Digestibility of Different Plant-based Proteins in Humans With Ileostomy

Not Applicable

Recruiting

• Conditions: Ileostomy - Stoma

• Registration Number: NCT06142084
• Lead Sponsor: Örebro University, Sweden

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-15
• Study First Posted: 2023-11-21
• Status Verified: 2024-04
• Study Start: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Age: 18 - 75 years
• Body mass index: 18.5 - 30 kg/m2
• (double-loop) Ileostomy with an intact small bowel
• Signed informed consent

Exclusion Criteria

• Pregnancy or breastfeeding
• Ileostomy < 3 months before the study
• Any clinically significant present or past disease/condition other than colon cancer which in the investigator's opinion could interfere with the results of the trial
• Any clinically significant present or past medication which in the investigator's opinion could interfere with the results of the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
True ileal digestibility of different plant-based proteins	0-5 hours after consumption of test meal (on all 5 study days)	The primary outcome is defined as the differences in the true ileal digestibility, determined by measuring the amount of nitrogen in the meal and the amount of unabsorbed nitrogen in the ileal fluid after consuming four different plant-based protein meals

Secondary Outcome Measures

Name	Time	Method
Protein and metabolite profiles in ileostomy digesta	0-5 hours after consumption of test meal (on all 5 study days)	The secondary outcomes are defined as changes in protein and metabolite profiles in the digesta, determined by proteomics and metabolomic analyses.
Differences between in vivo and in vitro data	In vivo data: 0-5 hours after consumption of test meal (on all 5 study days)	Results from the human ileostomy model will be compared with results from in vitro digestion according to the Infogest 2.0 protocol for each of the tested plant-based proteins

Trial Locations

Locations (1)

Örebro University; 🇸🇪 Örebro, Sweden