Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-26 @ 10:51 PM
Study NCT ID:
NCT06932666
Status:
RECRUITING
Last Update Posted:
2025-07-01
First Post:
2025-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Why Calories Are Not the Same - a Gut Explanation?
Sponsor:
University of Copenhagen
Organization:
Study Overview
Official Title:
Why Calories Are Not the Same - a Gut Explanation
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GutEnergy
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 breath represent two different gut microbiome community structures, and therefore influence fecal energy excretion differently. Moreover, this study is assessed in the context of two different diets, both isocaloric and equal in macronutrient composition, but differing in contents of fiber, resistant starch, and large particles; which are hypothesized to impact the gut microbiome differently.
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, and food particle sizes. Each intervention is separated by a wash-out period of at least 10 days where participants adhere to their habitual diet. The trial includes a total of five visits (one screening visit and four regular visits).
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: