Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04804319
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2021-03-04
Brief Title:
Interactions Between Diet Microbiome and Abiotic Conditions in the Gut
Sponsor:
University of Copenhagen
Organization:
University of Copenhagen
Study Overview
Official Title:
Towards Personalized Dietary Recommendations Based on the Interaction Between Diet Microbiome and Abiotic Conditions in the Gut
Status:
COMPLETED
Status Verified Date:
2024-10
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:
PRIMA
Brief 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
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
Study Oversight
Has Oversight DMC:
None
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?:
None