Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2025-05-15
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Before the trial, participants undergo a screening period of 4 days. During the 4-day screening period, participants measure the levels of methane in their exhaled breath. Based on median breath methane levels, participants are allocated to one of the two arms: (HMP: high methane producers; LMP: low methane producers). Enrollment in the intervention trial will be conducted so there are similar numbers of participants in both arms.
At the beginning and at the end of each 3-day intervention period, participants consume a blue muffin, containing a royal blue dye that changes the stool color. The appearance of the color in stool following the first muffin will mark the beginning of the stool collection period, which will continue until the stool color change is no longer noticeable following consumption of the second muffin. Therefore, the duration of the stool collection period, which is estimated to be on average 3 days, will ultimately depend on the participants' passage time of food (i.e., intestinal transit time).
During the screening period, participants are asked to:
* measure their methane and hydrogen levels in exhaled breath using a portable device
* report defecation patterns (including stool frequency and Bristol Stool Scale)
Before each intervention period, participants are asked to:
* collect a fecal and urine sample
* register three days of habitual diet
At the visits before each intervention period, the following samples are collected:
* a blood sample
* methane and hydrogen measurements in exhaled breath
* anthropometrics
* data on physical activity
During the intervention periods, participants are asked to:
* exclusively eat all the foods provided
* collect all their stool samples, as specified above
* collect three morning urine samples (one daily for the following three days)
* measure their methane and hydrogen levels in their exhaled breath using a portable device
* report their defecation patterns and gastrointestinal symptoms
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
CROSSOVER
In both arms, participants undergo two 3-days dietary interventions in a crossover design and separated by a +10-day washout period. Participants are randomized to receiving diet A first or diet B first. These two diets are isocaloric and equal in macronutrient composition, but differ on dietary fiber, resistant starch and food particle size.
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
High-methane producers
Individuals exhaling high levels of methane (median exhaled methane \>= 5 ppm), as measured 3-times daily during the screening period.
Diet A group
Diet high in fiber (\> 40g/10MJ), high in resistant starch (\> 10g/10MJ), and containing large food particles. Diet is provided for 3 full days, consists of three meals per day (breakfast, lunch, and dinner) and in-between meals, and covers 100% of the participants' energy requirements.
Diet B group
Diet low in fiber (\< 10g/10MJ), low in resistant starch (\< 3g/10MJ) and containing small food particles. Diet is provided for 3 full days, consists of three meals per day (breakfast, lunch, and dinner) and in-between meals, and covers 100% of the participants' energy requirements.
Low-methane producers
Individuals exhaling low levels of methane (median exhaled methane \< 5 ppm), as measured 3-times daily during the screening period.
Diet A group
Diet high in fiber (\> 40g/10MJ), high in resistant starch (\> 10g/10MJ), and containing large food particles. Diet is provided for 3 full days, consists of three meals per day (breakfast, lunch, and dinner) and in-between meals, and covers 100% of the participants' energy requirements.
Diet B group
Diet low in fiber (\< 10g/10MJ), low in resistant starch (\< 3g/10MJ) and containing small food particles. Diet is provided for 3 full days, consists of three meals per day (breakfast, lunch, and dinner) and in-between meals, and covers 100% of the participants' energy requirements.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Diet A group
Diet high in fiber (\> 40g/10MJ), high in resistant starch (\> 10g/10MJ), and containing large food particles. Diet is provided for 3 full days, consists of three meals per day (breakfast, lunch, and dinner) and in-between meals, and covers 100% of the participants' energy requirements.
Diet B group
Diet low in fiber (\< 10g/10MJ), low in resistant starch (\< 3g/10MJ) and containing small food particles. Diet is provided for 3 full days, consists of three meals per day (breakfast, lunch, and dinner) and in-between meals, and covers 100% of the participants' energy requirements.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Wageningen University and Research
OTHER
University of Copenhagen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Henrik Munch Roager
Associate Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Copenhagen, Department of Nutrition, Exercise and Sports
Frederiksberg, Capital Region, Denmark
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Henrik M Roager, PhD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M408
Identifier Type: -
Identifier Source: org_study_id