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

Inclusion Criteria4

  • Age: 18 - 75 years
  • Body mass index: 18.5 - 30 kg/m2
  • (double-loop) Ileostomy with an intact small bowel
  • Signed informed consent

Exclusion Criteria4

  • 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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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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