Digestibility of Different Plant-based Proteins in Humans With Ileostomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oat Protein, low bioavailability, Oat Protein, high bioavailability, Pea Protein, low bioavailability, Pea Protein, high bioavailability.
- Who it may be relevant to
- Registry conditions: Ileostomy - Stoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
True Ileal Digestibility of Different Plant-based Proteins in a Human Ileostomy Model
Overview
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.
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.
Primary outcome measures
- True ileal digestibility of different plant-based proteins [Time frame: 0-5 hours after consumption of test meal (on all 5 study days)]
Secondary outcome measures (2)
- 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
Sweden · 1 center
- Örebro University — Örebro
Identifiers
NCT: NCT06142084 · Dnr 2023-04189-01