Actively Recruiting
True Ileal Digestibility of Different Plant-based Proteins in a Human Ileostomy Model
Led by Örebro University, Sweden · Updated on 2025-08-14
11
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how different plant-based proteins are digested in adults aged 18 to 75 who have an ileostomy. The study aims to understand differences in protein digestibility in the small intestine, identify which proteins and amino acids reach the large intestine, compare metabolite profiles after consuming these proteins, and see how these results match with existing lab models. Participants will consume five different meals on separate days in a random order: pea protein with low and high bioavailability, oat protein with low and high bioavailability, and a protein-free meal. Each protein meal is given based on body weight at 0.3 grams of protein per kilogram. The study involves collecting the ileostomy bag contents five hours after each meal to analyze digestion and metabolism. During the study, participants will visit on five different days to consume the meals and provide samples. Researchers will measure the true digestibility of the proteins and analyze protein and metabolite profiles from the ileostomy content. They will also compare these in vivo findings with in vitro data. The study is randomized and triple-masked, with assessments done during the 0-5 hours after meal consumption on each study day.
CONDITIONS
Brief Title
Digestibility of Different Plant-based Proteins in Humans With Ileostomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Body mass index between 18.5 and 30 kg/m2
- Double-loop ileostomy with an intact small bowel
- Signed informed consent
You will not qualify if you...
- Pregnancy or breastfeeding
- Ileostomy less than 3 months before the study
- Any significant disease or condition other than colon cancer that may affect study results
- Any significant medication that may affect study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 study days over several weeks
Participants consume different plant-based protein meals and a protein-free meal in random order on separate study days to assess digestibility.
5 visits (each in-person, one per study day)
Trial Site Locations
Total: 1 location
1
Örebro University
Örebro, Sweden, 70182
Actively Recruiting
Research Team
R
Robert Brummer, PhD
A
Annalena Kamm, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
11
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