Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06142084

Digestibility of Different Plant-based Proteins in Humans With Ileostomy

Led by Örebro University, Sweden · Updated on 2025-08-14

11

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Digestibility of Different Plant-based Proteins in Humans With Ileostomy

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years
  • Body mass index between 18.5 and 30 kg/m2
  • Having a (double-loop) ileostomy with an intact small bowel
  • Signed informed consent to participate
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Ileostomy less than 3 months old
  • Any significant current or past disease/condition except colon cancer that could affect study results
  • Any significant current or past medication that could affect study results

AI-Screening

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Trial Site Locations

Total: 1 location

1

Örebro University

Örebro, Sweden, 70182

Actively Recruiting

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Research Team

R

Robert Brummer, PhD

CONTACT

A

Annalena Kamm, MSc

CONTACT

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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