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RecruitingNCT06142084PAN-ProdigUpdated Jun 23, 2026

Digestibility of Different Plant-based Proteins in Humans With Ileostomy

An interventional study of Oat Protein, low bioavailability and Oat Protein, high bioavailability in Ileostomy - Stoma, sponsored by Örebro University, Sweden. Recruiting at 1 site in Sweden. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-23.

Sponsored by Örebro University, Sweden · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

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.

02

Conditions studied

  • Ileostomy - Stoma

Keywords

  • Protein
  • Plant-based
  • Digestibility
03

In context

Lead sponsor

Örebro University, Sweden is the lead sponsor of 86 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Ileostomy \< 3 months before the study
  • Any 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
11 participants (estimated)

Study arms

  • Experimental
    Dietary Intervention Sequence 1 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))

    The participant will consume the below mentioned meals in a random order on five different study days (one on each visit): * Protein meal: pea protein, low bioavailability * Protein meal: pea protein, high bioavailability * Protein meal: oat protein, low bioavailability * Protein meal: oat protein, high bioavailability * Protein-free meal

    Dietary Supplement: Oat Protein, low bioavailability · Dietary Supplement: Oat Protein, high bioavailability · Dietary Supplement: Pea Protein, low bioavailability · Dietary Supplement: Pea Protein, high bioavailability · Dietary Supplement: Protein-free meal

  • Experimental
    Dietary Intervention Sequence 2 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))

    The participant will consume the below mentioned meals in a random order on five different study days (one on each visit): * Protein meal: pea protein, low bioavailability * Protein meal: pea protein, high bioavailability * Protein meal: oat protein, low bioavailability * Protein meal: oat protein, high bioavailability * Protein-free meal

    Dietary Supplement: Oat Protein, low bioavailability · Dietary Supplement: Oat Protein, high bioavailability · Dietary Supplement: Pea Protein, low bioavailability · Dietary Supplement: Pea Protein, high bioavailability · Dietary Supplement: Protein-free meal

  • Experimental
    Dietary Intervention Sequence 3 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))

    The participant will consume the below mentioned meals in a random order on five different study days (one on each visit): * Protein meal: pea protein, low bioavailability * Protein meal: pea protein, high bioavailability * Protein meal: oat protein, low bioavailability * Protein meal: oat protein, high bioavailability * Protein-free meal

    Dietary Supplement: Oat Protein, low bioavailability · Dietary Supplement: Oat Protein, high bioavailability · Dietary Supplement: Pea Protein, low bioavailability · Dietary Supplement: Pea Protein, high bioavailability · Dietary Supplement: Protein-free meal

  • Experimental
    Dietary Intervention Sequence 4 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))

    The participant will consume the below mentioned meals in a random order on five different study days (one on each visit): * Protein meal: pea protein, low bioavailability * Protein meal: pea protein, high bioavailability * Protein meal: oat protein, low bioavailability * Protein meal: oat protein, high bioavailability * Protein-free meal

    Dietary Supplement: Oat Protein, low bioavailability · Dietary Supplement: Oat Protein, high bioavailability · Dietary Supplement: Pea Protein, low bioavailability · Dietary Supplement: Pea Protein, high bioavailability · Dietary Supplement: Protein-free meal

  • Experimental
    Dietary Intervention Sequence 5 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))

    The participant will consume the below mentioned meals in a random order on five different study days (one on each visit): * Protein meal: pea protein, low bioavailability * Protein meal: pea protein, high bioavailability * Protein meal: oat protein, low bioavailability * Protein meal: oat protein, high bioavailability * Protein-free meal

    Dietary Supplement: Oat Protein, low bioavailability · Dietary Supplement: Oat Protein, high bioavailability · Dietary Supplement: Pea Protein, low bioavailability · Dietary Supplement: Pea Protein, high bioavailability · Dietary Supplement: Protein-free meal

  • Experimental
    Dietary Intervention Sequence 6 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))

    The participant will consume the below mentioned meals in a random order on five different study days (one on each visit): * Protein meal: pea protein, low bioavailability * Protein meal: pea protein, high bioavailability * Protein meal: oat protein, low bioavailability * Protein meal: oat protein, high bioavailability * Protein-free meal

