Discrimination and the Brain-Gut-Microbiome (BGM) Axis (NCT05120908) | Clinical Trial Compass
CompletedNot Applicable
Discrimination and the Brain-Gut-Microbiome (BGM) Axis
United States266 participantsStarted 2021-08-24
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Multimodal Brain Signatures
Timeframe: Measured once at Visit 2. Scan lasts about 1.5 hour.
2
Microbiome - Stool
Timeframe: Collected twice by the participant at home between Visit 1 and Visit 2, lasting no more than 2 weeks after the first appointment.