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

NCT06787001 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-02-18

No results posted yet for this study

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.

Conditions

  • Obesity (Disorder)
  • Systemic Inflammation Markers
  • Intestinal Barrier Dysfunction
  • Blood Brain Barrier
  • Neurodegenerative Disease

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • University Hospital, Gentofte, Copenhagen

    lead OTHER

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-02-17
Completion
2026-02-17

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06787001 on ClinicalTrials.gov