Digestibility of Different Plant-based Proteins in Humans With Ileostomy
Condition(s) studied
Investigational drug(s) / intervention(s)
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).
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).
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).
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).
Protein-free meal: Participants will consume a protein-free meal to correct analyses for endogenous protein losses.
Study 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.
Eligibility
Primary outcome measure(s)
- 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
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Örebro University | Örebro | Sweden | Recruiting |
More Örebro University, Sweden trials in Sweden
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06142084 on ClinicalTrials.gov ↗ ← All trials in Sweden