Status:
RECRUITING
Why Calories Are Not the Same - a Gut Explanation?
Lead Sponsor:
University of Copenhagen
Collaborating Sponsors:
Wageningen University and Research
Conditions:
Diet, Healthy
Breath Analysis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The aim of this study is to understand how the gut microbiome influences how much dietary energy humans excrete via feces. This study is based on the hypothesis that levels of methane in exhaled breat...
Detailed Description
The trial is a cross-over trial including two controlled isocaloric dietary interventions of three days duration. The two diets are isocaloric but with different contents of fiber, resistant starch, a...
Eligibility Criteria
Inclusion
- 18-65 years old
- BMI:18.5-29.9 kg/m2
- Self-reported regular defecations defined as at least every second day
- Willing to collect urine and stool samples at home and able to temporarily store them in their own freezer in a provided container
- Willing to exclusively eat the food provided
- Owning a smartphone (iOS 11.0 and onwards, or Android 5.0 and onwards) with access to the internet
- Speak and understand Danish or English
Exclusion
- Current pregnancy or lactation
- Following a specific dietary program or diet (e.g., vegetarian, vegan, gluten-free) or unable to consume the food provided
- Diagnosis of small intestinal bacterial overgrowth (SIBO), inflammatory bowel diseases (IBD), gastrointestinal obstruction, or ischemic colitis
- Diagnosed chronic constipation
- Regular use of diarrhea inhibitors or laxatives
- Any chronic disease that can affect the outcomes of the study
- Use of medications potentially altering gastric pH (proton pump inhibitors, histamine receptor antagonists, antacids)
- Use of medications potentially altering the gastro-intestinal motility (prokinetics, antiemetic agents, anticholinergic agents, narcotic analgesics, nonsteroidal anti-inflammatory drugs, peroral glucocorticoids, and GLP-1 related medications such as semaglutide and liraglutide)
- Use of antibiotics, or any medication that can affect any outcomes of the study, within the previous three months
- Concurrent participation in another trial
- Any condition that makes the project responsible and/or the clinical responsible doubt the feasibility of the volunteer's participation
Key Trial Info
Start Date :
May 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06932666
Start Date
May 15 2025
End Date
December 31 2026
Last Update
December 26 2025
Active Locations (1)
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1
University of Copenhagen, Department of Nutrition, Exercise and Sports
Frederiksberg, Capital Region, Denmark, 1958