    Dietary Supplement: Oat Protein, low bioavailability · Dietary Supplement: Oat Protein, high bioavailability · Dietary Supplement: Pea Protein, low bioavailability · Dietary Supplement: Pea Protein, high bioavailability · Dietary Supplement: Protein-free meal

  • Experimental
    Dietary Intervention Sequence 7 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))

    The participant will consume the below mentioned meals in a random order on five different study days (one on each visit): * Protein meal: pea protein, low bioavailability * Protein meal: pea protein, high bioavailability * Protein meal: oat protein, low bioavailability * Protein meal: oat protein, high bioavailability * Protein-free meal

    Dietary Supplement: Oat Protein, low bioavailability · Dietary Supplement: Oat Protein, high bioavailability · Dietary Supplement: Pea Protein, low bioavailability · Dietary Supplement: Pea Protein, high bioavailability · Dietary Supplement: Protein-free meal

  • Experimental
    Dietary Intervention Sequence 8 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))

    The participant will consume the below mentioned meals in a random order on five different study days (one on each visit): * Protein meal: pea protein, low bioavailability * Protein meal: pea protein, high bioavailability * Protein meal: oat protein, low bioavailability * Protein meal: oat protein, high bioavailability * Protein-free meal

    Dietary Supplement: Oat Protein, low bioavailability · Dietary Supplement: Oat Protein, high bioavailability · Dietary Supplement: Pea Protein, low bioavailability · Dietary Supplement: Pea Protein, high bioavailability · Dietary Supplement: Protein-free meal

  • Experimental
    Dietary Intervention Sequence 9 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))

    The participant will consume the below mentioned meals in a random order on five different study days (one on each visit): * Protein meal: pea protein, low bioavailability * Protein meal: pea protein, high bioavailability * Protein meal: oat protein, low bioavailability * Protein meal: oat protein, high bioavailability * Protein-free meal

    Dietary Supplement: Oat Protein, low bioavailability · Dietary Supplement: Oat Protein, high bioavailability · Dietary Supplement: Pea Protein, low bioavailability · Dietary Supplement: Pea Protein, high bioavailability · Dietary Supplement: Protein-free meal

  • Experimental
    Dietary Intervention Sequence 10 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))

    The participant will consume the below mentioned meals in a random order on five different study days (one on each visit): * Protein meal: pea protein, low bioavailability * Protein meal: pea protein, high bioavailability * Protein meal: oat protein, low bioavailability * Protein meal: oat protein, high bioavailability * Protein-free meal

    Dietary Supplement: Oat Protein, low bioavailability · Dietary Supplement: Oat Protein, high bioavailability · Dietary Supplement: Pea Protein, low bioavailability · Dietary Supplement: Pea Protein, high bioavailability · Dietary Supplement: Protein-free meal

  • Experimental
    Dietary Intervention Sequence 11 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))

    The participant will consume the below mentioned meals in a random order on five different study days (one on each visit): * Protein meal: pea protein, low bioavailability * Protein meal: pea protein, high bioavailability * Protein meal: oat protein, low bioavailability * Protein meal: oat protein, high bioavailability * Protein-free meal

    Dietary Supplement: Oat Protein, low bioavailability · Dietary Supplement: Oat Protein, high bioavailability · Dietary Supplement: Pea Protein, low bioavailability · Dietary Supplement: Pea Protein, high bioavailability · Dietary Supplement: Protein-free meal

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.

06

What researchers measure

Primary outcomes

  1. True ileal digestibility of different plant-based proteins

    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

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

Secondary outcomes

  1. Protein and metabolite profiles in ileostomy digesta

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

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

  2. Differences between in vivo and in vitro data

    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

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06142084
Lead sponsor
Örebro University, Sweden
Responsible party
Sponsor
First posted
Nov 21, 2023
Start date
Sep 2026 (estimated)
Primary completion
Sep 2027 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jun 23, 2026

Study contacts

Robert Brummer, PhD
Contact
robert.brummer@oru.se
004619303731
Annalena Kamm, MSc
Contact
annalena.kamm@oru.se
0046790676822

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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