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Search / Trial NCT06932666

Why Calories Are Not the Same - a Gut Explanation?

Launched by UNIVERSITY OF COPENHAGEN · Apr 10, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Fecal Energy Metabolizable Energy Breath Methane Gut Microbiome Metabolomics Dietary Fiber Resistant Starch Food Particle Size

ClinConnect Summary

This clinical trial, titled "Why Calories Are Not the Same - a Gut Explanation?", is exploring how the bacteria in our gut (known as the gut microbiome) affects how much energy we get from our food and how much of it we excrete. Researchers believe that the levels of methane in our breath can indicate different types of gut bacteria, which might influence how much energy we lose through our stool. Participants will follow two specific diets that have the same number of calories but differ in fiber and other components. This will help the researchers understand how these different diets impact our gut bacteria and energy absorption.

To join this study, participants should be between 18 and 65 years old, have a body mass index (BMI) between 18.5 and 29.9, and have regular bowel movements at least every other day. They must also be willing to collect and store urine and stool samples at home and eat only the provided foods. Additionally, participants should speak and understand either Danish or English and have access to a smartphone with internet. It's important to note that some individuals, such as those who are pregnant, have certain medical conditions, or are taking specific medications, may not be eligible to participate. Overall, this study is a chance to contribute to our understanding of diet and gut health, which could lead to better nutrition advice in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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

About University Of Copenhagen

The University of Copenhagen, a leading research institution in Denmark, is dedicated to advancing medical knowledge and improving patient outcomes through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university leverages its expertise in various fields, including health sciences, pharmacology, and biotechnology, to design and conduct rigorous clinical studies. Committed to ethical standards and scientific integrity, the University of Copenhagen aims to contribute significantly to the global medical community by facilitating groundbreaking research that addresses pressing healthcare challenges.

Locations

Frederiksberg C, Capital Region, Denmark

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported