Obesity (Disorder)GUTBBBNCT06787001

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

An observational study of Obesity (Disorder) and Systemic Inflammation Markers, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Obesity (Disorder), Systemic Inflammation Markers, Intestinal Barrier Dysfunction
How many people: 50 participants
Where: 1 siteDenmark
Study dates: 1 Apr 2025to 17 Feb 2026
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Older individuals with and without obesity

Who may be able to join

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.
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

Who cannot join

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
Planned elective surgery during the study period with the exception of dermatosurgical, ENT (ear, nose, throat) or dental procedures not requiring general anaesthesia and/or perioperative antibiotic treatment
Chronic systemic inflammatory diseases (e.g. rheumatoid arthritis) and other conditions significantly affecting inflammation status or immunoregulation (severe allergies, status post transplantation etc.)

Show all 24Show fewer

History of sleep disorders
Chronic infectious diseases such as hepatitis, HIV etc.
Use of proton pump inhibitors, metformin, anti-biotic, lipid-lowering statins, laxatives, antihistamines, paracetamol, aspirin, statins, tricyclic antidepressants, selective serotonin reuptake inhibitor antidepressants and any other medications correlated to changes in faecal microbiome diversity for the period of the study and within 20 days prior to screening
Active use of nicotine products, including but not limited to cigarettes, vapes, or any other form of nicotine consumption.
Abuse of alcohol and/or drugs, or any other co-existing conditions that will make the individual unsuitable to participate in the study, as deemed by the investigators
Pregnancy or desire to become pregnant during the study period
Breastfeeding
Any concomitant disease or treatment that, at the discretion of the investigators, might jeopardise the participant's safety during the study
Mental incapacity or language barriers that preclude adequate understanding or cooperation, or unwillingness to comply with study requirements
Body weight above the MRI scanner's maximum capacity of 140 kg or claustrophobia at a level, which makes MRI scans impossible
Severe kidney disease with increased serum creatinine and low estimated glomerular filtration rate (GFR) (<60ml/min/1.73m2)
Magnetic foreign objects in the body (e.g. pacemaker, metal implants from operation, etc.)
Adherence to a restrictive diet (e.g. ketogenic diet, vegan diet, raw diet, low FODMAP diet, and paleo diet) which is significantly correlated to changes in faecal microbiome diversity 7.2.3. Criteria for discontinuation in the study
Withdrawal of informed consent
Pregnancy
Any safety consideration as assessed by the investigators
Any exclusion criterion developing or being diagnosed during the course of the study
Non-compliance with the study protocol as deemed by the investigators

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Herlev Gentofte Hospital
Hellerup, 2900

Other trials in Denmark

About this study

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

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.

Read the 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
Keywords: intestinal barrier function, blood brain barrier function, microbiome, systemic inflammation, bacterial translocation
Medical subject headings: Obesity, Neurodegenerative Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06787001
Study group	Role	What they receive
Individuals living with obesity		BMI > 35 kg/m2, bioimpedance-assessed body fat > 30% (men) or > 40% (women), and hip/waist-ratio > 0.85
Individuals with lean bodies		BMI 20-25 kg/m2, bioimpedance-assessed body fat < 30% (men) or < 40% (women), and hip/waist-ratio < 0.85

What is being measured

The primary outcome is the main question the study is designed to answer.

BBB permeability
Differences in BBB permeability using Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) between individuals with and without obesity
Measured: 25 minutes post contrast administration

Secondary outcomes (26)

Correlation between BBB permeability and gut barrier permeability
Ki values from DCE-MRI and Lactulose/Mannitol ratio from Lactulose/Sucralose-Mannitol test.
Measured: 25 minutes post contrast administration and 0-5h Lactulose/Mannitol ratio
Correlation between BBB permeability and gut barrier permeability
Ki values from DCE-MRI and Lactulose/Mannitol ratio from Lactulose/Sucralose-Mannitol test.
Measured: 25 minutes post contrast administration and 5-24h Lactulose/Mannitol ratio
Correlation between BBB permeability and gut barrier permeability
Ki values from DCE-MRI and quantities of plasma Zonulin
Measured: 25 minutes post contrast administration and baseline (fasting) Zonulin
Correlation between BBB permeability and gut barrier permeability
Ki values from DCE-MRI and quantities of plasma Citrulline
Measured: 25 minutes post contrast administration and baseline (fasting) Citrulline
Correlation between BBB permeability and gut barrier permeability
Ki values from DCE-MRI and quantities of plasma Regenerating islet-derived protein 3-alpha
Measured: 25 minutes post contrast administration and baseline (fasting) Regenerating islet-derived protein 3-alpha
Correlation between BBB permeability and gut barrier permeability
Ki values from DCE-MRI and quantities of plasma Lipopolysaccharide binding protein
Measured: 25 minutes post contrast administration and baseline (fasting) LBP
Correlation between BBB permeability and gut barrier permeability
Ki values from DCE-MRI and quantities of plasma soluble cluster of differentiation 14
Measured: 25 minutes post contrast administration and baseline (fasting) sCD14
Correlation between BBB permeability and gut barrier permeability
Ki values from DCE-MRI and full blood bacterial DNA
Measured: 25 minutes post contrast administration and postprandial AUC of full blood bacterial DNA
Correlation between BBB permeability and markers of neuronal damage
Ki values from DCE-MRI and quantities of plasma Amyloid beta
Measured: 25 minutes post contrast administration and baseline (fasting) Amyloid beta
Correlation between BBB permeability and markers of neuronal damage
Ki values from DCE-MRI and quantities of plasma P-Tau
Measured: 25 minutes post contrast administration and baseline (fasting) P-Tau
Correlation between BBB permeability and markers of neuronal damage
Ki values from DCE-MRI and quantities of plasma NfL
Measured: 25 minutes post contrast administration and baseline (fasting) NfL
Correlation between BBB permeability and markers of neuronal damage
Ki values from DCE-MRI and quantities of plasma GFAP
Measured: 25 minutes post contrast administration and baseline (fasting) GFAP
Correlation between BBB permeability and markers of neuronal damage
Ki values from DCE-MRI and quantities of plasma Alfa-Synuclein
Measured: 25 minutes post contrast administration and baseline (fasting) Alfa-Synuclein
Correlation between BBB permeability and systemic inflammation
Ki values from DCE-MRI and quantities of plasma High sensitivity CRP
Measured: 25 minutes post contrast administration and baseline (fasting) HS CRP
Correlation between BBB permeability and systemic inflammation
Ki values from DCE-MRI and quantities of plasma TNF alfa
Measured: 25 minutes post contrast administration and baseline (fasting) TNF alfa
Correlation between BBB permeability and systemic inflammation
Ki values from DCE-MRI and quantities of plasma IL 1 beta
Measured: 25 minutes post contrast administration and baseline (fasting) IL 1 beta
Correlation between BBB permeability and metabolic markers
Ki values from DCE-MRI and Body mass index
Measured: 25 minutes post contrast administration and body mass index
Correlation between BBB permeability and metabolic markers
Ki values from DCE-MRI and bioimpedance-assessed body fat
Measured: 25 minutes post contrast administration and bioimpedance-assessed body fat
Correlation between BBB permeability and metabolic markers
Ki values from DCE-MRI and plasma Glucose
Measured: 25 minutes post contrast administration and baseline (fasting) Glucose
Correlation between BBB permeability and metabolic markers
Ki values from DCE-MRI and plasma HbA1c
Measured: 25 minutes post contrast administration and baseline (fasting) HbA1c
Correlation between BBB permeability and metabolic markers
Ki values from DCE-MRI and plasma Insulin
Measured: 25 minutes post contrast administration and baseline (fasting) Insulin
Correlation between BBB permeability and metabolic markers
Ki values from DCE-MRI and plasma HDL cholesterol
Measured: 25 minutes post contrast administration and baseline (fasting) HDL cholesterol
Correlation between BBB permeability and metabolic markers
Ki values from DCE-MRI and plasma Triglycerides
Measured: 25 minutes post contrast administration and baseline (fasting) Triglycerides
Correlation between BBB permeability and metabolic markers
Ki values from DCE-MRI and plasma LDL cholesterol
Measured: 25 minutes post contrast administration and baseline (fasting) LDL cholesterol
Correlation between BBB permeability and metabolic markers
Ki values from DCE-MRI and plasma VLDL cholesterol
Measured: 25 minutes post contrast administration and baseline (fasting) VLDL cholesterol
Correlation between BBB permeability and metabolic markers
Ki values from DCE-MRI and plasma ALT
Measured: 25 minutes post contrast administration and baseline (fasting) ALT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 202517 Feb 2026

First posted22 Jan 2025
Study start1 Apr 2025
Primary completion17 Feb 2026
Study completion17 Feb 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Obesity (Disorder)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Cross-sectional
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06787001
Sponsor's protocol ID: GUTBBB
Acronym: GUTBBB
Status last verified: Feb 2026
First submitted: 9 Jan 2025
Last updated: 18 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exploring the Interplay Between Gut Barrier and Blood-Brain Barrier Integrity, Systemic Inflammation, and Cognitive Function in Obesity
ClinicalTrials.gov ID: NCT06787001
Acronym / sponsor ID: GUTBBB / GUTBBB
Conditions: Obesity (Disorder), Systemic Inflammation Markers, Intestinal Barrier Dysfunction, Blood Brain Barrier, Neurodegenerative Disease
Keywords: intestinal barrier function, blood brain barrier function, microbiome, systemic inflammation, bacterial translocation
Study type: Observational
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University Hospital, Gentofte, CopenhagenUniversity, hospital or other
Collaborators: University of Copenhagen
Study start: 1 Apr 2025 (actual)
Primary completion: 17 Feb 2026 (actual)
Study completion: 17 Feb 2026 (actual)
First posted: 22 Jan 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
Individuals living with obesity	–	–BMI > 35 kg/m2, bioimpedance-assessed body fat > 30% (men) or > 40% (women), and hip/waist-ratio > 0.85
Individuals with lean bodies	–	–BMI 20-25 kg/m2, bioimpedance-assessed body fat < 30% (men) or < 40% (women), and hip/waist-ratio < 0.85

