CompletedNot Applicable

Understanding How Gut and Brain Barriers Are Linked to Inflammation in Obesity

Denmark50 participantsStarted 2025-04-01

Plain-language summary

The goal of this observational study is to understand how obesity affects the function of the gut and blood-brain barriers in adults. These barriers protect the body and brain from harmful substances, and changes in their function may lead to inflammation and increased risk of chronic diseases. The study will include 25 participants with obesity (BMI over 35) and 25 healthy participants (BMI 20-25) matched by age and gender. The main questions it aims to answer are: * How does obesity affect the blood-brain barrier and its connection to cognitive and psychopathological status? * Does increased gut permeability lead to higher inflammation levels? * Does obesity increase the permeability of the gut barrier? Researchers will compare results from participants with obesity to healthy participants to determine how obesity impacts barrier function, inflammation, and overall health. Participants will: Attend three visits over several days, including: * Screening visit: A health examination with weight, height, blood pressure, blood tests, and a scan to assess body fat distribution. * Visit 1: Provide a stool sample, drink a sugar solution to assess gut permeability, collect urine samples, and take cognitive as well as psychopathological tests. * Visit 2: Undergo an MRI scan to assess the blood-brain barrier and its function. The study aims to identify how obesity-related changes in these barriers contribute to health risks.

Who can participate

Age range

40 Years – 70 Years

Sex

ALL

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 for individuals living with obesity * BMI \> 35 kg/m2, bioimpedance-assessed body fat \> 30% (men) or \> 40% (women), and hip/waist-ratio \> 0.85 * Age ≥40 and ≦70 years * Sterilised or postmenopausal women (\> 12 months amenorrhoea or females ≥ 60 years of age) or women who are sexually abstinent during the entire study period or are practicing non-hormonal contraception (no contraceptive pill, no hormonal intrauterine device) during the entire study period * Able to understand written participant information and give signed informed consent. Inclusion criteria for lean healthy controls * BMI 20-25 kg/m2, bioimpedance-assessed body fat \< 30% (men) or \< 40% (women), and hip/waist-ratio \< 0.85 * Age ≥40 and ≦70 years * Sterilised or postmenopausal women (\> 12 months amenorrhoea or females ≥ 60 years of age) or women who are sexually abstinent during the entire study period or are practicing non-hormonal contraception (no contraceptive pill, no hormonal intrauterine device) during the entire study period Exclusion Criteria: * Diagnosis of diabetes mellitus type 1 or type 2. * Inflammatory gastrointestinal conditions such as Crohn's disease, ulcerative colitis, clinically significant food allergies, candidiasis, etc. * Previous bariatric surgery, or surgeries involving the removal of intestinal tissue * The use of weight loss-inducing medication such as GLP-1 receptor agonists, bupropion/naltrexone, and orlistat within 90 days prior to screening * Pla…

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

BBB permeability

Timeframe: 25 minutes post contrast administration

Trial details

NCT IDNCT06787001

SponsorUniversity Hospital, Gentofte, Copenhagen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-02-17

View on ClinicalTrials.gov More Obesity (Disorder) trials