Digestibility of Different Plant-based Proteins in Humans With Ileostomy (PAN-Prodig)

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:

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.

Study Overview

• Status: Recruiting
• Conditions: Ileostomy - Stoma
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 11
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Brummer, PhD; Phone Number: 004619303731; Email: robert.brummer@oru.se
• Study Contact Backup: Name: Annalena Kamm, MSc; Phone Number: 0046790676822; Email: annalena.kamm@oru.se

Study Locations

• Sweden
  • Örebro, Sweden, 70182
    • Recruiting
    • Örebro University
    • Contact: Robert Brummer, PhD; Phone Number: 004619303731; Email: robert.brummer@oru.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.
Experimental: 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	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.
Experimental: 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	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.
Experimental: 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	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.
Experimental: 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	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.
Experimental: 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	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.
Experimental: 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	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.
Experimental: 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	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.
Experimental: 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	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.
Experimental: 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	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.
Experimental: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	In vivo data: 0-5 hours after consumption of test meal (on all 5 study days)

Collaborators and Investigators

• Sponsor: Örebro University, Sweden

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Protein; Digestibility; Plant-based
• Other Study ID Numbers: Dnr 2023-04189-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No