Gut barrier and inflammation after fast-food overfeeding in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Twenty adults (20–40 years old) without diabetes or major GI disease will undergo 14 days of fast-food overfeeding. Researchers will measure gut barrier integrity before and after the intervention, along with imaging and biological analyses to characterize inflammatory status. The goal is to understand how lifestyle-related food intake might influence gut permeability and systemic inflammation. Safety will be monitored, and participants must meet specific health and dietary criteria to participate.

Why it matters

Who can join: the full rules

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:

* 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

Where it's running

• Center for Clinical Metabolic Research, Gentofte Hospital
  Hellerup, Denmark Recruiting

Study contacts

• Study coordinator: Johan Platz, MD
• Email: johan.platz.01@regionh.dk
• Phone: +4529933611

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.