NCT07893743Recruiting
Changes in Intestinal Permeability and Systemic Inflammation Following Fast Food Overfeeding.
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 28 Sept 2026
- Start date
- 14 Oct 2026
- Primary completion date
- 10 Aug 2027
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Diseases
- Obesity
- NCT number
- NCT07893743
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 14 Oct 2026 to the primary completion date, 10 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
- Physical or mental conditions incompatible with magnetic resonance scanning modalities, including implanted metal objects.
- Any condition that the investigator feels would interfere with study completion
Lab values
- 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
Other
- Regular use of nicotine products in any form
- Regular alcohol intake above 18 units per week
- 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)
- More than two weekly strength and/or aerobic training sessions on a regular basis
- 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.
Who the study is looking for
- 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
Age in the registry: 20 years to 40 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for Clinical Metabolic Research, Gentofte Hospital Coordinator of this site? Confirm its status | Hellerup | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.