Trials Sponsors Conditions Drugs Pricing

Conditions

Obesity & Overweight

Keywords

overfeedingobesity-associated inflammationgut barrier disruption

Outcome Measures

Primary Outcomes (1)

Intestinal permeability
Assessed using a sugar probe (lactulose/mannitol) test
Day 1, day 15, and after 20 weeks.

Study Arms (1)

Diet intervention.

EXPERIMENTAL

Fast-food overfeeding for 14 days.

Behavioral: Fast-food overfeeding

Interventions

Fast-food overfeedingBehavioral

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

Diet intervention.

Eligibility Criteria

Age20 Years - 40 Years

Sexmale(Gender-based eligibility)

Gender Eligibility DetailsIntestinal permeability is however affected by the menstrual cycle and use of oral contraceptives. To include women the study should either 1) prolong the diet intervention for all participants to the length of a full menstrual cycle or 2) synchronize study days with the female participants' menstrual cycle. Option 1) was considered too disadvantageous for participants in terms of weight gain and overall discomfort, and option 2) was not feasible due to MRS/MRE and colonoscopies only being available on specific weekdays. Furthermore, an exploratory outcome is the causal effects of a hypercaloric fast food diet intervention on semen concentration, motility and DNA fragmentation. Including only men will allow a reasonable sample size for these analyses.

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Sponsors & Collaborators

University of Copenhagen
Othercollaborator
University Hospital, Gentofte, Copenhagen
Otherlead

Study Sites (1)

Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, 2900, Denmark

RECRUITING

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

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Johan Platz, MD

CONTACT

+4529933611 johan.platz.01@regionh.dk

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: BASIC SCIENCE
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Professor

Study Record Dates

First Submitted

September 28, 2026

First Posted

October 26, 2026

Study Start

October 14, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

August 10, 2027

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Diet intervention.

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Diet intervention.

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations