Digestibility of Different Plant-based Proteins in Humans With Ileostomy
NCT06142084 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2025-08-14
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
- 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.
Sponsors & Collaborators
-
Örebro University, Sweden
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-30
- Primary Completion
- 2026-04-30
- Completion
- 2026-09-30
Countries
- Sweden
Study Locations
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