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Why Calories Are Not the Same - a Gut Explanation?

NCT06932666 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-31

No results posted yet for this study

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.

Conditions

  • Diet, Healthy
  • Breath Analysis

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • Wageningen University and Research

    collaborator OTHER

  • University of Copenhagen

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-15
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06932666 on ClinicalTrials.gov