Ileostomy - StomaPAN-ProdigNCT06142084
Digestibility of Different Plant-based Proteins in Humans With Ileostomy
A study testing Oat Protein, low bioavailability, Oat Protein, high bioavailability and Pea Protein, low bioavailability in people with Ileostomy - Stoma, run by Örebro University, Sweden at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ileostomy - Stoma
- What is being tested?
- Oat Protein, low bioavailability, Oat Protein, high bioavailability and Pea Protein, low bioavailability
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 - 75 years
- Body mass index: 18.5 - 30 kg/m2
- (double-loop) Ileostomy with an intact small bowel
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Örebro University
Örebro, 70182
Robert Brummer, PhD, 004619303731, robert.brummer@oru.se
About this study
Official title: True Ileal Digestibility of Different Plant-based Proteins in a Human Ileostomy Model
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:
Read more
- How does the digestibility of proteins in the small intestine differ between different plant-based proteins?
- 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?
- How do metabolites in the collected content of the ileostomy bag differ after consuming different plant-based proteins?
- 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
- Being tested
- Oat Protein, low bioavailability, Oat Protein, high bioavailability, Pea Protein, low bioavailability, Pea Protein, high bioavailability, Protein-free meal
- Keywords
- Protein, Plant-based, Digestibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oat Protein, low bioavailabilityDietary 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 bioavailabilityDietary 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 bioavailabilityDietary 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 bioavailabilityDietary 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 mealDietary supplement
Participants will consume a protein-free meal to correct analyses for endogenous protein losses.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Intervention Sequence 1 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) | Experimental | 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 Receives: 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 |
| Dietary Intervention Sequence 2 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) | Experimental | 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 Receives: 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 |
| Dietary Intervention Sequence 3 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) | Experimental | 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 Receives: 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 |
| Dietary Intervention Sequence 4 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) | Experimental | 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 Receives: 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 |
| Dietary Intervention Sequence 5 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) | Experimental | 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 Receives: 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 |
| Dietary Intervention Sequence 6 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) | Experimental | 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 Receives: 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 |
| Dietary Intervention Sequence 7 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) | Experimental | 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 Receives: 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 |
| Dietary Intervention Sequence 8 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) | Experimental | 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 Receives: 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 |
| Dietary Intervention Sequence 9 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) | Experimental | 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 Receives: 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 |
| Dietary Intervention Sequence 10 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) | Experimental | 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 Receives: 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 |
| Dietary Intervention Sequence 11 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) | Experimental | 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-5 hours after consumption of test meal (on all 5 study days)
Secondary outcomes (2)
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.
Measured: 0-5 hours after consumption of test meal (on all 5 study days)
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
Measured: In vivo data: 0-5 hours after consumption of test meal (on all 5 study days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ileostomy - StomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142084
- Sponsor's protocol ID
- Dnr 2023-04189-01
- Acronym
- PAN-Prodig
- Status last verified
- Jun 2026
- First submitted
- 15 Nov 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- True Ileal Digestibility of Different Plant-based Proteins in a Human Ileostomy Model
- ClinicalTrials.gov ID
- NCT06142084
- Acronym / sponsor ID
- PAN-Prodig / Dnr 2023-04189-01
- Conditions
- Ileostomy - Stoma
- Keywords
- Protein, Plant-based, Digestibility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How does the digestibility of proteins in the small intestine differ between different plant-based proteins?
- 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?
- How do metabolites in the collected content of the ileostomy bag differ after consuming different plant-based proteins?
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Dietary Intervention Sequence 1 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) | Experimental | 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 mealThe 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 Intervention Sequence 2 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) | Experimental | 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 mealThe 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 Intervention Sequence 3 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) | Experimental | 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 mealThe 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 Intervention Sequence 4 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) | Experimental | 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 mealThe 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 Intervention Sequence 5 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) | Experimental | 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 mealThe 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 Intervention Sequence 6 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) | Experimental | 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 mealThe 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 Intervention Sequence 7 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) | Experimental | 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 mealThe 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 Intervention Sequence 8 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) | Experimental | 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 mealThe 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 Intervention Sequence 9 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) | Experimental | 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 mealThe 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 Intervention Sequence 10 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) | Experimental | 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 mealThe 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 Intervention Sequence 11 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) | Experimental | 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 mealThe 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18 - 75 years
- Body mass index: 18.5 - 30 kg/m2
- (double-loop) Ileostomy with an intact small bowel
- Signed informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oat Protein, low bioavailabilityParticipants will consume a protein meal consisting of cooked whole oat kernels (amount based on body weight, 0.3g of protein/kg bodyweight). | Dietary supplement | Dietary Intervention Sequence 1 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 10 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 11 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 2 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 3 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 4 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 5 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 6 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 7 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 8 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 9 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) |
| Oat Protein, high bioavailabilityParticipants will consume a protein meal consisting of heated oat protein concentrate (amount based on body weight, 0.3g of protein/kg bodyweight). | Dietary supplement | Dietary Intervention Sequence 1 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 10 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 11 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 2 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 3 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 4 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 5 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 6 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 7 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 8 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 9 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) |
| Pea Protein, low bioavailabilityParticipants will consume a protein meal consisting of cooked whole yellow peas (amount based on body weight, 0.3g of protein/kg bodyweight). | Dietary supplement | Dietary Intervention Sequence 1 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 10 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 11 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 2 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 3 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 4 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 5 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 6 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 7 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 8 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 9 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) |
| Pea Protein, high bioavailabilityParticipants will consume a protein meal consisting of heated pea protein isolate (amount based on body weight, 0.3g of protein/kg bodyweight). | Dietary supplement | Dietary Intervention Sequence 1 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 10 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 11 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 2 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 3 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 4 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 5 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 6 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 7 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 8 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 9 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) |
| Protein-free mealParticipants will consume a protein-free meal to correct analyses for endogenous protein losses. | Dietary supplement | Dietary Intervention Sequence 1 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 10 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 11 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 2 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 3 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 4 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 5 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 6 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 7 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 8 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)), Dietary Intervention Sequence 9 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x)) |
Primary outcome
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
2 secondary outcomes
Protein and metabolite profiles in ileostomy digesta
Time frame: 0-5 hours after consumption of test meal (on all 5 study days)
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 and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oat Protein, low bioavailability, Oat Protein, high bioavailability and Pea Protein, low bioavailability in people with Ileostomy - Stoma, run by Örebro University, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Brummer, PhD (004619303731, robert.brummer@oru.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
True ileal digestibility of different plant-based proteins (time frame: 0-5 hours after consumption of test meal (on all 5 study days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.