ClinicalTrials.gg
RecruitingNCT07893743ChIPSUpdated Oct 26, 2026

Changes in Intestinal Permeability and Systemic Inflammation Following Fast Food Overfeeding.

An interventional study of Fast-food overfeeding in Obesity & Overweight, sponsored by University Hospital, Gentofte, Copenhagen. Recruiting at 1 site in Denmark. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by University Hospital, Gentofte, Copenhagen · Not applicable, Interventional, and Basic science

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
20 Years to 40 Years
Sex
Male
01

Study 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. 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.

02

Conditions studied

  • Obesity & Overweight

Keywords

  • overfeeding
  • obesity-associated inflammation
  • gut barrier disruption
03

In context

Obesity

6,578 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's planned enrollment of 20 is below the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University Hospital, Gentofte, Copenhagen is the lead sponsor of 161 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Diet intervention.

    Fast-food overfeeding for 14 days.

    Behavioral: Fast-food overfeeding

Interventions

  • BehavioralFast-food overfeeding

    14 days of fast food overfeeding. Number of daily steps limited to 5000.

06

What researchers measure

Primary outcomes

  1. Intestinal permeability

    Assessed using a sugar probe (lactulose/mannitol) test

    Time frame: Day 1, day 15, and after 20 weeks.

07

Study locations

1 of 1 sites recruiting
  • Center for Clinical Metabolic Research, Gentofte Hospital
    Hellerup, 2900, Denmark
    Recruiting
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 10, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07893743
Responsible party
Asger Lund, MD (Associate Professor, University Hospital, Gentofte, Copenhagen) — Principal investigator
First posted
Oct 26, 2026
Start date
Oct 14, 2026 (estimated)
Primary completion
Aug 10, 2027 (estimated)
Completion
Aug 10, 2028 (estimated)
Last update
Oct 26, 2026

Study contacts

Johan Platz, MD
Contact
johan.platz.01@regionh.dk
+4529933611

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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