Clinical Trials Directory

Trials / Completed

CompletedNCT04804319

Interactions Between Diet, Microbiome and Abiotic Conditions in the Gut

Towards Personalized Dietary Recommendations Based on the Interaction Between Diet, Microbiome and Abiotic Conditions in the Gut

Status
Completed
Phase
Study type
Observational
Enrollment
63 (actual)
Sponsor
University of Copenhagen · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

Summary

The aim of this study is to explore the interplay between environmental (abiotic) factors in the gut and the gut microbiota composition, diversity and metabolism. Such insights could help us understand personal responses to diets and be a first step towards personalized dietary recommendations targeting the gut microbiome.

Detailed description

The study is a 9-day trial including 85 healthy adults in age between 18 and 75. The participants will throughout the trial register their dietary intake, gastrointestinal symptoms including stool frequency and Bristol stool scale, physical activity, and medicine and supplements intake. Participants will on day 3 and day 5, respectively, consume sweet corns to estimate intestinal transit time by the time it takes sweet corn to travel through the gastrointestinal system. Furthermore, the participants will collect daily urine and stool samples. On day 2 and day 9, participants will arrive fasting at the department in the morning and have their anthropometry, breath hydrogen and methane levels measured, and a blood sample will be collected from each participant. The first visit (day 2) also includes a standardized meal test (rye bread, butter, jam, egg, and yogurt with nuts and berries) and intake of paracetamol (250 mg). Subsequently, the participants will stay at the department for the following 6 hours and have their postprandial breath hydrogen and methane measured and urine collected at specific intervals. Moreover, a sub-set of the participants will on the first visit (day 2) immediately after intake of the standardized meal swallow a single-use gastrointestinal SmartPill capsule, which will monitor their gastrointestinal pH, transit time, temperature and pressure.

Conditions

Interventions

TypeNameDescription
OTHER9-days habitual diet9-days study with habitual diet including one standardized breakfast on a single day

Timeline

Start date
2021-04-13
Primary completion
2021-11-29
Completion
2021-11-29
First posted
2021-03-18
Last updated
2024-12-06

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT04804319. Inclusion in this directory is not an endorsement.