure.

  2. 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.

  3. Microbiome - Blood [ Time Frame: Collected once at Day1. ]
    Measurement of 16S RNA, shotgun metagenomics, and metabolomics via blood specimen.


Secondary Outcome Measures :
  1. Systolic and Diastolic Blood Pressure [ Time Frame: Measured once at Day 1. ]
    Measurement of the pressure of circulating blood at rest.

  2. 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.

  3. 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.

  4. Anthropometrics - waist & hip circumference [ Time Frame: Measured once at Day 1. ]
    Measurement of waist and hip circumference(cm).

  5. Anthropometrics - BMI [ Time Frame: Measured once at Day 1. ]
    Measurement of height(in) and weight(lbs), used to calculate BMI.

  6. 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.

  7. 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.

  8. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.


Biospecimen Retention:   Samples Without DNA
Stool and plasma are collected.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants recruited from the greater Los Angeles Mexican & Filipina female population.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05120908


Contacts
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Contact: Allison Vaughan, MPH 3108257206 allisonvaughan@mednet.ucla.edu

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Allison Vaughan, MPH    310-825-7206    allisonvaughan@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Arpana Gupta, PhD The Regents of the University of California, Los Angeles
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Responsible Party: Arpana Gupta, Associate Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT05120908    
Other Study ID Numbers: IRB # 20-002326
First Posted: November 16, 2021    Key Record Dates
Last Update Posted: November 23, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: At this time there is no plan to make the de-identified data available for sharing with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arpana Gupta, University of California, Los Angeles:
Obese
Mexican Women
Filipina Women
Overweight
Brain-Gut Microbiome
MRI
Metabolome