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Recruiting NCT06142084

Digestibility of Different Plant-based Proteins in Humans With Ileostomy

Trial Parameters

Condition Ileostomy - Stoma
Sponsor Örebro University, Sweden
Study Type INTERVENTIONAL
Phase N/A
Enrollment 11
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2025-09
Completion 2026-04
Interventions
Oat Protein, low bioavailabilityOat Protein, high bioavailabilityPea Protein, low bioavailability

Brief 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 Criteria

Inclusion Criteria: * Age: 18 - 75 years * Body mass index: 18.5 - 30 kg/m2 * (double-loop) Ileostomy with an intact small bowel * Signed informed consent Exclusion Criteria: * Pregnancy or breastfeeding * Ileostomy \< 3 months before the study * Any clinically significant present or past disease/condition other than colon cancer which in the investigator's opinion could interfere with the results of the trial * Any clinically significant present or past medication which in the investigator's opinion could interfere with the results of the trial

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