Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06142084
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2023-11-15
Brief Title:
Digestibility of Different Plant-based Proteins in Humans With Ileostomy
Sponsor:
Örebro University Sweden
Organization:
Örebro University Sweden
Study Overview
Official Title:
True Ileal Digestibility of Different Plant-based Proteins in a Human Ileostomy Model
Status:
RECRUITING
Status Verified Date:
2024-04
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:
PAN-Prodig
Brief Summary:
The goal of this interventional study is to learn about the digestibility of different plant-based proteins in adults age 18-75 with an ileostomy
The main questions the study aims to answer are
1 How does the digestibility of proteins in the small intestine differ between different plant-based proteins
2 Which proteins and amino acids are not digested or absorbed in the small intestine and are available for further metabolic processes in the large intestine
3 How do metabolites in the collected content of the ileostomy bag differ after consuming different plant-based proteins
4 Can the in vivo results be compared to results from existing in vitro models
Participants will consume five different protein meals oat protein - high bioavailable oat protein - low bioavailable pea protein - high bioavailable pea protein low bioavailable protein-free meal on five different study days in a random order Five hours after consuming the test meals ileostomy bags will be collected and the content will be analysed to answer the above mentioned research questions
The main questions the study aims to answer are
1 How does the digestibility of proteins in the small intestine differ between different plant-based proteins
2 Which proteins and amino acids are not digested or absorbed in the small intestine and are available for further metabolic processes in the large intestine
3 How do metabolites in the collected content of the ileostomy bag differ after consuming different plant-based proteins
4 Can the in vivo results be compared to results from existing in vitro models
Participants will consume five different protein meals oat protein - high bioavailable oat protein - low bioavailable pea protein - high bioavailable pea protein low bioavailable protein-free meal on five different study days in a random order Five hours after consuming the test meals ileostomy bags will be collected and the content will be analysed to answer the above mentioned research questions
Detailed Description:
None
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