University of Copenhagen, Department of Nutrition, Exercise and Sports
Frederiksberg, Capital Region, 1958, Denmark
NCT Number: NCT06932666
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Frederiksberg, Capital Region, 1958, Denmark
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:
Before each intervention period, participants are asked to:
At the visits before each intervention period, the following samples are collected:
During the intervention periods, participants are asked to:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
Time frame: During each stool collection period (following each 3-day intervention period)
Differences in total fecal energy excretion, determined as total kilocalories excreted via feces, between low and high methane producers following intake of the two controlled, isocaloric diets.
Time frame: During each stool collection period (following each 3-day intervention period)
Differences in total fecal energy excretion, determined as total kilocalories excreted via feces, between the two isocaloric diets (that differ in fiber, resistant starch, and particle size).
Time frame: During each 3-day intervention period and its following stool collection period
Differences in fecal energy density, determined as fecal energy (kcal) relative to fecal weight, between high- and low-methane producers.
Time frame: During each 3-day intervention period and its following stool collection period
Differences in total fecal weight excreted, determined as dry weight (grams), between high- and low-methane producers.
Time frame: During each 3-day intervention period and its following stool collection period
Differences in breath methane and hydrogen concentration in exhaled breath, measured in parts per million (PPM), between high- and low-methane producers.
Time frame: During each 3-day intervention period and its following stool collection period
Differences in whole-gut transit time, determined by the passage time of muffins with blue dye, between high- and low-methane producers.
Time frame: During each 3-day intervention period and its following stool collection period
Differences in stool consistency, determined by Bristol Stool Scale, between high- and low-methane producers.
Time frame: During each 3-day intervention period and its following stool collection period
Differences in stool frequency, determined by defecation records registered by the participants, between high- and low-methane producers.
Time frame: During each 3-day intervention period and its following stool collection period
Differences in stool moisture, determined as fecal water content relative to fecal weight, between high- and low-methane producers.
Time frame: During each 3-day intervention period and its following stool collection period
Differences in fecal pH between high- and low-methane producers.
Time frame: During each 3-day intervention period and its following stool collection period
Differences in fecal microbial load, determined as total microbial DNA reads in feces, between high- and low-methane producers.
Time frame: During each 3-day intervention period and its following stool collection period
Differences in fecal host DNA concentration, determined as total human DNA reads in feces, between high- and low-methane producers.
Time frame: During each 3-day intervention period and its following stool collection period
Differences in fecal short-chain fatty acid concentrations between high- and low-methane producers.
Time frame: During each 3-day intervention period and its following stool collection period
Differences in gut microbiome composition, determined by 16S amplicon sequencing of fecal DNA, between high- and low-methane producers.
Time frame: During each 3-day intervention period and its following stool collection period
Differences in gut microbiome taxonomic composition and functions, determined by shotgun sequencing of fecal DNA, between high- and low-methane producers.
Time frame: During each 3-day intervention period and its following stool collection period
Differences in gut microbiome-derived metabolites, such as short-chain fatty acids, bile acids, amino acid-derived metabolites, and other metabolites derived from microbial proteolytic and saccharolytic fermentation measured from fecal samples, between high- and low-methane producers.
Time frame: Before and during each 3-day intervention period
Differences in gut microbiome-derived metabolites, such as short-chain fatty acids, bile acids, amino acid-derived metabolites, and other metabolites derived from microbial proteolytic and saccharolytic fermentation measured from urine samples, between high- and low-methane producers.
Time frame: Right before each 3-day intervention period
Differences in gut microbiome-derived metabolites, such as short-chain fatty acids, bile acids, amino acid-derived metabolites, and other metabolites derived from microbial proteolytic and saccharolytic fermentation measured from blood samples, between high- and low-methane producers.
Time frame: During each 3-day intervention period and its following stool collection period
Differences in the fecal metabolome, measured by LC-MS/MS untargeted metabolomics, between high- and low-methane producers.
Time frame: Before and during each 3-day intervention period
Differences in the urine metabolome, measured by LC-MS/MS untargeted metabolomics, between high- and low-methane producers.
Time frame: Right before each 3-day intervention period
Differences in the blood metabolome, measured by LC-MS/MS untargeted metabolomics, between high- and low-methane producers.
Time frame: During each 3-day intervention period
Differences in the gastrointestinal symptoms during the 3-day intervention period, measured using a visual analog scale, between high- and low-methane producers.
Time frame: Right before each 3-day intervention period
Differences in habitual diet records registered by participants, between high- and low-methane producers.
Time frame: Baseline (before the first 3-day intervention period)
Differences in habitual physical activity records registered by participants, between high- and low-methane producers.
Time frame: Right before each 3-day intervention period
Differences in body weight before intervention, between high- and low-methane producers.
Time frame: Baseline (before the first 3-day intervention period)
Differences in body fat composition, measured through Dual-Energy X-ray Absorptiometry (DXA scan), between high- and low-methane producers.
Time frame: Baseline (before the first 3-day intervention period)
Differences in muscle composition, measured through Dual-Energy X-ray Absorptiometry (DXA scan), between high- and low-methane producers.
Time frame: Baseline (before the first 3-day intervention period)
Differences in bone composition, measured through Dual-Energy X-ray Absorptiometry (DXA scan), between high- and low-methane producers.
Time frame: During each 3-day intervention period and its following stool collection period
Differences in biomarkers of food intake, measured by untargeted metabolomics and food DNA in fecal samples, between high- and low-methane producers.
Time frame: Before and during each 3-day intervention period
Differences in biomarkers of food intake, measured by untargeted metabolomics in urine samples, between high- and low-methane producers.
Time frame: Right before each 3-day intervention period
Differences in biomarkers of food intake, measured by untargeted metabolomics in blood samples, between high- and low-methane producers.
Time frame: During each 3-day intervention period and its following stool collection period
Differences in fecal particle size between high- and low-methane producers.
Time frame: During each 3-day intervention period and its following stool collection period
Differences in fecal carbon-to-nitrogen ratio between high- and low-methane producers.
Time frame: During each 3-day intervention period and its following stool collection period
Differences in fecal redox potential, measured in millivolts (mV), between high- and low-methane producers.
Time frame: During each 3-day intervention period and its following stool collection period
Differences in fecal biomarkers of inflammation, determined by fecal calprotectin, between high- and low-methane producers.
Time frame: During each 3-day intervention period and its following stool collection period
Differences in fecal biomarkers of intestinal permeability, determined by fecal zonulin, between high- and low-methane producers.
Time frame: Right before each 3-day intervention period
Differences in blood markers of glucose metabolism, such as glucose, insulin and HbA1C, between high- and low-methane producers.
Time frame: Right before each 3-day intervention period
Differences in blood markers of lipid metabolism, such as total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides, between high- and low-methane producers.
Time frame: Right before each 3-day intervention period
Differences in blood markers of inflammation, such as CRP, IL-6, TNF-α, and other cytokines, between high- and low-methane producers.
Time frame: Right before each 3-day intervention period
Differences in blood markers of appetite, such as glucagon, GLP-1, GLP-2, PYY, leptin, ghrelin, GIP, and CCK, between high- and low-methane producers.
Time frame: Right before each 3-day intervention period
Differences in blood markers of intestinal permeability, such as lipopolysaccharide-binding protein (LBP), between high- and low-methane producers.
University of Copenhagen
Other
Why Calories Are Not the Same - a Gut Explanation
Acronym: GutEnergy
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