RecruitingNot ApplicableNCT06142084

Digestibility of Different Plant-based Proteins in Humans With Ileostomy

True Ileal Digestibility of Different Plant-based Proteins in a Human Ileostomy Model


Sponsor

Örebro University, Sweden

Enrollment

11 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study examines how well the small intestine digests and absorbs proteins from plant-based foods — specifically oat and pea proteins with different bioavailability profiles — in adults who have had an ileostomy (a surgical opening where the small intestine exits the body into a bag). Because ileostomy patients can have the contents of their small intestine collected and analyzed, this is a unique opportunity to study digestion directly without invasive testing. Adults aged 18–75 with a BMI of 18.5–30 and a functioning ileostomy of at least 3 months may be eligible. Participation involves eating five different protein test meals on separate days and having the ileostomy bag contents collected 5 hours after each meal for laboratory analysis. This summary was generated by AI to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTOat 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_SUPPLEMENTOat 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_SUPPLEMENTPea 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_SUPPLEMENTPea 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_SUPPLEMENTProtein-free meal

Participants will consume a protein-free meal to correct analyses for endogenous protein losses.


Locations(1)

Örebro University

Örebro, Sweden

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NCT06142084


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