Digestibility of Different Plant-based Proteins in Humans With Ileostomy
NCT ID: NCT06142084
Last Updated: 2025-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
11 participants
INTERVENTIONAL
2025-09-30
2026-09-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Body mass index: 18.5 - 30 kg/m2
* (double-loop) Ileostomy with an intact small bowel
* Signed informed consent
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Örebro University, Sweden
OTHER
Responsible Party
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Locations
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Örebro University
Örebro, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Dnr 2023-04189-01
Identifier Type: -
Identifier Source: org_study_id
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