NCT06787001

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

Exploring the Interplay Between Gut Barrier and Blood-Brain Barrier Integrity, Systemic Inflammation, and Cognitive Function in Obesity

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: University Hospital, Gentofte, Copenhagen · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study is a cross-sectional study including individuals with obesity and lean healthy controls. It is planned to recruit 25 individuals with a BMI above 35 kg/m2 and 25 lean healthy gender- and age-matched individuals with a BMI between 20-25 kg/m2. Given the extensive nature of these examinations, which include the lactulose/sucralose-mannitol test, DCE-MRI, metabolic and cognitive assessments, they will be conducted on three separate study days, in random order, and with fixed time intervals between each study day. The study employs a comprehensive approach to assess gut barrier integrity using the lactulose/sucralose-mannitol test to evaluate barrier permeability and absorptive surface area, complemented by measuring biomarkers related to gut integrity and microbial-immune interaction. Additionally, the study analyses circulating proinflammatory biomarkers and microbial genetic material to understand systemic inflammation and bacterial translocation in obesity. The integrity of the BBB is examined using DCE-MRI to detect alterations in obesity and investigate correlation between BBB permeability and obesity-related neurological conditions. Cognitive functions are assessed through tests that evaluate domains like processing speed and memory and psychopathological tests will evaluate depressive and anxiety symptoms. These tests explore the potential impact of obesity on the central nervous system. Metabolic and physiological measurements, including glucose levels, haemoglobin A1c, and body composition, provide insights into the metabolic effects of obesity and its broader physiological implications.

Conditions

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

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-02-17
• Completion: 2026-02-17
• First posted: 2025-01-22
• Last updated: 2026-02-18

Locations

1 site across 1 country: Denmark