Status:
COMPLETED
Effects of Changing Intestinal Transit Time on Gut Microbial Composition and Metabolism
Lead Sponsor:
University of Copenhagen
Collaborating Sponsors:
Technical University of Denmark
KU Leuven
Conditions:
Diet, Healthy
Metabolic Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The aim of this study is to investigate how a short versus a long transit time impacts the gut microbiome's response to a high-fiber and a low-fiber diet, respectively. Such insights could help us und...
Detailed Description
The study consists of two parallel arms of whole-meal diets, a low-fiber diet, and a high-fiber diet, respectively. Each arm is designed as a cross-over where participants, in random order, are admini...
Eligibility Criteria
Inclusion
- 5-30.0 kg/m2 BMI
- Self-reported ≤3.5 spontaneous bowel movements per week
- 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 eat the foods provided.
- Owns a smartphone (iOS 11.0 and later or Android 5.0 and up) with access to the internet.
Exclusion
- Pregnant or lactating women.
- Diagnosis of irritable bowel syndrome (IBS), small intestinal bacterial overgrowth (SIBO), inflammatory bowel diseases (IBD), Gastrointestinal obstruction, or Ischemic colitis
- Diagnosed constipation according to the ROME IV criteria
- Intake of antibiotics ˂ 1month, or any medication that can affect the outcomes of the study
- Regular use of diarrhea inhibitors or laxatives
- Dysphagia
- Any chronic disease that can affect the outcomes of the study or pose a risk when consuming Movicol
- Intake of medications potentially altering gastric pH (proton pump inhibitors, histamine receptor antagonists, antacids)
- Intake of medications potentially altering the gastrointestinal motility (prokinetics, antiemetic agents, anti-cholinergic agents, narcotic analgetics, nonsteroidal anti-inflammatory drugs, and peroral glucocorticoids)
- Concurrent participation in another trial
- Any condition that makes the project responsible researcher to doubt the feasibility of the volunteer´s participation
Key Trial Info
Start Date :
October 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06022302
Start Date
October 3 2023
End Date
November 29 2024
Last Update
March 19 2025
Active Locations (1)
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1
University of Copenhagen, Department of Nutrition, Exercise and Sports
Copenhagen, Denmark, 1958