Obesity & OverweightChIPSNCT07893743
Changes in Intestinal Permeability and Systemic Inflammation Following Fast Food Overfeeding.
A study testing Fast-food overfeeding in people with Obesity & Overweight, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate whether lifestyle factors can alter gut barrier integrity and whether disruptions of the gut barrier can trigger systemic and tissue-specific inflammation. Twenty participants will undergo 14 days of fast-food overfeeding. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Fast-food overfeeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Oct 2026to 10 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal fasting plasma glucose and glycated hemoglobin (HbA1c) <42 mmol/mol
- Body mass index (BMI) between 18.5 and 25 kg/m2
- Hemoglobin >8.3 mmol/l
- Participants must consume a ordinary mixed diet and not follow restrictive or specialized dietary regimens
- Age between 20 and 40 years
- Oral and written informed consent
Who cannot join
- Diabetes
- Known gastrointestinal disease, major or recent abdominal surgery
- First degree relatives with inflammatory bowel disease
- History of BMI > 30.
- Current or history of psychiatric eating disorder
- Regular use of nicotine products in any form
Show all 17Show fewer
- Regular alcohol intake above 18 units per week
- Fasting plasma triacylglycerol indicating dyslipidemia (≥2 mmol/l)
- Nephropathy (estimated glomerular filtration rate (eGFR) <60 ml/min and/or albuminuria with an albumin to creatinine ratio of >30 μg/mg)
- Known liver disease and/or alanine aminotransferase (ALT) >2 × upper reference limits
- Signs of liver fibrosis and/or steatosis evaluated by FibroScan (CAP value >238 dB/m and/or kPa >5.0) and/or FIB-4 score (>1.45)
- Regular use of prescription medication or treatment with systemic antibiotics less than three weeks before the screening visit.
- Use of over-the-counter medication or any dietary supplements known to alter gastrointestinal function, including probiotics, for the period of the study and three weeks prior to screening
- More than two weekly strength and/or aerobic training sessions on a regular basis
- Physical or mental conditions incompatible with magnetic resonance scanning modalities, including implanted metal objects.
- Not willing to agree to use effective contraception during and for 90 days after end of the diet intervention. Acceptable contraception includes condom use and/or ensuring that the female partner(s) uses highly effective contraception.
- Any condition that the investigator feels would interfere with study completion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Center for Clinical Metabolic Research, Gentofte Hospital
Hellerup, 2900
Johan Platz, MD, +4529933611, johan.platz.01@regionh.dk
About this study
The purpose of this study is to investigate whether lifestyle factors can alter gut barrier integrity and whether disruptions of the gut barrier can trigger systemic and tissue-specific inflammation. Twenty participants will undergo 14 days of fast-food overfeeding. Gut barrier function will be assessed before and after the intervention, alongside a wide palette of imaging techniques and biological analyses to characterize inflammatory status.
- Conditions
- Obesity & Overweight
- Being tested
- Fast-food overfeeding
- Keywords
- overfeeding, obesity-associated inflammation, gut barrier disruption
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast-food overfeedingBehavioural
14 days of fast food overfeeding. Number of daily steps limited to 5000.
| Study group | Role | What they receive |
|---|---|---|
| Diet intervention. | Experimental | Fast-food overfeeding for 14 days. Receives: Behavioral: Fast-food overfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal permeability
Assessed using a sugar probe (lactulose/mannitol) test
Measured: Day 1, day 15, and after 20 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start14 Oct 2026 (estimated)
- Primary completion10 Aug 2027 (estimated)
- Study completion10 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Asger Lund, MD, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893743
- Sponsor's protocol ID
- H-26038687
- Acronym
- ChIPS
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol is available on ClinicalTrials.org. De-identified individual participant data will be available from publication of this article indefinitely upon request to the corresponding author from researchers who provide a methodologically sound proposal. To gain access to the data, the researchers will need to sign a data sharing agreement and/or collaborative agreement.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Intestinal Permeability and Systemic Inflammation Following Fast Food Overfeeding.
- ClinicalTrials.gov ID
- NCT07893743
- Acronym / sponsor ID
- ChIPS / H-26038687
- Conditions
- Obesity & Overweight
- Keywords
- overfeeding, obesity-associated inflammation, gut barrier disruption
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 14 Oct 2026 (estimated)
- Primary completion
- 10 Aug 2027 (estimated)
- Study completion
- 10 Aug 2028 (estimated)
- First posted
- 26 Oct 2026 (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 purpose of this study is to investigate whether lifestyle factors can alter gut barrier integrity and whether disruptions of the gut barrier can trigger systemic and tissue-specific inflammation. Twenty participants will undergo 14 days of fast-food overfeeding. Gut barrier function will be assessed before and after the intervention, alongside a wide palette of imaging techniques and biological analyses to characterize inflammatory status.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diet intervention. | Experimental | Behavioral: Fast-food overfeedingFast-food overfeeding for 14 days. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Normal fasting plasma glucose and glycated hemoglobin (HbA1c) <42 mmol/mol
- Body mass index (BMI) between 18.5 and 25 kg/m2
- Hemoglobin >8.3 mmol/l
- Participants must consume a ordinary mixed diet and not follow restrictive or specialized dietary regimens
- Age between 20 and 40 years
Key exclusion criteria (17 listed)
- Diabetes
- Known gastrointestinal disease, major or recent abdominal surgery
- First degree relatives with inflammatory bowel disease
- History of BMI > 30.
- Current or history of psychiatric eating disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast-food overfeeding14 days of fast food overfeeding. Number of daily steps limited to 5000. | Behavioural | Diet intervention. |
Primary outcome
Intestinal permeability
Time frame: Day 1, day 15, and after 20 weeks.
Assessed using a sugar probe (lactulose/mannitol) test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. The study protocol is available on ClinicalTrials.org. De-identified individual participant data will be available from publication of this article indefinitely upon request to the corresponding author from researchers who provide a methodologically sound proposal. To gain access to the data, the researchers will need to sign a data sharing agreement and/or collaborative agreement.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast-food overfeeding in people with Obesity & Overweight, 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 6 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 26 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johan Platz, MD (+4529933611, johan.platz.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal permeability (time frame: Day 1, day 15, and after 20 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.