True Ileal Digestibility of Different Plant-based Proteins in a Human Ileostomy Model
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Age: 18 - 75 years
• Body mass index: 18.5 - 30 kg/m2
• (double-loop) Ileostomy with an intact small bowel
• Signed informed consent
Locations
Other Locations
Sweden
Örebro University
RECRUITING
Örebro
Contact Information
Primary
Robert Brummer, PhD
robert.brummer@oru.se
004619303731
Backup
Annalena Kamm, MSc
annalena.kamm@oru.se
0046790676822
Time Frame
Start Date: 2025-09
Estimated Completion Date: 2026-09
Participants
Target number of participants: 11
Treatments
Experimental: Dietary Intervention Sequence 1 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))
The participant will consume the below mentioned meals in a random order on five different study days (one on each visit):~* Protein meal: pea protein, low bioavailability~* Protein meal: pea protein, high bioavailability~* Protein meal: oat protein, low bioavailability~* Protein meal: oat protein, high bioavailability~* Protein-free meal
Experimental: Dietary Intervention Sequence 2 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))
The participant will consume the below mentioned meals in a random order on five different study days (one on each visit):~* Protein meal: pea protein, low bioavailability~* Protein meal: pea protein, high bioavailability~* Protein meal: oat protein, low bioavailability~* Protein meal: oat protein, high bioavailability~* Protein-free meal
Experimental: Dietary Intervention Sequence 3 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))
The participant will consume the below mentioned meals in a random order on five different study days (one on each visit):~* Protein meal: pea protein, low bioavailability~* Protein meal: pea protein, high bioavailability~* Protein meal: oat protein, low bioavailability~* Protein meal: oat protein, high bioavailability~* Protein-free meal
Experimental: Dietary Intervention Sequence 4 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))
The participant will consume the below mentioned meals in a random order on five different study days (one on each visit):~* Protein meal: pea protein, low bioavailability~* Protein meal: pea protein, high bioavailability~* Protein meal: oat protein, low bioavailability~* Protein meal: oat protein, high bioavailability~* Protein-free meal
Experimental: Dietary Intervention Sequence 5 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))
The participant will consume the below mentioned meals in a random order on five different study days (one on each visit):~* Protein meal: pea protein, low bioavailability~* Protein meal: pea protein, high bioavailability~* Protein meal: oat protein, low bioavailability~* Protein meal: oat protein, high bioavailability~* Protein-free meal
Experimental: Dietary Intervention Sequence 6 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))
The participant will consume the below mentioned meals in a random order on five different study days (one on each visit):~* Protein meal: pea protein, low bioavailability~* Protein meal: pea protein, high bioavailability~* Protein meal: oat protein, low bioavailability~* Protein meal: oat protein, high bioavailability~* Protein-free meal
Experimental: Dietary Intervention Sequence 7 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))
The participant will consume the below mentioned meals in a random order on five different study days (one on each visit):~* Protein meal: pea protein, low bioavailability~* Protein meal: pea protein, high bioavailability~* Protein meal: oat protein, low bioavailability~* Protein meal: oat protein, high bioavailability~* Protein-free meal
Experimental: Dietary Intervention Sequence 8 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))
The participant will consume the below mentioned meals in a random order on five different study days (one on each visit):~* Protein meal: pea protein, low bioavailability~* Protein meal: pea protein, high bioavailability~* Protein meal: oat protein, low bioavailability~* Protein meal: oat protein, high bioavailability~* Protein-free meal
Experimental: Dietary Intervention Sequence 9 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))
The participant will consume the below mentioned meals in a random order on five different study days (one on each visit):~* Protein meal: pea protein, low bioavailability~* Protein meal: pea protein, high bioavailability~* Protein meal: oat protein, low bioavailability~* Protein meal: oat protein, high bioavailability~* Protein-free meal
Experimental: Dietary Intervention Sequence 10 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))
The participant will consume the below mentioned meals in a random order on five different study days (one on each visit):~* Protein meal: pea protein, low bioavailability~* Protein meal: pea protein, high bioavailability~* Protein meal: oat protein, low bioavailability~* Protein meal: oat protein, high bioavailability~* Protein-free meal
Experimental: Dietary Intervention Sequence 11 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))
The participant will consume the below mentioned meals in a random order on five different study days (one on each visit):~* Protein meal: pea protein, low bioavailability~* Protein meal: pea protein, high bioavailability~* Protein meal: oat protein, low bioavailability~* Protein meal: oat protein, high bioavailability~* Protein-free meal
Related Therapeutic Areas
Sponsors
Leads: Örebro University, Sweden