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Recruiting Not applicable

Digestibility of Different Plant-based Proteins in Humans With Ileostomy

NCT06142084 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2026-09
Last updated
2026-06-23

Condition(s) studied

Ileostomy - Stoma

Investigational drug(s) / intervention(s)

Oat Protein, low bioavailabilityOat Protein, high bioavailabilityPea Protein, low bioavailabilityPea Protein, high bioavailabilityProtein-free meal

Oat 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).

Oat 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).

Pea 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).

Pea 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).

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

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • True ileal digestibility of different plant-based proteins — 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

Trial sites (1)

FacilityCityRegionStatus
Örebro University Örebro Sweden Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06142084 on ClinicalTrials.gov ↗ ← All trials in Sweden