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NCT Number: NCT06142084

Digestibility of Different Plant-based Proteins in Humans With Ileostomy

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.

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Key information

Conditions

Ileostomy - Stoma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oat Protein, low bioavailability

Dietary Supplement

Participants will consume a protein meal consisting of cooked whole oat kernels (amount based on body weight, 0.3g of protein/kg bodyweight).

Oat Protein, high bioavailability

Dietary Supplement

Participants will consume a protein meal consisting of heated oat protein concentrate (amount based on body weight, 0.3g of protein/kg bodyweight).

Pea Protein, low bioavailability

Dietary Supplement

Participants will consume a protein meal consisting of cooked whole yellow peas (amount based on body weight, 0.3g of protein/kg bodyweight).

Pea Protein, high bioavailability

Dietary Supplement

Participants will consume a protein meal consisting of heated pea protein isolate (amount based on body weight, 0.3g of protein/kg bodyweight).

Protein-free meal

Dietary Supplement

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

Primary outcomes

  1. True ileal digestibility of different plant-based proteins

    Time frame: 0-5 hours after consumption of test meal (on all 5 study days)

    The primary outcome is defined as the differences in the true ileal digestibility, determined by measuring the amount of nitrogen in the meal and the amount of unabsorbed nitrogen in the ileal fluid after consuming four different plant-based protein meals

Secondary outcomes

  1. Protein and metabolite profiles in ileostomy digesta

    Time frame: 0-5 hours after consumption of test meal (on all 5 study days)

    The secondary outcomes are defined as changes in protein and metabolite profiles in the digesta, determined by proteomics and metabolomic analyses.

  2. Differences between in vivo and in vitro data

    Time frame: In vivo data: 0-5 hours after consumption of test meal (on all 5 study days)

    Results from the human ileostomy model will be compared with results from in vitro digestion according to the Infogest 2.0 protocol for each of the tested plant-based proteins

Study contacts

Contact information is provided by the study sponsor or research team.

Annalena Kamm, MSc

CONTACT

[email protected]

0046790676822

Robert Brummer, PhD

CONTACT

[email protected]

004619303731

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Registry information

Official study title

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

Acronym: PAN-Prodig

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Nov 21, 2023
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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