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Digestibility of Different Plant-based Proteins in Humans With Ileostomy

ConditionIleostomy - Stoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorÖrebro University, Sweden

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18 - 75 years

Body mass index: 18.5 - 30 kg/m2

(double-loop) Ileostomy with an intact small bowel

Signed informed consent

Disqualifiers

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 design

Design model

Crossover

Treatments tested in this trial

  • Oat Protein, low bioavailability

    Dietary 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 bioavailability

    Dietary 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 bioavailability

    Dietary 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 bioavailability

    Dietary 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 meal

    Dietary supplement

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

Treatment groups

11 Participants
are divided into 11 treatment groups

11

Treatment groups

See each treatment group below.

Group A: Dietary Intervention Sequence 1 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))Experimental treatment 5 interventions
Group B: Dietary Intervention Sequence 2 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))Experimental treatment 5 interventions
Group C: Dietary Intervention Sequence 3 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))Experimental treatment 5 interventions
Group D: Dietary Intervention Sequence 4 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))Experimental treatment 5 interventions
Group E: Dietary Intervention Sequence 5 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))Experimental treatment 5 interventions
Group F: Dietary Intervention Sequence 6 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))Experimental treatment 5 interventions
Group G: Dietary Intervention Sequence 7 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))Experimental treatment 5 interventions
Group H: Dietary Intervention Sequence 8 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))Experimental treatment 5 interventions
Group I: Dietary Intervention Sequence 9 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))Experimental treatment 5 interventions
Group J: Dietary Intervention Sequence 10 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))Experimental treatment 5 interventions
Group K: Dietary Intervention Sequence 11 (Meals: Pea protein (2x), Oat protein (2x), Protein-free (1x))Experimental treatment 5 interventions

Trial outcomes

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Örebro University, Sweden

Lead sponsor

Source ClinicalTrials.gov
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