Who may qualify

Ages: 40 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Older individuals with and without obesity

Key inclusion criteria (7 listed)

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.
BMI 20-25 kg/m2, bioimpedance-assessed body fat < 30% (men) or < 40% (women), and hip/waist-ratio < 0.85

Key exclusion criteria (24 listed)

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
Planned elective surgery during the study period with the exception of dermatosurgical, ENT (ear, nose, throat) or dental procedures not requiring general anaesthesia and/or perioperative antibiotic treatment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

BBB permeability
Time frame: 25 minutes post contrast administration
Differences in BBB permeability using Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) between individuals with and without obesity

26 secondary outcomes

Correlation between BBB permeability and gut barrier permeability
Time frame: 25 minutes post contrast administration and 0-5h Lactulose/Mannitol ratio
Correlation between BBB permeability and gut barrier permeability
Time frame: 25 minutes post contrast administration and 5-24h Lactulose/Mannitol ratio
Correlation between BBB permeability and gut barrier permeability
Time frame: 25 minutes post contrast administration and baseline (fasting) Zonulin
Correlation between BBB permeability and gut barrier permeability
Time frame: 25 minutes post contrast administration and baseline (fasting) Citrulline
Correlation between BBB permeability and gut barrier permeability
Time frame: 25 minutes post contrast administration and baseline (fasting) Regenerating islet-derived protein 3-alpha
Correlation between BBB permeability and gut barrier permeability
Time frame: 25 minutes post contrast administration and baseline (fasting) LBP
Correlation between BBB permeability and gut barrier permeability
Time frame: 25 minutes post contrast administration and baseline (fasting) sCD14
Correlation between BBB permeability and gut barrier permeability
Time frame: 25 minutes post contrast administration and postprandial AUC of full blood bacterial DNA
Correlation between BBB permeability and markers of neuronal damage
Time frame: 25 minutes post contrast administration and baseline (fasting) Amyloid beta
Correlation between BBB permeability and markers of neuronal damage
Time frame: 25 minutes post contrast administration and baseline (fasting) P-Tau
Correlation between BBB permeability and markers of neuronal damage
Time frame: 25 minutes post contrast administration and baseline (fasting) NfL
Correlation between BBB permeability and markers of neuronal damage
Time frame: 25 minutes post contrast administration and baseline (fasting) GFAP
Correlation between BBB permeability and markers of neuronal damage
Time frame: 25 minutes post contrast administration and baseline (fasting) Alfa-Synuclein
Correlation between BBB permeability and systemic inflammation
Time frame: 25 minutes post contrast administration and baseline (fasting) HS CRP
Correlation between BBB permeability and systemic inflammation
Time frame: 25 minutes post contrast administration and baseline (fasting) TNF alfa
Correlation between BBB permeability and systemic inflammation
Time frame: 25 minutes post contrast administration and baseline (fasting) IL 1 beta
Correlation between BBB permeability and metabolic markers
Time frame: 25 minutes post contrast administration and body mass index
Correlation between BBB permeability and metabolic markers
Time frame: 25 minutes post contrast administration and bioimpedance-assessed body fat
Correlation between BBB permeability and metabolic markers
Time frame: 25 minutes post contrast administration and baseline (fasting) Glucose
Correlation between BBB permeability and metabolic markers
Time frame: 25 minutes post contrast administration and baseline (fasting) HbA1c
Correlation between BBB permeability and metabolic markers
Time frame: 25 minutes post contrast administration and baseline (fasting) Insulin
Correlation between BBB permeability and metabolic markers
Time frame: 25 minutes post contrast administration and baseline (fasting) HDL cholesterol
Correlation between BBB permeability and metabolic markers
Time frame: 25 minutes post contrast administration and baseline (fasting) Triglycerides
Correlation between BBB permeability and metabolic markers
Time frame: 25 minutes post contrast administration and baseline (fasting) LDL cholesterol
Correlation between BBB permeability and metabolic markers
Time frame: 25 minutes post contrast administration and baseline (fasting) VLDL cholesterol
Correlation between BBB permeability and metabolic markers
Time frame: 25 minutes post contrast administration and baseline (fasting) ALT

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity (Disorder) and Systemic Inflammation Markers, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BBB permeability (time frame: 25 minutes post contrast administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06787001.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.