NCT06142084

Digestibility of Different Plant-based Proteins in Humans With Ileostomy

True Ileal Digestibility of Different Plant-based Proteins in a Human Ileostomy Model

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (estimated)
• Sponsor: Örebro University, Sweden · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ileostomy - Stoma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Oat Protein, low bioavailability	Participants will consume a protein meal consisting of cooked whole oat kernels (amount based on body weight, 0.3g of protein/kg bodyweight).
DIETARY_SUPPLEMENT	Oat Protein, high bioavailability	Participants will consume a protein meal consisting of heated oat protein concentrate (amount based on body weight, 0.3g of protein/kg bodyweight).
DIETARY_SUPPLEMENT	Pea Protein, low bioavailability	Participants will consume a protein meal consisting of cooked whole yellow peas (amount based on body weight, 0.3g of protein/kg bodyweight).
DIETARY_SUPPLEMENT	Pea Protein, high bioavailability	Participants will consume a protein meal consisting of heated pea protein isolate (amount based on body weight, 0.3g of protein/kg bodyweight).
DIETARY_SUPPLEMENT	Protein-free meal	Participants will consume a protein-free meal to correct analyses for endogenous protein losses.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-04-01
• Completion: 2026-09-01
• First posted: 2023-11-21
• Last updated: 2025-08-14

Locations

1 site across 1 country: Sweden