Digestibility of Different Plant-based Proteins in Humans With Ileostomy

NCT06142084 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-08-14

No results posted yet for this 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.

Conditions

  • Ileostomy - Stoma

Interventions

DIETARY_SUPPLEMENT

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).

DIETARY_SUPPLEMENT

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).

DIETARY_SUPPLEMENT

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).

DIETARY_SUPPLEMENT

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).

DIETARY_SUPPLEMENT

Protein-free meal

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

Sponsors & Collaborators

  • Örebro University, Sweden

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-04-30
Completion
2026-09-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06142084 on ClinicalTrials.gov