NCT06142084

Brief 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. 1.How does the digestibility of proteins in the small intestine differ between different plant-based proteins?
  2. 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. 3.How do metabolites in the collected content of the ileostomy bag differ after consuming different plant-based proteins?
  4. 4.Can the in vivo results be compared to results from existing in vitro models?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Sep 2025Sep 2026

First Submitted

Initial submission to the registry

November 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
1.8 years until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

November 15, 2023

Last Update Submit

August 11, 2025

Conditions

Ileostomy - Stoma

Keywords

ProteinPlant-basedDigestibility

Outcome Measures

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

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

Secondary Outcomes (2)

  • Protein and metabolite profiles in ileostomy digesta

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

  • Differences between in vivo and in vitro data

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

Study Arms (11)

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

Dietary Supplement: Oat Protein, low bioavailabilityDietary Supplement: Oat Protein, high bioavailabilityDietary Supplement: Pea Protein, low bioavailabilityDietary Supplement: Pea Protein, high bioavailabilityDietary 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

Dietary Supplement: Oat Protein, low bioavailabilityDietary Supplement: Oat Protein, high bioavailabilityDietary Supplement: Pea Protein, low bioavailabilityDietary Supplement: Pea Protein, high bioavailabilityDietary 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

Dietary Supplement: Oat Protein, low bioavailabilityDietary Supplement: Oat Protein, high bioavailabilityDietary Supplement: Pea Protein, low bioavailabilityDietary Supplement: Pea Protein, high bioavailabilityDietary 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

Dietary Supplement: Oat Protein, low bioavailabilityDietary Supplement: Oat Protein, high bioavailabilityDietary Supplement: Pea Protein, low bioavailabilityDietary Supplement: Pea Protein, high bioavailabilityDietary 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

Dietary Supplement: Oat Protein, low bioavailabilityDietary Supplement: Oat Protein, high bioavailabilityDietary Supplement: Pea Protein, low bioavailabilityDietary Supplement: Pea Protein, high bioavailabilityDietary 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

Dietary Supplement: Oat Protein, low bioavailabilityDietary Supplement: Oat Protein, high bioavailabilityDietary Supplement: Pea Protein, low bioavailabilityDietary Supplement: Pea Protein, high bioavailabilityDietary 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

Dietary Supplement: Oat Protein, low bioavailabilityDietary Supplement: Oat Protein, high bioavailabilityDietary Supplement: Pea Protein, low bioavailabilityDietary Supplement: Pea Protein, high bioavailabilityDietary 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

Dietary Supplement: Oat Protein, low bioavailabilityDietary Supplement: Oat Protein, high bioavailabilityDietary Supplement: Pea Protein, low bioavailabilityDietary Supplement: Pea Protein, high bioavailabilityDietary 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

Dietary Supplement: Oat Protein, low bioavailabilityDietary Supplement: Oat Protein, high bioavailabilityDietary Supplement: Pea Protein, low bioavailabilityDietary Supplement: Pea Protein, high bioavailabilityDietary 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

Dietary Supplement: Oat Protein, low bioavailabilityDietary Supplement: Oat Protein, high bioavailabilityDietary Supplement: Pea Protein, low bioavailabilityDietary Supplement: Pea Protein, high bioavailabilityDietary 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

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

Interventions

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).

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 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).

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 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).

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 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).

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 mealDIETARY_SUPPLEMENT

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

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))

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Örebro University

Örebro, 70182, Sweden

RECRUITING

MeSH Terms

Interventions

Pea Proteins

Intervention Hierarchy (Ancestors)

Plant Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Robert Brummer, PhD

CONTACT

004619303731robert.brummer@oru.se

Annalena Kamm, MSc

CONTACT

0046790676822annalena.kamm@oru.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 21, 2023

Study Start

September 1, 2025

Primary Completion

April 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

August 14, 2025

Record last verified: 2025-08

Locations

SE(1)